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)
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Medscape Medical News
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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.
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.
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.
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.
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 >>
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Page last updated: 2015-01-23
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