PROZAC Rx

Obsessive Compulsive Disorder

Adult

• In two 13-week, multicenter, parallel group studies (Study 1 and 2), the efficacy of Prozac was evaluated in adult outpatients with moderate to severe OCD. Patients received fixed doses of Prozac 20, 40, or 60mg/day (on a once-a-day schedule, in the morning) or placebo.

• In Study 1, patients treated with Prozac achieved mean reductions of approximately 4 to 6 units on the Yale-Brown Obsessive Compulsive Scale (YBOCS) total score compared with a 1-unit reduction for placebo patients.

• In Study 2, patients treated with Prozac achieved mean reductions of approximately 4 to 9 units on the YBOCS total score compared with a 1-unit reduction for placebo patients. 

Pediatric (Children and Adolescents)

• In one 13-week clinical trial, 103 pediatric patients received Prozac 10mg/day for 2 weeks followed by 20mg/day for 2 weeks. Treatment with Prozac achieved a statistically significantly greater mean change from baseline to endpoint than did placebo as measured by the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS). 

Panic Disorder

Two double-blind, randomized, placebo-controlled, multicenter studies evaluated the effectiveness of Prozac for the treatment of adult outpatients who had a primary diagnosis of panic disorder (DSM-IV), with or without agoraphobia. 

In Study 1 (N=180 randomized), Prozac was initiated at 10 mg/day for the first week, after which patients were dosed in the range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of Prozac-treated patients were free from panic attacks at endpoint than placebo-treated patients, 42% versus 28%, respectively. 

In Study 2 (N=214 randomized), Prozac was initiated at 10 mg/day for the first week, after which patients were dosed in a range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of Prozac-treated patients were free from panic attacks at endpoint than placebo-treated patients, 62% versus 44%, respectively.

Major Depressive Disorder

Daily Dosing – Adult

• The efficacy of Prozac was studied in 5- and 6-week placebo-controlled trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder (MDD). Prozac was shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D). PROZAC was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor.

• In two 6-week controlled studies, the efficacy of Prozac 20mg was compared to placebo in 671 elderly patients with MDD. Treatment with Prozac 20mg achieved a significantly higher rate of response and remission as defined, respectively, by a 50% decrease in the HAM-D score and a total endpoint HAM-D score of ≤8.

Daily Dosing – Pediatric (children and adolescents)

• In two  8- to 9-week placebo-controlled trials, the efficacy of Prozac 20mg/day was evaluated in children and adolescents who were depressed and diagnosed corresponding most closely to the DSM-III-R or DSM-IV category of MDD. Both studies showed that Prozac achieved a statistically significantly greater mean change on the Childhood Depression Rating Scale-Revised (CDRS-R) total score from baseline to endpoint than did placebo.

Maintenance Treatment

• A study was conducted involving depressed outpatients who had responded (modified HAMD-17 score of ≤7 during each of the last 3 weeks of open-label treatment and absence of MDD by DSM-III-R criteria) by the end of an initial 12-week open-treatment phase on Prozac 20 mg/day. These patients (N=298) were randomized to continuation on double-blind Prozac 20 mg/day or placebo. At 38 weeks (50 weeks total), a statistically significantly lower relapse rate (defined as symptoms sufficient to meet a diagnosis of MDD for 2 weeks or a modified HAMD-17 score of ≥14 for 3 weeks) was observed for patients taking Prozac compared with those on placebo. 

• An additional maintenance study was conducted involving adult outpatients meeting DSM-IV criteria for MDD who had responded (defined as having a modified HAMD-17 score of ≤9, a CGI-Severity rating of ≤2, and no longer meeting criteria for Major Depressive Disorder) for 3 consecutive weeks at the end of 13 weeks of open-label treatment with Prozac 20 mg once daily. These patients were randomized to double-blind, once-weekly continuation treatment with fluoxetine delayed-release capsules 90 mg once weekly, Prozac 20 mg once daily, or placebo. Prozac 20 mg once daily demonstrated superior efficacy (having a significantly longer time to relapse of depressive symptoms) compared with placebo for a period of 25 weeks.

Bulimia Nervosa

The efficacy of Prozac for the treatment of bulimia was demonstrated in two 8-week and one 16-week, multicenter, parallel group studies of adult outpatients meeting DSM-III-R criteria for moderate to severe bulimia. In the 8-week studies, patients received either 20 or 60 mg/day of Prozac or placebo in the morning. In the 16-week study, patients received a fixed dose of Prozac 60 mg/day.

• Results from the 3 studies showed that treatment with Prozac 60 mg was statistically significantly superior to placebo in reducing the number of binge-eating and vomiting episodes per week. This effect was present as early as Week 1 and persisted throughout each study. The reduction in the frequency of bulimic behaviors ranged from 1 to 2 episodes per week for binge-eating and 2 to 4 episodes per week for vomiting.

In a longer-term trial, 150 patients meeting DSM-IV criteria for Bulimia Nervosa, purging subtype, who had responded during a single-blind, 8-week acute treatment phase with Prozac 60 mg/day, were randomized to continuation of Prozac 60 mg/day or placebo, for up to 52 weeks of observation for relapse. Response during the single-blind phase was defined by having achieved at least a 50% decrease in vomiting frequency compared with baseline. Patients receiving continued Prozac 60 mg/day experienced a significantly longer time to relapse over the subsequent 52 weeks compared with those receiving placebo.