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Parnate (Tranylcypromine Sulfate) - Summary

 
 



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.)

 

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.

For the treatment of Major Depressive Episode Without Melancholia.

PARNATE 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.

SUMMARY OF CONTRAINDICATIONS

PARNATE should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative, or anesthetic drugs; bupropion HCl; buspirone HCl; dextromethorphan; cheese or other foods with a high tyramine content; or excessive quantities of caffeine.

PARNATE should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache.

(For complete discussion of contraindications and warnings, see below.)


See all Parnate indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Parnate (Tranylcypromine)

Depression Plus BP Extremes May Increase CV Event Risks
Source: theheart.org | Medscape Cardiology Headlines [2015.08.29]
Both high and low systolic BP in patients with depressive symptoms were predictors of poor outcomes. However, associations with diastolic BP were another matter.
Heartwire from Medscape

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Goth Teens: Special Risk Seen for Depression, Self-Harming (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- More identification with goth culture increases risk

About 10 percent of mothers experienced depression 2 years after Hurricane Katrina, study shows
Source: Aid / Disasters News From Medical News Today [2015.08.28]
About 10 percent of mothers experienced chronic, persistent depressive symptoms two years after Hurricane Katrina slammed into the Gulf Coast, killing more than 1,800 people, displacing hundreds of...

Goth teens could be more vulnerable to depression and self-harm
Source: Depression News From Medical News Today [2015.08.28]
Young people who identify with the goth subculture might be at increased risk of depression and self-harm, according to new research published in The Lancet Psychiatry journal.

more news >>

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.

more studies >>

Clinical Trials Related to Parnate (Tranylcypromine)

Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions [Completed]

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 response.

Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression [Terminated]
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.

Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible [Recruiting]
Longterm disease-free survival (DFS) of older patients with acute myeloid leukemia (AML) remains poor. The vast majority of AML patients relapses within two years after start of therapy1,2. In Acute Promyelocytic Leukemia (APL, AML M3), all-trans-retinoic-acid (ATRA; Tretinoin) induces differentiation and subsequently clinical remission. So far effective differentiation therapy does not exist in other AML subtypes. Recent preclinical data suggest that the combinatorial use of ATRA and tranylcypromine (TCP), an irreversible Monoamine-Oxidase (MAO) and Lysin-specific demethylase (LSD) inhibitor that also inhibits LSD1 (a histone H3 Lysine 4 demethylase), induces leukemia cell differentiation and leukemic stem cell exhaustion in vitro and in vivo in non-APL AML subtypes. In this Phase I/II study the investigators will explore the feasibility, safety, as well as efficacy and of Tretinoin/TCP treatment in patients with relapsed or refractory AML or in patients with AML who are not eligible for intensive treatment. Patients will be treated with daily increasing doses of TCP (initially 10 mg/day, then +10 mg each day up to 80mg/d). After 7 days, ATRA will be added at a fixed dose (45 mg/sqm/day). Overall, 16 evaluable patients are going to be treated. The primary endpoint is the fraction of patients that achieve CR, CRp( complete response with incomplete recovery of platelets), CRi (complete response with incomplete recovery of granulocytes) and PR. Secondary endpoints are tolerability, safety as well as progression-free survival and overall survival. Serum levels of TCP will be regularly analyzed. Pharmacodynamic analyses will be performed with analyses of the inhibition of LSD1 by TCP. Further analyses will address the changes in Histone H3 lysine 4 tri demethylase (H3K4me3) levels in AML blasts and the differentiation status of AML blasts. Taken together, this Phase I/II study will analyze feasibility, pharmacodynamics and effectivity of ATRA and TCP as differentiation therapy in AML.

Phase 1 Study of TCP-ATRA for Adult Patients With AML and MDS [Recruiting]
Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.

more trials >>

Reports of Suspected Parnate (Tranylcypromine) Side Effects

Feeling Abnormal (3)Drug Ineffective (2)Drug Interaction (2)Somnolence (2)Hunger (2)Weight Increased (2)DRY Mouth (2)Sedation (2)Depression (2)Crying (2)more >>


Page last updated: 2015-08-29

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