depression in the youth and adolescent - who...

Annex to Chapter 6.15: Depression in Young People and the Elderly

Priority Medicines for Europe and the World"A Public Health Approach to Innovation"

Background Paper for Review

Annex toDepression in Young People and the

Elderly

By Eduardo Sabaté

10 August 2004

Please send comments to:

Dr. Eduardo Sabaté: [email protected]. Richard Laing: [email protected]

Anx_6.15-1


Inventory of Clinical Trials already in the Market91

Trial Condition Study Design

Intervention Mechanism

BIOLOGICAL BASIC RESEARCHUse of Complementary and Alternative Medicine Among Older Mexican Americans

Arthritis; Diabetes Mellitus; Fractures; Hypertension; Depression; Urinary Incontinence

65+Observational1993-2000

Adolescence, Puberty, and Emotion Regulation

Mood Disorder; Neurobehavioral Manifestation; Healthy

9-17 & 20-40Observational2001

fMRI

The Psychobiology of Childhood Temperament

Mood Disorders; Anxiety Disorders; Adolescents

9-16Observational2003-?

fMRI

Reward-Related Processes and Brain Function

Depression; Anxiety Disorders; Healthy

9-17 + 20-40Observational/Natural History

Development data

Reward-Related Processes and Brain Function

Depression; Anxiety Disorders; Healthy

9-17 + 20-40Observational/Natural History

Development data

Genetics of Fibromyalgia

Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Depression

12+Observational

Genetic Mapping

Brain Function in Mentally Ill Adolescents

Healthy; Posttraumatic Stress Disorder; Major Depressive Disorder

9-17Observational Study2001-?

functional MRI

Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)

Cardiovascular Diseases; Heart Diseases; Depression; Carotid Artery Diseases; Menopausal Complaints; Menopause

Observational1983-2007

Behavioral and Immunological Factors in Coronary Disease

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression


Mechanisms Linking Depression to Cardiovascular Risk

Depression; Cardiovascular Diseases; Heart Diseases

Age?Co-twins retrospective2001-2005

Relation CVD and depression

University of North Carolina Alumni Heart Study

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Depression


Anx_6.15-2

http://www.clinicaltrials.gov/ct/show/NCT00005398?order=111



































Hostility, Depression, Social Environment and CHD Risk



FMRI Study of Performance During a Probabilistic Reversal Learning Task in Depression

18-50Observational study2004

Neurocardiac Control in Major Depression

AnyObservational2004-?

combine H (2) (15) O positron emission tomography (PET) and analysis of heart rate variability (HRV)

Anxiety and Vagal Control of the Heart in Coronary Disease

Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Death, Sudden, Cardiac; Arrhythmia


Neuroanatomy of Emotion Regulation in Major Depressive Disorder

Major Depressive Disorder

18-50Observational2003

FMRI

Brain Regulation of Emotions in People with Depression and Anhedonia



FMRI

Effect of Acetylcholine on Thinking and Emotion in Individuals with Mood Disorders

Mood Disorders 18-45Observational2003

ScopolaminefMRI

Framingham Offspring Study: Psychosocial Risk Factors

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression; Atrial Fibrillation

Observational Study2001-2003

Brain Imaging in Depression

Depression; Bipolar Disorder

18-50Observational2002-2003

Drug: [O-15] Water Drug: [F-18] FP-TZTP

Dynamics of Leptin and Endocrine Function

Healthy; Involutional Depression


Leptin as hypothalamus regulator and determinant of major depression

Effects of Hydrocortisone in Patients with Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorders; Healthy

18-60Observational2002-?

PET Scan

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Brain Chemical Receptor Effects in Patients with Panic Disorder and Post-Traumatic Stress Disorder

Panic Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder

Observational2001

Drug: O15 Water Drug: FCWAY Drug: flumazenilPET Scan

5-HT1A and BZD receptor function is abnormal in patients with PD, PTSD, and depression. Stress hormone cortisol effects on 5-HT1A and BZD receptors

Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?


Observational2001

Examination of Brain Serotonin Receptors in Patients with Mood Disorders

Mood Disorder 18-60Observational Study2001-?

