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Citation
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Beasley CM, Dornseif BE, Bosomworth JC, Sayler ME, Rampey AH, Heiligenstein JH, Thompson VL, Murphy DJ, Masica DN. Int. Clin. Psychopharmacol. 1992; 6: 35-57. |
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Abstract
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OBJECTIVE -- A comprehensive meta-analysis of clinical trial data was performed to assess the possible association of fluoxetine and suieidality (suicidal acts and ideation). Design -- Retrospective analysis of pooled data from 17 double blind clinical trials in patients with major depressive disorder comparing fluoxetine In = 1765) with a tricyclic antidepressant in = 731) or placebo In = 569), or both. Mum outcome measures -- Multiple data sources were searched to identify patients with suicidal acts. Suicidal ideation was assessed with item 3 of the Hamilton depression rating scale, which systematically rates suieidality. Emergence of substantial suicidal ideation was defined as a change in the rating ot this item from 0 or 1 at baseline to 3 or 4 during double blind treatment; worsening was defined as any increase from baseline; improvement was defined as a decrease from baseline at the last visit during the treatment.
RESULTS -- Suicidal acts did not differ significantly in comparisons of fluoxetine with placebo (0.291 vs 0.2%. p = 0.494, Mantel-Haenszel adjusted incidence difference) and with tricyclic antidepressants (0.79% vs 0.4%, p = 0.419). The pooled incidence of suicidal acts was 0.3% for fluoxetine. 0.2% for placebo, and 0.47% for tricyclic antidepressants, and fluoxetine did not differ significantly from either placebo Ip = 0.533, Pearson's χ2) or tricyclic antidepressants Ip = 0.789). Suicidal ideation emerged marginally significantly less often with fluoxetine than with placebo (0.9% vs 2.6%, p = 0.094) and numerically less often than with tricyclic antidepressants (1.77% vs 3.6%, p=0.102). The pooled incidence of emergence of substantial suicidal ideation was 1.2% for fluoxetine, 2.6% for placebo, and 3.6% for tricyclic antidepressants. The incidence was significantly lower with fluoxetine than with placebo Ip = 0.042) and tricyclic antidepressants ip = 0.001). Any degree of worsening of suicidal ideation was similar with fluoxetine and placebo (15.47% vs 17.9%, p = 0.196) and with fluoxetine and tricyclic antidepressants (15.6% vs 16.3%, p = 0.793). The pooled incidence of worsening of suicidal ideation was 15.3% for fluoxetine, 17.9% for placebo, and 16.3% for tricyclic antidepressants. The incidence did not differ cyclic anlideprcssants (72.5% vs 69.8%, p=0.294). The pooled incidence of improvement of suicidal ideation was 72.2% for fluoxetine, 54.8% for placebo, and 69.8% for tricyclic antidepressants. The incidence with fluoxetine was significantly greater than with placebo (p < 0.001) and did not differ from that with tricyclic antidepressants (p = 0.296).
CONCLUSION--Data from these trials do riot show that fluoxetine is associated with an increased risk of suicidal acts or emergence of substantial suicidal thoughts among depressed patients. © 1992 Rapid Communications of Oxford Ltd.
Language: en |