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Nardil (Phenelzine 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 Nardil 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. Nardil is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

 

NARDIL SUMMARY

NARDIL®
(Phenelzine Sulfate Tablets, USP)

NARDIL® (phenelzine sulfate) is a potent inhibitor of monoamine oxidase (MAO). Phenelzine sulfate is a hydrazine derivative.

Nardil (Phenelzine) is indicated for the following:

NARDIL has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features.

NARDIL should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.


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NEWS HIGHLIGHTS

Published Studies Related to Nardil (Phenelzine)

A placebo-controlled trial of phenelzine, cognitive behavioral group therapy, and their combination for social anxiety disorder. [2010.03]
CONTEXT: Medication and cognitive behavioral treatment are the best-established treatments for social anxiety disorder, yet many individuals remain symptomatic after treatment. OBJECTIVE: To determine whether combined medication and cognitive behavioral treatment is superior to either monotherapy or pill placebo... CONCLUSION: Combined phenelzine and CBGT treatment is superior to either treatment alone and to placebo on dimensional measures and on rates of response and remission.

A placebo-controlled trial of phenelzine, cognitive behavioral group therapy, and their combination for social anxiety disorder. [2010]
treatment is superior to either monotherapy or pill placebo... CONCLUSION: Combined phenelzine and CBGT treatment is superior to either

Lithium augmentation compared with phenelzine in treatment-resistant depression in the elderly: an open, randomized, controlled trial. [2007.08]
CONCLUSION: Lithium was more effective than phenelzine in elderly patients with treatment-resistant major depressive disorder, while tolerance of both treatments was remarkably good in this group of elderly inpatients with many comorbid medical disorders. CLINICAL TRIALS REGISTRATION: Controlled-trials.com identifier is RCTN93105957.

Efficacy and tolerability of tranylcypromine versus phenelzine: a double-blind study in antidepressant-refractory depressed inpatients. [2004.11]
CONCLUSION: No difference in efficacy was observed between both monoamine oxidase inhibitors in a sample of patients with severe antidepressant-refractory depression. Phenelzine appears to be a suitable alternative to tranylcypromine.

Rapid tryptophan depletion reverses phenelzine-induced suppression of REM sleep. [2003.03]
Treatment with the monoamine oxidase inhibitor phenelzine completely suppressed rapid eye movement (REM) sleep in five depressed patients. Hypothesizing that increased serotonergic neurotransmission eliminated REM sleep, we administered a tryptophan-free amino acid drink (TFD) known to reduce plasma tryptophan and brain levels of serotonin...

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Clinical Trials Related to Nardil (Phenelzine)

Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer [Recruiting]
This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.

Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel [Recruiting]
This phase II trial is studying how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer with progressive disease after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.

Detecting Central and Peripheral Biomarkers in MDD [Recruiting]
The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution volume (VT), after phenelzine treatment and if so to what extent.

Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Recruiting]
Reduction of volume of the hippocampus has been associated with major depression in many studies. It has been suggested that antidepressants may protect against hippocampus volume loss in humans associated with multiple episodes of depression and may also reverse the reduction of volume caused by the depression. In addition, genetic markers for serotonin are implicated with depression, and may be an indication of reduced response to antidepressant treatments.

This study aims to enroll patients who are defined as having treatment resistant depression (no remission after at least 2 treatments trials with an antidepressant). They will receive an MRI scan at the initial visit and either 6 months after sustained remission or 12 months after they enter the study for non-remitters. They will also be asked to give a blood sample for genotyping. They will be matched by age and handedness to healthy volunteers with no personal history of depression who will also receive an MRI scan and genotyping.

The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It is anticipated that subjects will initially have smaller hippocampal volume but of those who sustain remission, there will be a small increase in hippocampal volume. It is also anticipated that specific genetic markers will be related to individuals response to antidepressant treatments.

more trials >>

Reports of Suspected Nardil (Phenelzine) Side Effects

Drug Ineffective (31)Depression (12)Weight Increased (11)Oedema Peripheral (11)Feeling Abnormal (11)Nausea (10)Headache (9)Thrombosis (8)Weight Decreased (8)Psoriasis (8)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Nardil has an overall score of 9. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
 

Nardil review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression (atypical)
Dosage & duration:   75mg taken 15mg 5 times per day for the period of 18 months
Other conditions:   anxiety
Other drugs taken:   lamictal 150mg per day
  
Reported Results
Benefits:   A dramatic decrease in the level of depression and a great increase in a feeling of well-being and hope for the future. There were also considerable cognitive benefits: thought processes speeded up, memory became stronger and intellectual creativity increased. Also the constant fatigue that accompanied the depression decreased and this made possible an exercise program that increased energy and enjoyment of strenuous activities. In addition my general and social anxiety decreased dramatically.
Side effects:   The most troublesome side effect was faintness upon rising quickly from a seated (or horizontal) position. On one occasion I lost consciousness and fell. However, this side effect went away after three months or so. There was also some decrease in sexual desire, but this side effect also lessened over time. A side effect that seems to be permanent is lower blood pressure, but this is actually a benefit for most people. I've been told that some people take MAOI's solely to decrease their blood pressure.
Comments:   It takes some time to build up to a clinical dosage. As I recall, my doctor had me take 15mg for a weak, 30mg for two weeks, 45mg for two weeks until I had built up to 75mg. I did not begin to feel the antidepressant effect until I reached 45mg. When I reached 60mg the antidepressant effect had kicked in fully and I even experienced a period (two or three weeks) of a mild euphoria, which I have been told is fairly typical. My doctor thought that a slow buildup of the drug in my system was the most effective treatment. He also had me taking Lamictal (150mg per day), which he thought might spark a stronger reaction to Nardil. There are also some diet restrictions: no aged cheeses and no aged meats. Also, some cold medications must be avoided.

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Page last updated: 2013-02-10

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