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.)
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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Depression in Children
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Published Studies Related to Parnate (Tranylcypromine)
Double-blind comparison of 30 and 60 mg tranylcypromine daily in patients with panic disorder comorbid with social anxiety disorder. [2010.02.28]
Our objective was to explore the dose-response relationship in patients with panic disorder and social anxiety disorder comorbidity (DSM-IV). After 1 week of no-drug washout, 36 such patients were assigned to a double-blind controlled comparison of the effects of 30 mg and 60 mg of tranylcypromine, and were followed up for 12 weeks...
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.
[Tranylcypromine for chronic therapy-resistant agoraphobia with panic disorder and recurrent depressive disorder]. [2010.10]
OBJECTIVE: Tranylcypromine has been recommend as an option for therapy-resistant depressive and anxiety disorders. In this case report the effectiveness of this medication as a part of a combined therapy-program including pharmacological, behavioural and psychodynamic interventions could be demonstrated on an outpatient with a therapy-resistant depression and agoraphobia... CONCLUSION: After the failure of 13 antidepressant agents with considerable side effects, a one year sustained remission of depression as well as great improvement of agoraphobia could be achieved with tranylcypromine. In this situation, tranylcypromine showed itself, for the first time, to be a very effective and well tolerated antidepressant. (c) Georg Thieme Verlag KG Stuttgart . New York.
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.
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.
Tranylcypromine Treatment of Bipolar Depression [Recruiting]
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective
treatment of bipolar depression. New treatments are needed, as there is little evidence that
standard antidepressants are effective in treating this condition, and the two antipsychotic
medications that have indications for bipolar depression can cause substantial side effects.
This study will focus specifically on currently depressed outpatients having a bipolar
history for whom at least one standard antidepressant medication was ineffective. Patients
will be treated openly with tranylcypromine for 8-10 months, depending on treatment
PET Biomarkers in Treatment Resistant Depression [Recruiting]
The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A)
levels are elevated in patients with treatment-resistant major depression, and to explore
whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor
(MAOI) medication in this population.
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.
Reports of Suspected Parnate (Tranylcypromine) Side Effects
Feeling Abnormal (3),
Drug Ineffective (2),
Drug Interaction (2),
Weight Increased (2),
DRY Mouth (2),
Crying (2), more >>
Page last updated: 2014-08-23