Drug: 15 O-water Drug: FCWAYPET Scan

serotonin 1A (5-HT1A) receptor function is abnormal in patients with mood disorders

Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)

Depressive Disorder; Mood Disorder; Psychomotor Agitation


Neuroimaging of St. John's Wort-Induced Changes of Serotonin Metabolism in Normal Subjects

Healthy; Mood Disorder


Drug: Hypericum (LI-160)

Consequences of Conjugal Bereavement in Adults

Bereavement; Depressive Disorder; Immunologic Disease; Mental Disorder; Sleep Disorder

?1997-2002

Effects of Sex Hormones on Circadian Rhythm in Men and Women

Bipolar Disorder; Circadian Rhythm; Depressive Disorder


Study of the Hypothalmic-Pituitary-Adrenal (HPA) Axis and its Role in Major Depression

Fatigue Syndrome, Chronic; Healthy; Mood Disorders

AnyObservational1995-2000

Glucocorticoid Effects on Cellular Cytokine Release

Depressive Disorder; Fatigue Syndrome, Chronic; Fibromyalgia; Healthy; Inflammation

AnyObservational1994-2000

Use of Repetitive Transcranial

18-70Observational

Repetitive Transcranial

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Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD)

1997-? Magnetic Stimulation (rTMS)

Impact of Sleep Disordered Breathing in Older Adults

Cardiovascular Diseases; Hypertension; Depression; Sleep Apnea Syndromes; Lung Diseases

Males Age?Observational1994-1998

Prediction of Quality of Life in Cardiovascular Disease

Cardiovascular Diseases; Cerebrovascular Accident; Hypertension; Depression; Heart Diseases


The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders

Depressive Disorder; Healthy; Mental Disorders; Mood Disorders


Perimenopause-Related Mood and Behavioral Disorders

Depressive Disorder; Healthy


Study of Menstrually-Regulated Mood and Behavioral Disorder

Mental Disorder; Mood Disorder


Clinical trials of two non-drug treatments for chronic depression

Mood Disorders; Depressive Disorders; Depression; Chronic depression; Nonseasonal depression

18-65Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Device: Bright light boxDevice: Negative ion generator

Circadian clock

The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression

Perimenopause; Depression

HRT Withdrawal

Serotonin Function During Depression

Depression, Involutional; Healthy

18-60Experimental Clinical PhysiologyGenetic Mapping

Drug: [O-15] Water Drug: [F-18] FDGPET Scan

tryptophan depletion & central serotonergic systems

MRI Study of Brain Activity and Risk for Depression in

Involutional Depression; Anxiety Disorders

10-17Observational/Natural History

Adolescent under risk (depressed parents)

Anx_6.15-5































Adolescents Brain functioning w/ MRI

Heart Disease Risk Factors in Major Depression

Adrenal Gland Hyperfunction; Cardiovascular Disease; Involutional Depression

18-65Observational/Natural History

IHD Factors

Genetics of Recurrent Early-Onset Depression

Depression 18-70ObservationalGenetic mapping

Genetic Risk Factors

Use of Bone Biopsy to Better Understand the Causes of Decreased Bone Mineral Density in Depression

Bone Diseases, Metabolic; Depression, Involutional; Osteoporosis

Any with OPObservational

Bone Biopsy for Histomorphometry and Analysis of Bone Marrow

Unknown

Bone Mineral Density in Women with Major Depression

Healthy; Involutional Depression; Osteoporosis

ObservationalDiagnostics Any with OP

non-radioactive calcium isotopes + dual X-ray absorptiometry (DEXA) scan

Unknown

Women's Use of Alternative Medicine: A Multiethnic Study

Uterine Fibroids; Osteoporosis; Urinary Tract Infection; High Blood Pressure; Heart Disease; Arthritis; Depression; Headaches

18+ FemalesObservational2001-2001

PSICOLOGICALBASIC RESEARCHValidation and Exploration of Sleep and Mood Predictors

Sleep Apnea Syndromes; Depression; Lung Diseases; Sleep


Major depression and inflammatory risk markers for coronary heart disease

Depression 18-55Observational

Mediators of Social Support in Coronary Disease

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Depression

Observational Study1992-1998

Interactions of Depressed Mothers with Their Infants

Healthy; Depression

Child development

Psychosocial Acquired 8-18

Anx_6.15-6

































Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children

Immunodeficiency Syndrome; Depressive Disorder; HIV Infections

Observational

Study of the Psychological Development of Children of Parents with and without Affective Disorders

Bipolar Disorder; Involutional Depression; Mood Disorder

Observational/Natural History

Adolescent under risk (depressed parents)

Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants

Depression 18+Naturalistic

SSRI decrease platelet serotonin

TECHNOLOGYCLINICAL RESEARCHTreatment for Adolescents With Depression Study (TADS)

