deplin patient brochure

O

VERC

OMIN

G DE

PRES

SION

when your antidepressant

alone isn't enough

Visit www.deplin.com for more information.

A single antidepressant MAY NOT BE ENOUGH to get well.1

People suffering from depression who do not experience a full resolution of all their symptoms are more likely to relapse and each additional episode becomes increasingly more difficult to treat.2

People suffering from depression who do not experience a full resolution of all their symptoms are more likely to relapse and each additional episode becomes increasingly more difficult to treat.2

Achieve Full Remission with a Single Antidepressant

2/3

1/3

Achieve Less Than Full Response with a Single Antidepressant

Trivedi M et al. Am J Psych. 2006;163(1):28-40.

2 out of 3 patients WILL NEED MORE THAN A SINGLE antidepressant.1

Deplin® is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.

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Current therapies MAY NOT ADDRESS all three neurotransmitters.

Depressive symptoms may be linked to an imbalance of one or more of the three neurotransmitters believed to be associated with depression.3

Your doctor may choose a therapy that targets one or more of these neurotransmitters. It is important to share all your symptoms so your doctor can choose the best therapy.

Some depressive symptoms you may experience and should tell your doctor about include:

• Sadness, hopelessness or the inability to feel pleasure

• Feeling tired, tearful or discouraged

• Irritability, anxiousness or low energy levels

• Lack of concentration or motivation


Why do so many people NOT FULLY RESPOND to antidepressants?

Insufficient Amounts of Neurotransmitters

One theory of depression is that the brain is not developing enough neurotransmitters. This may be due to insufficient amounts of L-methylfolate in the brain.3 L-methylfolate is needed to regulate serotonin, norepinephrine and dopamine production. Without enough L-methylfolate, it may be difficult to produce enough neurotransmitters for your antidepressant to work fully.4

Blood Brain Barrier

4.

3. Antidepressant

1. Insufficient L-methylfolate

2. Neurotransmitter Deficiency (serotonin, norepinephrine & dopamine)

Inadequate Response to

Antidepressant

7 out of 10 depressed individuals may have a genetic problem that could affect neurotransmitter production.5


What are the RISK FACTORS for low L-methylfolate6-10 and neurotransmitter deficiency?11

In individuals who suffer from depression, 70% may have a specific genetic factor that limits their ability to convert folic acid or folate from food to L-methylfolate. This is important because L-methylfolate regulates neurotransmitter production.5

Individuals of Hispanic or Mediterranean descent have twice the risk of this genetic problem.12

OTHER RISK FACTORS 6,12,13

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Drugs

Anticonvulsants such as lamotrigine and valproate, methotrexate, sulphasalazine, oral contraceptives, metformin, fluoxetine, niacin, fenofibrates and warfarin

DiseaseDiabetes, atrophic gastritis, Crohn’s, colitis, renal failure and hypothyroidism

LifestyleExcessive alcohol, smoking, and poor nutrition

AgingL-methylfolate in the braindecreases with age


How can deplin® help?

What is deplin®?

Deplin® contains 7.5mg or 15mg of L-methylfolate, the only active form of folate that can cross the blood brain barrier to help the brain regulate important neurotransmitters associated with mood.

How does deplin® work?

Deplin® works by providing higher amounts of L-methylfolate needed by some depressed individuals to regulate serotonin, norepinephrine, and dopamine.3

The L-methylfolate found in Deplin®, a medical food, provides the nutritional requirements to dietarily manage depression by supplying the brain with the L-methylfolate it needs to make the neurotransmitters that regulate mood.

Blood Brain Barrier

4. Enhanced Clinical

Response

3. Antidepressant

1. L-methylfolate

2. Restored neurotransmitter production and release

(serotonin, norepinephrine & dopamine)

11. L-methylfolate . L-methylfolate

D e p l i n ®


deplin® plus an antidepressant

15mg or 7.5mg L-methylfolate (deplin® 15, deplin® 7.5) used along with an antidepressant improves benefits.15

Neurotransmitters (serotonin, norepinephrine and dopamine) are important to maintain your mood. Antidepressants such as SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors) block reabsorption allowing the brain to have greater use of available neurotransmitters.

