Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PARNATE or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PARNATE is not approved for use in pediatric patients. (See WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
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PARNATE SUMMARY
Chemically, tranylcypromine sulfate is (±)- trans -2-phenylcyclopropylamine sulfate (2:1). Each round, rose-red, film-coated tablet is debossed with the product name PARNATE and SB and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine.
PARNATE (tranylcypromine) is indicated for the following:
For the treatment of Major Depressive Episode Without Melancholia.
Parnate (tranylcypromine sulfate) should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.
The effectiveness of Parnate has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association’s Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration and suicidal ideation or attempts.
The effectiveness of Parnate in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.
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NEWS HIGHLIGHTSMedia Articles Related to Parnate (Tranylcypromine)
Study Of Combined Depression-Alcoholism Treatment Shows Higher Abstinence Rate
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2010.03.16]
Combining the antidepressant sertraline with the alcohol dependence treatment naltrexone produced a 54 percent abstinence rate in patients with both major depression and alcohol dependence, whereas the rates were only 21 to 28 percent for patients taking a placebo, sertraline only, or naltrexone only...
When Personality Makes Drugs Ineffective In Depression
Source: Depression News From Medical News Today [2010.03.10]
A study published in the current issue of Psychotherapy and Psychosomatics addresses the role of personality factors in moderating treatment response in depression...
Online Dating And The Link Between Depression And Relational Uncertainty
Source: Depression News From Medical News Today [2010.03.09]
There's no doubt that meeting partners on the Internet is a growing trend. But can we trust the information that people provide about themselves via online dating services? And why is depression so dissatisfying in relationships? These two questions are explored in articles appearing in the latest issue of the Journal of Social and Personal Relationships, published by SAGE...
Major Depression More Than Doubles Risk Of Dementia Among Adults With Diabetes
Source: Depression News From Medical News Today [2010.03.08]
Adults who have both diabetes and major depression are more than twice as likely to develop dementia, compared to adults with diabetes only, according to a study published in the recent Journal of General Internal Medicine. Dementia is the progressive decline of thinking and reasoning abilities...
Obesity and depression are a two-way street (Reuters)
Source: Y! Health Depression News [2010.03.04]
Reuters - People who are obese are at increased risk of becoming depressed, and people who are depressed are at increased risk of becoming obese, Dutch researchers have found.
Published Studies Related to Parnate (Tranylcypromine)
Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant medication trials for depression: a STAR*D report. [2006.09]
CONCLUSIONS: Remission rates were modest for both the tranylcypromine group and the extended-release venlafaxine plus mirtazapine group, and the rates were not statistically different between groups. The lower side effect burden, lack of dietary restrictions, and ease of use of venlafaxine and mirtazapine suggest that this combination may be preferred over tranylcypromine for patients with highly treatment-resistant depression who have not benefited adequately from several prior treatments.
Safety of high-intensity treatment with the irreversible monoamine oxidase inhibitor tranylcypromine in patients with treatment-resistant depression. [2008.11]
INTRODUCTION: Because the irreversible monoamine oxidase inhibitor tranylcypromine (TCP) was introduced nearly 50 years ago, only few studies exist on today's clinical prescribing practice together with 2nd and 3rd generation psychotropic drugs. METHODS: We performed a practice-based observational study of patients with depression treated with TCP in two psychiatric departments in Berlin to assess side effects, effectiveness, comedication and acceptance of the low-tyramine diet.
Withdrawal from high-dose tranylcypromine. [2008.03]
A 34-year-old man with a history of multiple substance abuse (now abstinent for six years) became addicted to tranylcypromine, consuming up to 240 mg/day. After discontinuing the drug, he developed thrombocytopenia (52,000/ul) and delirium; there were no other anticholinergic signs.On hospital day 10, the patient was asymptomatic and left the hospital on his own recognizance.
Tranylcypromine vs. lamotrigine in the treatment of refractory bipolar depression: a failed but clinically useful study. [2007.05]
Objective: To compare the efficacy and tolerability of tranylcypromine vs.
Tranylcypromine: new perspectives on an "old" drug. [2006.08]
The irreversible inhibitor of monoamine oxidase, tranylcypromine, is a potent antidepressant, but its use is limited to special indications due to side effects and dietary restrictions... These findings implicate that the efficacy of tranylcypromine as an antidepressant may be due to its multiple actions within the human brain.
Clinical Trials Related to Parnate (Tranylcypromine)
Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions [Completed]
Tranylcypromine, Tranylcypromine Plus Dextroamphetamine and Tranylcypromine Plus Triiodothyronine as Treatment for Refractory Depression [Terminated]
This pilot study will assess the efficacy of several sequential pharmacological treatments
for patients with Refractory Depression.
Treatment of Orthostatic Hypotension in Autonomic Failure [Recruiting]
The autonomic nervous system serves multiple regulatory functions in the body, including the
regulation of blood pressure and heart rate, gut motility, sweating and sexual function.
There are several diseases characterized by abnormal function of the autonomic nervous
system. Medications can also alter autonomic function. Impairment of the autonomic nervous
system by diseases or drugs may lead to several symptoms, including blood pressure problems
(e. g., high blood pressure lying down and low blood pressure on standing), sweating
abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options
for these patients are limited. We propose to study patients autonomic failure and low blood
pressure upon standing and determine the cause of their disease by history and examination
and their response to autonomic testing which have already been standardized in our
laboratory. Based on their possible cause, we will tests different medications that may
alleviate their symptoms.
Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) [Completed]
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) [Completed]
STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in
outpatient settings. The primary purpose of this research study is to determine which
treatments work best if the first treatment with medication does not produce an acceptable
response. Participants will first receive citalopram, an SSRI medication; if symptoms remain
after 8-12 weeks of treatment, up to four other levels of treatment will be offered,
including cognitive therapy and other medications. There are no placebo treatments. Some
patients may require a combination of two or more treatments to obtain full benefit.
Participation could last from 15 to 27 months and involve up to 30 clinic visits.
Participants will be interviewed by telephone throughout the study about their symptoms,
daily functioning, treatment side effects, use of the health care system, and satisfaction
with treatment. There will be a one-year follow up for participants once their depression has
been successfully treated
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Page last updated: 2010-03-16
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