Major Depressive Disorder; Depression

12-17yoRCT, Placebo, C/EPhase III

Drug: Fluoxetine Behavior: Psychotherapy

SSRI

Treatment Of Resistant Depression In Adolescents (TORDIA)

Major Depressive Disorder; Dysthymic Disorder; Depression

12-18 yoRCT, Efficacy StudyPhase III

Drug: fluoxetine (Prozac) Drug: venlafaxine (Effexor XR) Procedure: Cognitive Behavioral Therapy (CBT) Drug: citalopram (Celexa)

Optimizing ProtocolSSRI vs Non-SSRI

Clinical Trial of Memantine for Major Depression

Depression 18-80yoSafety & EfficacyPhase III

Memantine HCL glutamatergic system

Riluzole to Treat Major Depression

Depression 18-70yoSafety/EfficacyPhase II

Riluzole antiglutamatergic and neuroprotective properties

Examination of a Soy-Based Supplement for Major Depression

Depression 18+RCT Safety/efficacy

soy isoflavone genistin

phytoestrogen and protein tyrosine kinase inhibiting properties

Antidepressant Treatment of AIDS Related Depression.

Depression 18-65yoRCTPhase II

Imipramine hydrochloride

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Depression 18-75RCTPhase IV

Drug: citalopram Drug: BuproprionSR Drug: buspirone Drug: Lithium Drug: mirtazapine Drug: nortriptyline

Protocol Optimization

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Drug: sertraline Drug: tranylcypromine Drug: VenlafaxineXR Behavior: Cognitive Therapy Drug: T3 (Triiodothyronine)

Preventing the Return of Depression in Elderly Patients

Depression 60-80RCTPhase ?

Nortriptyline Chronic therapy for unsustainable remissions

Olanzapine Versus Active Comparator in the Treatment of Depression in Patients with Schizophrenia

Depression; Schizophrenia; Schizoaffective Disorder

18-60RCTPhase IV

Olanzapine and investigational agent

N/a

Antidepressant Treatment of Melancholia in Late Life

Depression; Melancholia

60+RCTEfficacy & Safety

Drug: SertralineDrug: Nortriptyline

SSRI vs TCAs

Clinical Trial of Estrogen for Postpartum Depression

Postpartum Depression

20-45RCTSafety & EfficacyPhase II

17 beta-estradiol declining estradiol secretion

Depression in Alzheimer's Disease (DIADS-2)

Alzheimer's Disease; Depression

All Alzheimer patientsRCT Phase III

Drug: sertraline (Zoloft) Drug: Placebo

Biological Aspects of Depression and Antidepressant Drugs

Depression 21-69RCT

Drug: paroxatine Drug: Desipramine

Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

Smoking; Depression

18-65RCTPhase II

Drug: Fluoxetine Behavior: Behavioral group smoking cessation treatment

Unknown

Depression and Health Outcomes in Refractory Epilepsy

Depression; Epilepsy

21-75RCTCompliancePhase III

Drug: sertraline Behavior: cognitive behavior therapy

Comparison Sertaline vs CHT

Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients with Major Depression and Pain

Depression; Pain 18+RCTSafety/Efficacy Study

Duloxetine Hydrochloride

na

Treatment of Bipolar Disorder; 8-18 Fluoxetine Na

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Depression in Youth with Bipolar Disorders

Depression RCTPhase III

Treatment of Depression in Parkinson's Disease Trial

Parkinson Disease; Depression

35-80RCT Safety/Efficacy StudyPhase II

Drug: nortriptyline Drug: paroxetine

Magnetic Stimulation for Parkinson Disease

Parkinson's Disease; Depression

40-75RCT

Procedure: Prefrontal transcranial magnetic brain stimulation & ECT

Neurostimulation improve mood and psychomotor

Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes

Depression; Mood Disorder; Anxiety Disorder; Healthy

9-17Observational

Fluoxetine Improve attention and emotional memory

Treatment of Depression with Massage in HIV

Acquired Immunodeficiency Syndrome; HIV Infections; Depression

16+RCT EfficacyPhase II

Procedure: Massage Therapy

Plasma cortisol increases?

Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients

Depression; Hypertension

25-65RCT - Pharmacodynamics

Drug: paroxetine Behavior: ongoing psychological screening

Platelets of hypertensive patients with depressive symptomatology are hyper-responsive to serotonin

Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Anxiety Disorder; Depression; Fatigue; Non-small cell lung cancer

Any with SCCRCT

Drug: cisplatin Drug: fluoxetine Drug: gemcitabine Procedure: chemotherapy Procedure: psychosocial assessment/care Procedure: supportive care/therapy

Improving treatment protocol

Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

adult brain tumor; brain metastases; cognitive and functional effects; Depression; Fatigue; Quality of Life

18+RCT

Drug: methylphenidateComplications of therapy assess/mgtFatigue assess/mgtPsychosocial assess/mgtQuality-of-life assessmentRadiation therapySupportive care/therapy

Improving QoL

PUFA Augmentation in Treatment of Major Depression

Major depression 18-65RCT EfficacyPhase III

Drug: Polyunsaturated Fatty Acids (PUFA) Drug: Citalopram

PUFA enhance Antidepressant therapy

Treatment of Major Depression with St. John's Wort

Major Depression 18+RCT efficacy and safety

Drug: Sertraline Drug: Hypericum perforatum (St.

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(Hypericum) Comparative study of a natural medicine

John's wort)

Treatment Resistant Depression Study

Depression; Major Depressive Disorder

18-85RCT Phase III2002-open

risperidone

Medication Treatment for Psychotic Depression

Depression; Major Depressive Disorder

18+RCT Safety & Efficacy2003-2007

Drug: Olanzapine Drug: Sertraline Drug: Lithium

First trial MD with delusions funded by NIMH

Raloxifene and Rimostil for Perimenopause-Related Depression

Climacteric Depression

AnyRCT Phase IV2002-?

Drug: Evista, Rimostil, Alora

Selective estrogen receptor modulators (SERMS)

Transcranial magnetic stimulation in depression

Depression 18+RCT Phase II1999-2001

Device: repetitive transcranial magnetic stimulation

Multiphase Efficacy Study of venlafaxine ER to Treat Recurrent Depression

Depression 18+RCTPhase IV2002-?

Drug: Venlafaxine ER

Drug Therapy to Treat Minor Depression

Depression 18-85RCT2003-?

Drug: Citalopram Drug: St. John's Wort

Preventing the Recurrence of Depression with Drugs and Psychotherapy

Depression 18+RCT EfficacyPhase IV2002-?

Behavior: Cognitive Therapy Drug: Antidepressant medications

CT to avoid recurrence

Duloxetine vs. active comparator for the treatment of depression

Depression 18+RCT EfficacyPhase IV

Drug: Duloxetine HydrochlorideDrug: Other

Electroconvulsive Therapy (ECT) Versus Drug Therapy for the Treatment of Depression

Depression 18-85RCT Efficacy & Safety

Drug: Lithium Drug: Nortriptyline Procedure: Continuation Electroconvulsive Therapy

For avoiding relapse after ECTCompares Drugs vs C-ECT

Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression

Depression 18+RCT2002-?

Procedure: Electroconvulsive Therapy (three application procedures)

Improving technique

Anx_6.15-10


































Duloxetine vs. active comparator in the treatment of patients with depression

Depression 18+RCTPhase IV2004?

Drug: Duloxetine Hydrochloride

An Investigational Drug Compared to a Marketed Drug and Placebo in the Treatment of Patients with Depression

Depression 18+RCTPhase III2004?

Drug: Investigational antidepressant drug

Participant Features Affecting Depression Treatment

Depression 18-66RCT Efficacy2003-2007

Drug: Escitalopram Behavior: Interpersonal Psychotherapy

Comparative

Medication Treatment for Depression in Nursing Home Residents

Depression 65+RCT Safety/Efficacy StudyPhase IV2003-2008

Drug: Antidepressants

Acupuncture in the Treatment of Depression

Depressive Disorders; Depression

18-60RCTPhase III1997-2002

Procedure: Acupuncture

Magnetic Stimulation Therapy for Treating Vascular Depression

Depressive Disorder; Depression

51-89RCT Efficacy/SafetyPhase III2001-?