Since sufficient amounts of these neurotransmitters are needed, combining a therapeutic agent that regulates these neurotransmitters used along with an antidepressant from the start of therapy may lead to clinical response.14

15mg L-methylfolate (Deplin® 15) along with an antidepressant at the start of therapy can help achieve and maintain benefits.14


ACHIEVE AND MAINTAIN... deplin® with an antidepressant

After the 30 day study a 12 month maintenance phase was offered. Of those who had remitted and chose to enter the maintenance phase, over half maintained remission and no one relapsed. n=13

In a 30 day study of 75 adults (18-65 years) with depression, 2X as many depressed individuals taking Deplin® with an antidepressant as a management strategy experienced a response in depressive symptoms compared to those taking a sugar pill + antidepressant.22

Superior Response Rates in 30 Days22

After the 30 day study a 12 month maintenance phase was After the 30 day study a 12 month maintenance phase was After the 30 day study a 12 month maintenance phase was

60 110 160 210 260 310 360 410

0

5

10

15

20

25

Time (Days)

HAM

-D17

Sco

re

Relapse:(HAM-D17>15)

Remission:(HAM-D17≤7)

Prevention of Relapse over 12 Months23

0

10

20

30

40

% o

f Pati

en

ts R

esp

on

din

g (

HA

M-D

17)

Placebo+ Antidepressant

PlaceboPlacebo

14.6%

* p=0.04n=75

Deplin® 15mg+ Antidepressant

DeplinDeplin® ® 15mg15mg

32.3%

*


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N=2y2No Difference in Discontinuation

Due to Adverse Events24

0%

3.7%

Deplin®

+ Antidepressantn=1/42

Placebo+ Antidepressant

n=2/54

% o

f Pati

en

t D

isco

nti

nu

ati

on

2%

4%

6%

8%

10%

2.4%

N/S

There was no difference in discontinuation due to side effects between the group taking Deplin® + antidepressant and those taking sugar pill + antidepressant.24


Are there side effects with deplin®?

Deplin® was well tolerated in both short-term and long-term trials. Side effects did not differ from a sugar pill (placebo). Deplin® is not associated with weight gain, insomnia, or sexual dysfunction.15,22

How do I take deplin®?

For best results, you should take Deplin® 7.5 or 15 as directed by your doctor or medical professional. For most people, Deplin® is taken daily, with or without food. You should fill your prescriptions ahead of time to avoid missing a dose.

When will I feel an effect?

You or those who you interact with the most may begin to notice a difference after taking Deplin® for 1 to 2 weeks, but the full effect may take 4 to 6 weeks.19-21

How long will I need to take deplin®?For some, depression can be an ongoing condition that may require long-term treatment. Your healthcare provider will track your progress and work with you to determine the right length of treatment. Do not stop taking Deplin® without first talking to your doctor or medical professional.

What to expect when taking deplin®

• Motivation• Alertness• Initiative• Concentration• Mood• Sociability

What can I expect?21

You may feel benefit in one or more of the following:


COULD I CORRECT THIS PROBLEM with my diet or folic acid?

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Visit www.deplin.com to get more information and view a series of patient videos.

L-methylfolate is the only form of folate that the brain can use to regulate the neurotransmitters associated with depression.3,16

Synthetic folic acid and dietary folate must be broken down by a lengthy process into L-methylfolate in order to be used by the brain.

Up to 70% of those with depression may have a compromised ability to break down folic acid from supplements or food into L-methylfolate, the only form of folate that can be used by the brain to promote production of serotonin, norepinephrine, and dopamine.5

For more information about depression, you may contact the following organizations:

National Alliance on Mental Illness (NAMI)3803 N. Fairfax Drive, Suite 100Arlington, VA 222031-800-950-NAMI (6264) or www.nami.org

National Institute of Mental Health (NIMH)6001 Executive Boulevard, Room 8184, MSC 9963Bethesda, MD 208921-866-615-NIMH (6464) or www.nimh.nih.gov

Depression and Bipolar Support Alliance (DBSA)730 N. Franklin Street, Suite 501Chicago, IL 606541-800-826-3632 or www.dbsalliance.org

Families for Depression Awareness395 Totten Pond Road, Suite 404Waltham, MA 02451781-890-0220 or www.familyaware.org


This simple, short questionnaire can help you better understand the depression symptoms that are affecting your life. After answering all the questions, share your answers with your doctor.

