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)
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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)
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...
Treatment of atypical depression with cognitive therapy or phenelzine: a double-blind, placebo-controlled trial. [1999.05]
BACKGROUND: Patients with atypical depression are more likely to respond to monoamine oxidase inhibitors than to tricyclic antidepressants. They are frequently offered psychotherapy in the absence of controlled tests. There are no prospective, randomized, controlled trials, to our knowledge, of psychotherapy for atypical depression or of cognitive therapy compared with a monoamine oxidase inhibitor. Since there is only 1 placebo-controlled trial of cognitive therapy, this trial fills a gap in the literature on psychotherapy for depression... CONCLUSIONS: Cognitive therapy may offer an effective alternative to standard acute-phase treatment with a monoamine oxidase inhibitor for outpatients with major depressive disorder and atypical features.
Cognitive behavioral group therapy vs phenelzine therapy for social phobia: 12-week outcome. [1998.12]
BACKGROUND: This article presents results of the acute treatment phase of a 2-site study comparing cognitive behavioral group therapy (CBGT) and treatment with the monoamine oxidase inhibitor phenelzine sulfate for social phobia... CONCLUSIONS: After 12 weeks, both phenelzine therapy and CBGT were associated with marked positive response. Although phenelzine therapy was superior to CBGT on some measures, both were more efficacious than the control conditions. More extended cognitive behavioral treatment and the combination of modalities may enhance treatment effect.
Clinical Trials Related to Nardil (Phenelzine)
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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: 2007-10-18
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