Nefazodone for Panic
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Synopsis: This double-blind, placebo-controlled trial found that nefazodone (Serzone) was effective and well tolerated for the treatment of panic disorder.
Source: Cassano G, et al. A multicenter, double-blind comparison of nefazodone and placebo in the treatment of panic disorder. New Clinical Drug Evaluation Unit Program, 39th Annual Meeting, June 1-4, 1999, Boca Raton, FL.
Nefazodone (serzone) is a combined serotonin norepinephrine reuptake inhibitor, with post-synaptic 5HT2 antagonism. Nefazodone is currently indicated in the United States for treatment of depression. As with selective serotonin reuptake inhibitors (SSRIs), nefazodone may have a spectrum of efficacy that extends beyond the treatment of depression. This 12-week, double-blind, flexible dose study of outpatients with DSM-IV diagnosed panic disorder was conducted at 23 European centers. Patients who had at least two panic attacks during the two-week placebo run were randomized to either nefazodone or placebo. Nefazodone was initiated at 50 mg bid followed by a flexible-dose titration, with an allowable dose range of 100-600 mg per day. A total of 274 patients were randomized. The primary efficacy rating was based on the number of full panic attacks within two weeks as determined at the 10 week end point. At end point, nefazodone treated patients exhibited significantly (P < 0.05) greater improvement than the control group. Similar results were evident on other outcome measures, such as mean reduction in the number of panic attacks from baseline, and the number of patients with a 50% reduction in panic attacks from baseline. At end point, the mean nefazodone dose was 453 mg per day. Nefazodone was well tolerated, with only 4% discontinuation for adverse events compared to 7% of the placebo patients. Common adverse events in the nefazodone-treated patients were dizziness and somnolence, which is consistent with the use of this drug in the treatment of depression.
Comment by Lauren B. Marangell, MD
As with most placebo-controlled trials for a new indication, this study was supported by Bristol-Myers Squibb, manufacturer of nefazodone. The overall design was appropriate and the study used an adequate sample size. Other medications that are effective for the treatment of panic disorder are the tricyclic antidepressants, particularly imipramine, SSRIs, monoamine oxidase inhibitors, and benzodiazepines. The tricyclic antidepressants were previously first-line agents but due to an increased side-effect burden and lethality in overdose, these agents are now second-line to the SSRIs. The SSRIs are effective in many patients but are sometimes not tolerated due to either acute or longer-term side effects (i.e., sexual dysfunction). Monoamine oxidase inhibitors are traditionally the therapy of last resort, given the risk of potentially lethal drug and food interactions. Benzodiazepines are often appropriate for acute use, and are sometimes recommended while the patient is being stabilized on an antidepressant for longer-term control of panic symptoms. Benzodiazepines are less desirable for long-term use. Benzodiazepines should be avoided in patients with substance abuse problems. Given the possible limitations of currently available treatments in at least some patients, the current data, particularly if replicated, will offer an additional therapeutic alternative for patients with panic disorder.
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