Efficacy and safety of weekly treatment with enteric-coated fluoxetine in patients with major depressive disorder.

A new formulation of fluoxetine has been developed that is intended to allow for weekly dosing during the long-term treatment of depression. This 90-mg enteric-coated formulation of fluoxetine was compared with 20-mg daily fluoxetine and placebo during a 25-week continuation treatment period in a study of 501 depressed patients who had responded to acute treatment with 20-mg daily fluoxetine. Both active drug formulations were statistically superior to placebo in maintaining the acute treatment response and prolonging the time to relapse. Patients with high baseline anxiety responded similarly to the 90-mg weekly and 20-mg daily fluoxetine treatments. In addition, the 90-mg weekly fluoxetine dose had a safety profile similar to that of both daily fluoxetine dosing and placebo. The once-weekly fluoxetine formulation provides an effective and tolerable treatment option for patients requiring extended depression therapy.

RCT Entities:   Population Interventions Outcomes