PHQ-9 SCORING CARD FOR SEVERITY DETERMINATION

for healthcare professional use only

Scoring — add up all checked boxes on PHQ-9

For every : Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3

Interpretation of Total Score

Total Score Depression Severity

Over the last two weeks, how often have you been bothered by any of the following problems. Mark the place on the scale that applies to your response.

My Depression Score

1. Little interest or pleasure in doing things.

Not At All Several Days More than half the Days

Nearly Every Day

2. Feeling down, depressed or hopeless.


Nearly Every Day

3. Trouble falling or staying asleep, or sleeping too much.


Nearly Every Day

4. Feeling tired or having little energy.


Nearly Every Day

Minimal depressionMild depressionModerate depressionModerately severe depressionSevere depression

0-45-9

10-1415-1920-27


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* If you or someone you know experiences suicidal thoughts, talk to someone who can help. Call 1-800-273-TALK (8255) – National Suicide Prevention Lifeline

Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. No permission required to reproduce, translate, display or distribute.

“My Depression Score” DisclaimerThis evaluation tool is not intended to provide medical advice or diagnosis. It is intended for educational purposes only. It is not a substitute for professional medical advice, diagnosis or treatment. You should never ignore or not seek professional medical advice because of something you read on the deplin.com website. If you or someone you know is thinking about suicide you should contact a mental health professional immediately or call the National Suicide Prevention Hotline at 1-800-273-TALK (8255)

5. Poor appetite or overeating.


Nearly Every Day

6. Feeling bad about yourself – or that you are a failure or have let yourself or your family down.


Nearly Every Day

7. Trouble concentrating on things, such as reading the newspaper or watching television.


Nearly Every Day

8. Moving or speaking so slowly that other people could have noticed. Or the opposite – being so fidgety or restless that you have been moving around a lot more than usual.


Nearly Every Day

9. Thoughts that you would be better off dead or of hurting yourself in some way.


Nearly Every Day

Total

+ + +0

10. If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?

Not difficult at all

Somewhat difficult

Very difficult

Extremely difficult

HIGHLIGHTS OF DEPLIN® PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DEPLIN® safely and effectively. See full prescribing information for DEPLIN®.

IDENTITYDEPLIN® is a medical food dispensed by prescription for the clinical dietary management of the metabolic imbalances associated with depression and schizophrenia. Use under medical supervision.

DEPLINEach DEPLIN®15 capsule contains 15.0 mg of L-methylfolate (Metafolin®)* and 90.314 mg Algae-S powder (Schizochytrium).*CAS#151533-22-1

INDICATIONADJUNCTIVE USE IN MAJOR DEPRESSIVE DISORDER

DEPLIN®15 is indicated for the distinct nutritional requirements of individuals who have suboptimal L-methylfolate levels in the cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD) with particular emphasis as adjunctive support for individuals who are on an antidepressant.2-5

ADJUNCTIVE USE IN SCHIZOPHRENIA

DEPLIN®15 is indicated for the distinct nutritional requirements of individuals who have or are at risk for hyperhomocysteinemia and have schizophrenia who present with negative symptoms and/or cognitive impairment, with particular emphasis as an adjunctive support for individuals who have stabilized on antipsychotics.2

DEPLIN®15 is indicated regardless of MTHFR C677T polymorphism genotype.6

DOSAGE AND ADMINISTRATIONThe usual adult dose is one DEPLIN®15 capsule given daily with or without food or as directed under medical supervision.

CONTRAINDICATIONSDEPLIN®15 is contraindicated in patients with known hypersensitivity to any of the components contained in this product.