Procedure: Repetitive Transcranial Magnetic Stimulation Drug: Citalopram

Treatment of Vascular Depression

Depressive Disorder; Depression

60+RCT efficacy and Pharmacocinetic

Drug: Sertraline (Zoloft) Procedure: MRI Scan Procedure: Cognitive Testing Procedure: EKG

Ethnic Variations in Antidepressant Response

Depression; Depressive Disorder

18-70RCT EfficacyPhase IV2002

Drug: Citalopram

Research Evaluating the Value of Augmenting Medication with Psychotherapy (REVAMP)


18-75RCT Efficacy2003-2006

Behavior: Supportive Therapy Behavior: Cognitive Behavioral Analysis System of Psychotherapy Drug: Sertraline Drug: Escitalopram Drug: Bupropion SR or XL Drug: Venlafaxine XR Drug: Mirtazapine

ST in drug failure cases

Improving Hispanic Retention in

Depression; Depressive

Hispanics 18-65Non-

Drug: Sertraline Drug: Venlafaxine

Treatment retention

Anx_6.15-11
































Antidepressant Therapy

Disorder Ramdomized2002-2004

Extended Release

Electroacupuncture for Major Depression


18-80RCT Phase II

Procedure: electroacupuncture

Sertraline and Cognitive Therapy in Depressed Alcoholics

Alcoholism; Depression

18-65RCT EfficacyPhase II?-2002

Drug: sertraline (Zoloft) Behavior: cognitive behavior therapy

Sertraline for Alcohol Dependence and Depression


21-65RCT Phase IV?-2004

Drug: naltrexone (Revia)Drug: sertraline (Zoloft)

Drug Treatment for Depressed Alcoholics (naltrexone/fluoxetine)


18-65RCT Phase IV?-2005

Drug: naltrexone (Revia) Drug: fluoxetine (Prozac)

Treating Alcohol Use In Older Adults With Depression


55+RCT Phase IV1999-2002

Drug: NALTREXONE

Relapse Prevention for Bipolar Type-II Disorder

Bipolar Disorder; Depression

18+RCT Phase IV

Drug: Fluoxetine Drug: Lithium

Antidepressant Medication Treatment for Depression in Individuals with Congestive Heart Failure

Heart Failure, Congestive; Depression

45+RCT EfficacyPhase III?

Drug: Sertraline

The Depression in Alzheimer's Disease Study (DIADS)

Alzheimer Disease; Depression

AnyRCT Phase IV?

Drug: Sertraline [Zoloft]

Preventing Post-Stroke Depression

Depression; Cerebrovascular Accident

31-89RCT Phase III2002-?

Drug: Nortriptyline Behavior: Problem Solving Therapy Drug: Escitalopram

Optimizing Electroconvulsive Therapy for Depression

Depression; Depressive Disorder; Bipolar Disorder

18+RCT Phase IV2001-2006

Procedure: Electroconvulsive therapy Drug: Nortriptyline Drug: Venlafaxine Drug: Lithium

SAM-e for the Treatment of Depression in Patients with Parkinson's Disease

Parkinson's Disease; Depression

30-80RCT2003-2006

Drug: s-adenosyl-methionine Drug: escitalopram

Sertraline Compared With

Depression; unspecified adult

18+RCT

Drug: Hypericum perforatum

Anx_6.15-12








































Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer

solid tumor, protocol specific

? Drug: sertraline Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: herbal medicine / botanical therapy Procedure: nutritional supplementation Procedure: psychosocial assessment/care Procedure: supportive care/therapy

Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment

unspecified childhood solid tumor, protocol specific; Depression; neurotoxicity

6-17RCT Phase II

Drug: dextroamphetamine-amphetamine Drug: methylphenidate Procedure: chemoprotection Procedure: complications of therapy assessment/management Procedure: neurotoxicity attenuation Procedure: supportive care/therapy

Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders

Bipolar Disorder; Mood Disorder; Unipolar Depression

18-90Interventional StudyPhase II1996-?

Device: Magstim Super Rapid Magnetic Stimulator Device: Cadwell MES-10

Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial

Bipolar Disorder; Involutional Depression; Mood Disorder

AnyRCT Phase II1999-2002

Drug: Ethyl Eicosapentaenoic Acid Drug: OmegaBrite

omega-3 fatty acids in the form of eicosapentaenoic ethyl esters (EPA) = Mood stabilizer

Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL ) in the Treatment of Patients with Bipolar Depression

Bipolar Disorder; Depression, Bipolar

18-65RCT Phase III?

Drug: SEROQUEL (quetiapine fumarate) Tablets

Treatment of Adolescent Suicide Attempters (TASA)

Major Depressive Disorder; Depressive Disorder not

12-18RCT Phase III2004

Drug: fluoxetine Drug: sertraline Drug: citalopram Drug: escitalopram

Anx_6.15-13





















otherwise specified (NOS); Dysthymic Disorder

Drug: buproprion Drug: mirtazapine Drug: venlafaxine Drug: lithium Behavior: Cognitive Behavioral Therapy

Adult Outpatients with Major Depressive Disorder


18-75RCT Phase III?

