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Deplin Patient Brochure
Deplin Patient Brochure
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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.
Sadness, hopelessness or the inability to feel pleasure Feeling tired, tearful or discouraged Irritability, anxiousness or low energy levels Lack of concentration or motivation
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
Some depressive symptoms you may experience and should tell your doctor about include:
2. Neurotransmitter Deciency
3. 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 deciency?11
In individuals who suffer from depression, 70% may have a specic 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
6,12,13
Drugs
Anticonvulsants such as lamotrigine and valproate, methotrexate, sulphasalazine, oral contraceptives, metformin, uoxetine, niacin, fenobrates and warfarin
Disease
Aging
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
Lifestyle
How can
What is
deplin
help?
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.
Deplin
Blood Brain Barrier
3. Antidepressant
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.
deplin
plus an antidepressant
15mg or 7.5mg L-methylfolate (deplin 15, deplin 7.5) used along with an antidepressant improves benets.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 sufcient 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 benets.14
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
deplin
with an antidepressant
40
17
*
30 20 10 0
* p=0.04 n=75
32.3%
14.6%
Placebo + Antidepressant
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
20
Relapse:(HAM-D17>15)
15
HAM-D17 Score
10
Remission:(HAM-D177)
5
Time (Days)
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
N=2y2
10%
% of Patient Discontinuation
8%
6%
N/S
4%
3.7%
2% 0%
2.4%
Deplin + Antidepressant
n=1/42
Placebo + Antidepressant
n=2/54
There was no difference in discontinuation due to side effects between the group taking Deplin + antidepressant and those taking sugar pill + antidepressant.24
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
deplin
deplin ?
Deplin was well tolerated in both short-term and longterm 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 ll your prescriptions ahead of time to avoid missing a dose.
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 rst talking to your doctor or medical professional.
deplin ?
For more information about depression, you may contact the following organizations:
National Alliance on Mental Illness (NAMI) 3803 N. Fairfax Drive, Suite 100 Arlington, VA 22203 1-800-950-NAMI (6264) or www.nami.org National Institute of Mental Health (NIMH) 6001 Executive Boulevard, Room 8184, MSC 9963 Bethesda, MD 20892 1-866-615-NIMH (6464) or www.nimh.nih.gov
Depression and Bipolar Support Alliance (DBSA) 730 N. Franklin Street, Suite 501 Chicago, IL 60654 1-800-826-3632 or www.dbsalliance.org Families for Depression Awareness 395 Totten Pond Road, Suite 404 Waltham, MA 02451 781-890-0220 or www.familyaware.org
Visit
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
My Depression Score
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 0-4 5-9 10-14 15-19 20-27 Depression Severity Minimal depression Mild depression Moderate depression Moderately severe depression Severe depression
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.
1. Little interest or pleasure in doing things. Not At All Several Days More than half the Days More than half the Days More than half the Days More than half the Days Nearly Every Day Nearly Every Day Nearly Every Day Nearly Every Day
3. Trouble falling or staying asleep, or sleeping too much. Not At All Several Days
5. Poor appetite or overeating. Not At All Several Days More than half the Days Nearly Every Day
6. Feeling bad about yourself or that you are a failure or have let yourself or your family down. Not At All Several Days More than half the Days Nearly Every Day
7. Trouble concentrating on things, such as reading the newspaper or watching television. Not At All Several Days More than half the Days Nearly Every Day
8. Moving or speaking so slowly that other people could have noticed. Or the opposite being so dgety or restless that you have been moving around a lot more than usual. Not At All Several Days More than half the Days Nearly Every Day
9. Thoughts that you would be better off dead or of hurting yourself in some way. Not At All Several Days More than half the Days Nearly Every Day
0 Total
10. If you checked off any problems, how difcult have these problems made it for you to do your work, take care of things at home, or get along with other people?
* 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 Pzer Inc. No permission required to reproduce, translate, display or distribute.
This 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)
Deplin is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.
HIGHLIGHTS OF DEPLIN PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEPLIN safely and effectively. See full prescribing information for DEPLIN. IDENTITY DEPLIN 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. DEPLIN Each DEPLIN15 capsule contains 15.0 mg of L-methylfolate (Metafolin)* and 90.314 mg Algae-S powder (Schizochytrium). *CAS#151533-22-1 INDICATION ADJUNCTIVE USE IN MAJOR DEPRESSIVE DISORDER DEPLIN15 is indicated for the distinct nutritional requirements of individuals who have suboptimal L-methylfolate levels in the cerebrospinal uid, 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 DEPLIN15 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 DEPLIN15 is indicated regardless of MTHFR C677T polymorphism genotype.6 DOSAGE AND ADMINISTRATION The usual adult dose is one DEPLIN15 capsule given daily with or without food or as directed under medical supervision. CONTRAINDICATIONS DEPLIN15 is contraindicated in patients with known hypersensitivity to any of the components contained in this product. PRECAUTIONS Folic acid, when administered in daily doses above 0.1mg, may obscure the detection of B12 deciency (specically, the administration of folic acid may reverse the hematological manifestations of B12 deciency, including pernicious anemia, while not addressing the neurological manifestations). L-methylfolate may be less likely than folic acid to mask vitamin B12 deciency.7,8 Folate therapy alone is inadequate for the treatment of a B12 deciency. ADVERSE REACTIONS Allergic reactions have been reported following the use of oral L-methylfolate. REFERENCES
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.
__________________________________________________________________________
Trivedi M et al. Am J Psych. 2006;163(1):28-40. Paykel ES et al. Psychol Med. 1995;25:1171-1180. Stahl SM. CNS Spectrums. 2007;12(10):739-44. Farah A and Shelton R. Primary Psychiatry 2009;166:1 (Suppl 1):1-8. Kelly CB et al. J Psychopharmacol. 2004;18(4):567-71. Bottiglieri T. 2005;29:1103-12 Natural Standard Research Collaboration (NIH).Folate(Folic Acid) Monograph 2009. Hernandez-Diaz. N Engl J Med. 2000:343:1608-14. Morrell M. Curr. 2002;2(2):31-34. Tatum IV W et al. Arch Intern Med. 2004;164:137-45 Bottiglieri T et al. 2000;69:228-32. Stahl, SM. J Clin Psychiatry.2008. 69;9:1352-53. Sobczynska-Malefora A, et al. Blood Coagulation and Fibrinolysis. 2009;20:279-302 Godfrey PSA et al. The Lancet. 1990: 336: 392-5. 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. Willems FF et al. Br J Pharmacol.2004;141(5):825-30. Alpert JE et al. Annals of Clin Psych. 2002;14(1):33-38. Coppen A et al. J. Affective Disorders, 1986;10:9-13. Coppen A & Bailey J. J Affective Disorders. 2000;60:121-30. Guaraldi et al. Annals Clin Psych. 1993;5(2):101-5. Deplin Clinical Evaluation Response Survey. 2007. Data on file. 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. 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. Papakostas G, et al. Am J Psychiatry 2012;169(12):1267-1274.
23. 24.
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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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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 comments@branddirecthealth.com
Talk with Brand Direct Health today about how Deplin can help you get well, and stay well.
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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