Prescribing Information
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Complete research information
on fluoxetine.
Placebo-Controlled, Randomized Fluoxetine Clinical Trials
Editor: Research has proven that fluoxetine is an effective antidepressant medication. However there is little to suggest that fluoxetine is superior to any other antidepressant medication. In fact, current antidepressant medications are almost identical in their effectiveness (they only differ in safety, price and side-effects). In "head-to-head" comparisons of different antidepressant medications, you can usually predict the results by knowing which pharmaceutical company paid for the research. The main problem with fluoxetine is that it can cause sexual impairment in a significant minority of patients (as do most other antidepressant medications).
- Fluoxetine versus other types of pharmacotherapy for depression: Cochrane Reviews - Editor: The differences between antidepressant medications are only of borderline statistical significance.
- Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus: Cochrane Reviews - Editor: Fluoxetine produced a 5.1 kg weight loss at 24 to 26 weeks follow up.
- Predictors of Relapse in a Prospective Study of Fluoxetine Treatment of Major Depression - Editor: This study found that of individuals with Major Depression, treated with fluoxtine, lost their treatment benefit over time. At 12 weeks, 51% of the fluoxetine-treated patients were rated as "much improved", but at 52 weeks, only 28% were rated as "much improved". A similar loss of effectiveness over time has been documented for other antidepressant medications.
- A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression - Editor: In this study of individuals over 65, there was no significant difference in efficacy among placebo, venlafaxine, and fluoxetine for the treatment of depression. [Compare this negative result to the next study.]
- A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients - Editor: The 12-week responder rates in depressed, elderly outpatients, were 73% for sertraline and 71% for fluoxetine.
- Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder - Editor: Fluoxetine had limited efficacy in elderly dysthymic patients.
- Fluoxetine treatment for prevention of relapse of depression in children and adolescents: a double-blind, placebo-controlled study
- Editor: Fluoxetine, given for 32-weeks at 20 to 60 mg/day, was well tolerated and significantly delayed relapse of major depressive disorder symptoms in children and adolescents..
- Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial - Editor: After 12-weeks of treatment of adolescents with depression, fluoxetine was superior to Cognitive-Behavioral Therapy or placebo. Treatment with a combination of fluoxetine and CBT was superior to treatment with fluoxetine alone.
- When should a trial of fluoxetine for major depression be declared failed? - Editor: Nonresponse to fluoxetine should not be declared until 8 weeks of treatment have elapsed.
- Fluoxetine for the treatment of childhood anxiety disorders - Editor: Fluoxetine is useful and well tolerated for the acute treatment of anxious youths. However, a substantial group of treated patients remained symptomatic.
- Fluoxetine in children and adolescents with OCD: a placebo-controlled trial - Editor: Fluoxetine was well tolerated and effective for the treatment of child and adolescent OCD, but fluoxetine's full effect took more than 8 weeks to develop.
- A placebo-controlled, randomized trial of fluoxetine in the treatment of binge-eating disorder - Editor: In a 6-week, placebo-controlled, flexible-dose trial, fluoxetine was efficacious in reducing binge-eating frequency, weight, and severity of illness and was generally well tolerated in subjects with binge-eating disorder.
- Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial - Editor: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of Major Depression in child and adolescent outpatients.
- Premenstrual daily fluoxetine for premenstrual dysphoric disorder: a placebo-controlled, clinical trial using computerized diaries - Editor: Fluoxetine 20 mg daily from 14 days before next expected menses through the first full day of the menses significant decreases premenstrual syndrome.
- Treatment approaches to major depressive disorder relapse. Part 1: dose increase - Editor: Patients relapsing after initially responding to fluoxetine can benefit from an increase in fluoxetine dose.
- Fluoxetine in the prevention of depressive recurrences: a double-blind study - Editor: fluoxetine at 20 mg/day was effective and well tolerated for the prophylactic treatment of recurrent unipolar major depression.
- Fluoxetine treatment for obsessive-compulsive disorder in children and adolescents: a placebo-controlled clinical trial - Editor: Fluoxetine 20 to 60 mg daily was effective and well tolerated for treatment of OCD in this pediatric population.
- Short-term cotherapy with clonazepam and fluoxetine: anxiety, sleep disturbance and core symptoms of depression - Editor: Adding clonazepam 0.5mg - 1 mg/day to fluoxetine 20 mg/day was safe and accelerated response over 21 days of treatment for Major Depression.
- Weekly dosing of fluoxetine for the continuation phase of treatment of major depression: results of a placebo-controlled, randomized clinical trial - Editor: Fluoxetine given as a single 60 mg dose once a week was as effective as fluoxetine given 20 mg/day in a 7 week continuation trial.
- Interruption of selective serotonin reuptake inhibitor treatment. Double-blind, placebo-controlled trial - Editor: Stopping paroxetine (Paxil) suddenly causes significant withdrawal symptoms; whereas stopping fluoxetine (Prozac) suddenly does not result in significant withdrawal symptoms (because of its very long half-life).
- Fluoxetine versus amitriptyline in the treatment of major depression with associated anxiety (anxious depression): a double-blind comparison - Editor: "Fluoxetine was comparably efficacious to amitriptyline in the treatment of major depression with associated anxiety".
- Changes in weight during a 1-year trial of fluoxetine - Editor: Fluoxetine does not cause weight gain.
- A double-blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression - Editor: In this 8-week study, there was no difference in effectiveness between paroxetine, fluoxetine and placebo. To show a significant treatment effect, usually the study has to be longer than 8-weeks, and measure more objective outcomes like: rehospitalization rates, suicide rates, work absenteeism, and relapse rates. This study limited itself to just asking patients how they felt.
- Randomised, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome - Editor: Graded exercise produced improvements in functional work capacity and fatigue, while fluoxetine improved depression only.
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