Drug: DVS-233 SR

Efficacy And Safety Of Three Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder


18-75Phase III?

Drug: DVS-233 SR

Study of Duloxetine in Elderly Patients with Major Depressive Disorder

Depression, Cognition

65+RCT Phase III

Drug: Duloxetine Drug: "Investigational Drug"

Comparing

Acute Treatment of Bipolar II Depression

Bipolar Depression 18-55RCT Phase III2003

Drug: Lithium Drug: Lamotrigine

The Treatment of Children and Adolescents with Treatment-Resistant Depression

Bipolar Disorder Observational2002-2004

Paroxetine (Paxil), sertraline (Zoloft) or fluoxetine (Prozac

Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression

Bipolar Disorder 18+RCT Efficacy/Safety2002-2004

Felbamate reduces glutamatergic throughput via inhibition of glutamate release and NMDA, AMPA, and metabotropic glutamate receptor blockade

Evaluation of Clonazepam and Paroxetine for Panic Disorder with Depression

Panic Disorder 18+RCT Phase IV2002

clonazepam SSRI

Neural Correlates of Depressive Symptoms and Reward Related Mechanisms Following AMPT Depletion in Remitted Depressed Patients Off Treatment and Healthy Controls

Neurophysiology 18-60Observational2004

Alpha-methyl-paratyrosine (AMPT)fMRI

Catecholamine depletion (CD)

The Effects of Dutasteride on Mood, HPA Axis,

30-45RCTPhase II

Drug: Dutasteride 5 alpha-reductase inhibitor blocks progesterone

Anx_6.15-14






























and Serum Allopregnanolone Levels in Women with Menstrual-Related Mood Disorders and Controls

2004 metabolism (allopregnanolone)

Clinical Trial of Pramipexole in Bipolar Depression

Bipolar Disorder 18-60RCT Safety/EfficacyPhase II2001-?

Pramipexole +lithium or divalproex

An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907, in Combination with Citalopram in Treatment Resistant Depression

Depressive Disorder

18-65RCT Safety/EfficacyPhase II2003-?

Drug: MDL100.907 5-hydroxytryptamine 2A (5-HT2A) antagonist

Yohimbe to Induce Rapid Antidepressant Effects

18-60RCT Safety/EfficacyPhase II2004-?

Yohimbe activate the noradrenergic system during REM sleep

Treatment of Mid-Life-Related Mood Disorders

Depressive Disorder; Mood Disorder

40-65RCT Safety/efficacy1995-2004

Drug: Dehydroepiandrosterone

DHEA levels associated to depression

Continuation Electroconvulsive Therapy vs Medication to Prevent Relapses in Patients with Major Depressive Disorder


18-80RCT Safety/efficacyComparative Phase IV1997-?

Drug: Nortriptyline-lithium (NOR-Li) Procedure: Bilateral electroconvulsive therapy (ECT) Drug: Continuation therapy Behavior: Continuation ECT

Treatment of Patients with Major Depressive Disorder with an Investigational Compound


18+RCT Safety/efficacy

Experimental Compound

Open-Label Treatment with Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients with Major Depression


18+Non-Ramd Phase III2002

Drug: duloxetine

A 6 Week Study to Determine the Effectiveness of


18-65RCT Phase II?-2004

Drug: R228060 Drug: Placebo and Paroxetine

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R228060 in Adult Subjects with Major Depressive Disorder

Efficacy And Safety Of Two Fixed Doses Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder


18-75RCT Phase III?

Drug: DVS-233 SR

DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder


18-75RCT Phase III?

Drug: DVS-233 SR

Combination Therapy for the Treatment of Bipolar Disorders

Bipolar Disorder 16+RCT Phase III2002-2005

Drug: Lithium Drug: Lamotrigine Drug: Divalproex

Clinical Trial of Leuprolide Acetate for the Treatment of PMS

Depressive Disorder; Mood Disorder

18-40RCT safety/efficacy1990

Drug: Luprolide Acetate 3.75 mg

New Drugs in the Treatment of Mood Disorders

Anxiety Disorder; Mood Disorder; Psychotic Disorder

18-75RCT Phase II1995-2001

Lamotrigine (Lamictal) and Gabapentin (Neurontin)

Anticonvulsivants

Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression

Bipolar Disorder; Depressive Disorder

18+RCT Comparative1995-2002

Buproprion (Wellbutrin).Sertraline (Zoloft).Venlafaxine (Effexor)

High Intensity Light Therapy in Alzheimer's Disease

Alzheimer's Disease; Dementia

60+RCT2003-2004

Device: high-intensity light therapy

Combined Hormone Replacement in Menstrually-Related Mood Disorders

Premenstrual Syndrome

18-502000-?

estradiol or progesteroneleuprolide acetate

Clinical Trial of Propranolol for Seasonal Affective Disorder

Seasonal Affective Disorder; Healthy

18-50RCT Safety/Efficacy2001-?

