Fluoxetine Clinical Trials and Studies

The efficacy of Prozac (Fluoxetine HCl) for the treatment of patients with depression (18 years of age) has been studied in 5- and 6-week placebo-controlled trials. Prozac (Fluoxetine HCl) was shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D). Fluoxetine HCl was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor.

Two 6-week controlled studies comparing Prozac (Fluoxetine HCl), 20 mg, and placebo have shown fluoxetine HCl, 20 mg daily, to be effective in the treatment of elderly patients (> 60 years of age) with depression. In these studies, Prozac (Fluoxetine HCl) produced 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 <7. Prozac (Fluoxetine HCl) was well tolerated and the rate of treatment discontinuations due to adverse events did not differ between Prozac (Fluoxetine HCl) (12%) and placebo (9%).

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 major depression by DSM-III-R criteria) by the end of an initial 12-week open treatment phase on Prozac (Fluoxetine HCl) 20 mg/day. These patients (N=298) were randomized to continuation on double-blind Prozac (Fluoxetine HCl) 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 major depression for 2 weeks or a modified HAMD-17 score of <14 for 3 weeks) was observed for patients taking fluoxetine HCl compared to those on placebo.

Obsessive Compulsive Disorder:

The effectiveness of Prozac (Fluoxetine HCl) for the treatment for obsessive compulsive disorder (OCD) was demonstrated in two 13-week, multicenter, parallel group studies (Studies 1 and 2) of adult outpatients who received fixed Prozac (Fluoxetine HCl) doses of 20, 40, or 60 mg/day (on a once a day schedule, in the morning) or placebo. Patients in both studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS, total score) ranging from 22 to 26. In Study 1, patients receiving Prozac (Fluoxetine HCl) experienced mean reductions of approximately 4 to 6 units on the YBOCS total score, compared to a 1-unit reduction for placebo patients. In Study 2, patients receiving Prozac (Fluoxetine HCl) experienced mean reductions of approximately 4 to 9 units on the YBOCS total score, compared to a 1-unit reduction for placebo patients. While there was no indication of a dose response relationship for effectiveness in Study 1, a dose response relationship was observed in Study 2, with numerically better responses in the 2 higher dose groups.

Bulimia Nervosa:

The effectiveness of Prozac (Fluoxetine HCl) 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 bulimia. Patients in the 8-week studies received either 20 mg/day or 60 mg/day of fluoxetine HCl or placebo in the morning. Patients in the 16-week study received a fixed fluoxetine HCl dose of 60 mg/day (once a day) or placebo. Patients in these 3 studies had moderate to severe bulimia with median binge-eating and vomiting frequencies ranging from 7 to 10 per week and 5 to 9 per week, respectively. In these 3 studies, fluoxetine HCl, 60 mg, but not 20 mg, was statistically significantly superior to placebo in reducing the number of binge-eating and vomiting episodes per week. The statistically significantly superior effect of 60 mg vs placebo was present as early as week 1 and persisted throughout each study. The Prozac (Fluoxetine HCl) related reduction in bulimic episodes appeared to be independent of baseline depression as assessed by the Hamilton Depression Rating Scale. In each of these 3 studies, the treatment effect, as measured by differences between fluoxetine HCl, 60 mg, and placebo on median reduction from baseline in frequency of bulimic behaviors at endpoint, ranged from 1 to 2 episodes per week for binge-eating and 2 to 4 episodes per week for vomiting. The size of the effect was related to baseline frequency, with greater reductions seen in patients with higher baseline frequencies. Although some patients achieved freedom from binge-eating and purging as a result of treatment, for the majority, the benefit was a partial reduction in the frequency of binge-eating and purging.

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Fluoxetine Clinical Trials and Studies

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