Fluvoxamine open-label treatment of adolescent inpatients with obsessive-compulsive disorder or depression

Abstract

Objective: Fluvoxamine, a monocyclic, specific serotonin uptake inhibitor with demonstrated efficacy in obsessive-compulsive disorder (OCD) and depression in adults, is marketed in more than 30 countries worldwide, including Israel. In the United States, where fluvoxamine is available only on an investigational basis, marketing appears imminent. This study evaluates the safety and efficacy of fluvoxamine in adolescents.

Method: In an 8-week, open-label trial of fluvoxamine, 20 adolescent inpatients, ages 13 to 18 years, were treated for OCD (n = 14) or major depressive disorder (MDD)(n = 6) with daily doses ranging from 100 to 300 mg. Target symptoms were rated at regular intervals with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS); Suicide Potential Scales (SPS); Beck Depression Inventory (BDI); the Overt Aggression Scale (OAS); and the Children's Global Adjustment Scale (CGAS).

Results: Fluvoxamine proved relatively safe and was especially effective in the patients with OCD; mean Y-BOCS scores decreased significantly (p < .0001) from 28.0 to 19.8 on medication. Although fluvoxamine also appeared effective in decreasing depression and bulimic symptoms, its impact on impulsive, suicidal, and anorectic symptoms was less clear. The commonest side effects (n > or = 3) were dermatitis, insomnia, hyperactivity, excitement, anxiety, tremor, and nausea. Fluvoxamine was discontinued in four patients because of side effects; the most serious side effect occurred in two debilitated anorexic patients, of whom one became delirious and the other developed hallucinations.

Conclusion: Preliminary evidence suggests that short-term treatment of adolescents with fluvoxamine is relatively safe and may be effective for OCD and some affective spectrum symptoms.