Propanolol Inhibitation of Melatonine which regulate light circadian cycles

Clinical trials of three non-drug treatments for winter depression (SAD).

Seasonal Affective Disorder; Mood Disorders; Depressive Disorders

18-70RCT1998-2003

Device: bright light box Device: dawn simulator Device: negative ion generator

PSYCOLOGICAL

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CLINICAL RESEARCHEvaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model

Hypercholesterolemia; Hypertension; Depression; Diabetes Mellitus, Type 2

Females 30-45RCT2000-?

Behavior: Health at Every Size (HAES) Behavior: Diet (Traditional, moderate energy restriction)

Therapy for Depressed Elders with Thought Problems

Depression; Cognition Disorders

60+RCT Efficacy PhaseIII2002-2007

Behavior: Problem Solving Therapy Behavior: Brief Supportive Therapy

Depressed elderly with executive dysfunction respond poorly to antidepressants

Cognitive and Drug Therapy for Drug-Resistant Depression

Depression; Anxiety Disorders; Personality Disorders; Drug-resistant depression

21-60yoRCTIntegrating ProtocolCompliance

Behavior: Cognitive therapyDrug: Desipramine

Optimizing Clinical Protocol

Depression In Juvenile Diabetics

Depression; Diabetes Mellitus, Insulin-Dependent

8-16Open label

Behavior: psychotherapyAdjusted Contextual Psychotherapy

na

Treatment of Depression in Patients with PTSD

Stress Disorders, Post-Traumatic; Depression

21+RCT

Self-management therapy; Psychoeducational group therapy

Efficacy of Telepsychiatry in the Treatment of Depression

Depression AnyRCT

Telepsychiatry

Psychological Treatments for Scleroderma

Pain; Depression; Scleroderma; Systemic Sclerosis

18-85 Behavior: Cognitive-behavioral therapy Behavior: Disease/health education

Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer

18+RCT

Procedure: complications of therapy assessment/management Procedure: fatigue assessment/management Procedure: psychosocial assessment/care Procedure: supportive care/therapy

Improving QoL

Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation...

adult Hodgkin's lymphoma; adult non-Hodgkin's lymphoma; Anxiety Disorder; childhood acute myeloid leukemia and other myeloid malignancies;

18+RCT

Procedure: pain therapy Procedure: psychosocial assessment/care Procedure: supportive care/therapy

Decreasing Pain

Treatment of Depression in

Depression; Major Depressive

60+RCT Efficacy

Behavior: Pleasant Events-Based

Anx_6.15-17
































Nursing Homes Disorder 2002-2005 Behavioral Intervention

Therapy for Depression with Co-occurring Panic or Anxiety Symptoms

Depression; Mood Disorder; Anxiety Disorder; Panic Disorder; Major Depressive Disorder

18-60RCT EfficacyPhase II2002-2004

Behavior: Interpersonal Psychotherapy (IPT) Behavior: IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)

Treatment of Depressed Women Who Have Been Sexually Abused

Depression 18-65RCT2001-?

Behavior: Schema Therapy

Treatments for Depression: Drug vs. Psychotherapy

Depression 18-70RCT2001-2006

Behavior: Supportive Expressive Therapy Drug: Sertraline Drug: Pill Placebo Drug: Venlafaxine

Optimization

Treatment for Depression in the Primary Care Setting

Depression 18+RCT EfficacyPhase IV

Behavior: Problem-Solving Treatment for Primary Care

Treatment for Depressed Preadolescent Girls

Depression Female 9-13RCT Efficacy2002

Behavior: Cognitive Behavioral Therapy Behavior: Parent Training

CBT vs CBT plus Parent Training

Prevention of Depression in At-Risk Adolescents

Depression 13-17RCT2003-2008

Behavior: Cognitive Behavioral Program

Reducing Symptoms of Depression in Low-Income Mothers

Depression 15+RCT Safety/Efficacy2003-2008

Procedure: Modified Interpersonal Therapy

Adding Exercise to Antidepressant Medication Treatment for Depression

Depression 18-65RCT2003

Behavior: Exercise As coadyudant for SSRI

Preventing Depression in Patients with Macular Degeneration

Depression; Macular Degeneration

65+RCT2001-2005

Behavior: Problem Solving Treatment

Vs Usual care

Reducing Depression in Caregivers to People with Dementia

Dementia; Depression

50+RCT Phase II2002-2004

Behavior: Behavioral Skills Training

Effects of Therapist Behavior on the Treatment of

Depression; Depressive Disorder;