PRECAUTIONSFolic acid, when administered in daily doses above 0.1mg, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). L-methylfolate may be less likely than folic acid to mask vitamin B12 deficiency.7,8 Folate therapy alone is inadequate for the treatment of a B12 deficiency.

ADVERSE REACTIONSAllergic reactions have been reported following the use of oral L-methylfolate.__________________________________________________________________________

REFERENCES 1. Trivedi M et al. Am J Psych. 2006;163(1):28-40. 2. Paykel ES et al. Psychol Med. 1995;25:1171-1180. 3. Stahl SM. CNS Spectrums. 2007;12(10):739-44. 4. Farah A and Shelton R. Primary Psychiatry 2009;166:1 (Suppl 1):1-8. 5. Kelly CB et al. J Psychopharmacol. 2004;18(4):567-71. 6. Bottiglieri T. 2005;29:1103-12 7. Natural Standard Research Collaboration (NIH).Folate(Folic Acid) Monograph 2009. 8. Hernandez-Diaz. N Engl J Med. 2000:343:1608-14. 9. Morrell M. Curr. 2002;2(2):31-34.10. Tatum IV W et al. Arch Intern Med. 2004;164:137-45 11. Bottiglieri T et al. 2000;69:228-32. 12. Stahl, SM. J Clin Psychiatry.2008. 69;9:1352-53. 13. Sobczynska-Malefora A, et al. Blood Coagulation and Fibrinolysis. 2009;20:279-30214. Godfrey PSA et al. The Lancet. 1990: 336: 392-5. 15. Ginsberg LD, Oubre AY and Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to

SSRI or SNRI Monotherapy in a Major Depressive Episode. (2010, May) Poster presented at the Annual Meeting of the American Psychiatric Association, New Orleans, LA.

16. Willems FF et al. Br J Pharmacol.2004;141(5):825-30. 17. Alpert JE et al. Annals of Clin Psych. 2002;14(1):33-38. 18. Coppen A et al. J. Affective Disorders, 1986;10:9-13. 19. Coppen A & Bailey J. J Affective Disorders. 2000;60:121-30. 20. Guaraldi et al. Annals Clin Psych. 1993;5(2):101-5. 21. Deplin Clinical Evaluation Response Survey. 2007. Data on file.22. Fava M, Shelton R, Zajecka J, et al. L-methylfolate Augmentation of Selective Serotonin Reuptake Inhibitors

(SSRIs) for SSRI-Resistant Major Depressive Disorder: Results of Two Randomized, Double-Blind Trials. (2010, December). Poster presented at the 49th Annual Meeting of the American College of Neuropsychopharmacology, Miami Beach, FL.

23. Zajecka, J et al. L-methylfolate 15mg as Adjunctive Therapy with Selective Serotonin Reuptake Inhibitors Following Acuteh Remission for MDD: Results of a 12-month, Open-Label, Relapse-Prevention Study. (2011, November}.24 Annual 2011 U.S. Psychiatric and Mental Health Congress.Las Vegas, NV.

24. Papakostas G, et al. Am J Psychiatry 2012;169(12):1267-1274.

Pamlab®

4099 Highway 190 East ServiceCovington, LA 70433-4941985-893-4097

Be a step ahead...

Ask your doctor

if deplin® is

right for you.

Be a step ahead...


B R A N D D I R E C T H E A L T H

Deplin® is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression.

Use under medical supervision.

Start deplin® today.Call Brand Direct Health 866-331-6440

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Brand Direct Health o�ers two payment options:

•• Call Brand Direct Health toll-free at 866-331-6440.•• Visit the Brand Direct Health website at www.BDHRx.com.•• Email Brand Direct Health at [email protected]

Talk with Brand Direct Health today about how Deplin® can help you get well, and stay well.

Option 1$144.0090 day supply paid in full at time of orderNo dispensing fee

Option 23 payments of $48.00 90 day supply paid in 3 monthly installmentsPlus a one time $5.00 dispensing fee

Full refund on current purchase. No Return Necessary.

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deplin patient brochure

Documents

neurotransmitter production

medical food

depressive symptoms

medical supervision

risk factors

genetic problem

single antidepressanttrivedi

depressed individuals