13-18Non-ramdomized

Behavior: Cognitive Behavioral Therapy

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Depressed Adolescents

Dysthymic Disorder 2003-2005

Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)

Seasonal Affective Disorder; Depression

18+RCT2002-2004

Behavior: Light Therapy Behavior: Cognitive Behavioral Therapy Behavior: Light Therapy plus Cognitive Behavioral Therapy

Middle School to High School Transition Project

Depression; Depressive Disorder; Substance-Related Disorders

12-15RCT2003-2007

Behavior: Coping and Support Training for Transition program

Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

18-75RCT? Phase III1995-2004

Behavior: social support

Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Quality of Life; Anxiety Disorder; Depression; unspecified adult solid tumor, protocol specific

18+?

Procedure: psychosocial assessment/care Procedure: quality-of-life assessment Procedure: supportive care/therapy

CVD Risk and Health in Postmenopausal Phytoestrogen Users

Bone Diseases; Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Ischemia; Osteoporosis; Postmenopause

45-74 FemaleRCTPhase III1997-2004

Behavior: dietary supplements Drug: genistein Behavior: diet, soy proteins

Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer

weight changes; Quality of Life; Depression; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

18+InterventionalPhase II?

Procedure: complications of therapy assessment/management Procedure: quality-of-life assessment Procedure: supportive care/therapy

Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

stage I breast cancer; stage II breast cancer; stage I prostate cancer; stage II

65+RCT?

Procedure: fatigue assessment/management Procedure: nutritional support

Anx_6.15-19



























prostate cancer; Fatigue; Nutrition; psychosocial effects/treatment; ...

Procedure: physiotherapy Procedure: psychosocial assessment/care Procedure: quality-of-life assessment Procedure: supportive care/therapy

Clinician Managed Interpersonal Psychotherapy

Depression, Postpartum

18+ FemaleRCT?

Behavior: Interpersonal Psychotherapy (IPT) Behavior: Clinician Managed Interpersonal Psychotherapy (CM-IPT)

Group Therapy for Postpartum Depression


18+ FemaleRCT Efficacy2002-?

Behavior: Mother-Infant Psychotherapy Behavior: Interpersonal Psychotherapy

Prevention of Postpartum Depression in Low-Income Women


18-45 FemalesRCT2001-?

Behavior: Survival Skills for Moms with New Babies

Pharmacologic Treatment of PTSD in Sexually Abused Children

Posttraumatic Stress Disorder; Major Depressive Disorder; Anxiety Disorders

10-18RCT Phase III2001-2006

Drug: Trauma-focused Cognitive Behavioral Therapy plus Sertraline Drug: Trauma-focused Cognitive Behavioral Therapy plus Placebo

Treatment of Post Traumatic Stress Disorder in Patients with other Mental Illnesses

Stress Disorders, Post-Traumatic

18-65RCT Efficacy Study2002-2004

Behavior: Cognitive Behavior Treatment

Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma

Leukemia; Lymphoma, Non-Hodgkin

18-80RCT Efficacy Phase II2002-?

Behavior: Music Imagery

HEALTH CARE RESEARCHEffectiveness of Team Treatment of Depression in Primary Care

Depression 18+Phase II

SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure

Collaborative Care Model – Improving Chronic Care

An Integrated Model of Primary Care in Mental Health

Depression 18+RCT

Mental Nurse Clinic Improving Health Care

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Prevention of Suicide in the Elderly

Depression 60+RCT-Prevention

Early Dx by using models

Treatment for Post-Stroke Depression

Stroke; Depression Any with StrokeRCT

Models of care

Screening Evaluation for Women with Postpartum Depression

Postpartum Depression

AnyObservationalDx

None

Outreach and Treatment for Depression in the Labor Force

Depression 18+RCT Efficacy2003

Behavior: Care manager outreach and monitoring

A Case Finding and Referral System for Older Veterans within Primary Care

Depression; Urinary Incontinence; Geriatrics

65+RCT1996-2001

System: Casefinding and Referral System

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depression in the youth and adolescent - who...

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