Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo .
However , low-certainty evidence suggests an increase in the risk for dizziness , drowsiness , fatigue , insomnia and nausea following fluoxetine treatment
BACKGROUND Fluoxetine is a serotonin reuptake inhibitor indicated for major depression .
It is also thought to affect weight control : this seems to happen through appetite changes result ing in decreased food intake and normalisation of unusual eating behaviours .
However , the benefit-risk ratio of this off-label medication is unclear .
OBJECTIVES To assess the effects of fluoxetine for overweight or obese adults .
The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases.
OBJECTIVE To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of venlafaxine extended release ( ER ) in preventing recurrence of depression . METHOD Out patients with recurrent unipolar depression ( DSM-IV criteria ; N = 1096 ) were r and omly assigned in a 3:1 ratio to 10 weeks of treatment with venlafaxine ER or fluoxetine . Responders ( 17-item Hamilton Rating Scale for Depression [ HAM-D(17 ) ] total score < or= 12 and > or= 50 % decrease from baseline ) entered a 6-month , double-blind continuation phase on the same medication . Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases . At the start of each maintenance phase , venlafaxine ER responders were r and omly assigned to receive double-blind treatment with venlafaxine ER or placebo , and fluoxetine responders were continued for each period . The second 12-month maintenance phase compared the time to recurrence of depression with venlafaxine ER ( 75 to 300 mg/day ) versus placebo as the primary efficacy measure . The primary definition of recurrence was a HAM-D(17 ) total score > 12 and < 50 % reduction from baseline ( acute phase ) at 2 consecutive visits or at the last valid visit prior to discontinuation . The time to recurrence was evaluated using Kaplan-Meier methods and compared between the venlafaxine ER and placebo groups using log-rank tests . Secondary outcome measures included rates of response and remission ( defined as HAM-D(17 ) < /= 7 ) . The study was conducted from December 2000 through July 2005 . RESULTS The cumulative probabilities of recurrence through 12 months in the venlafaxine ER ( N = 43 ) and placebo ( N = 40 ) groups were 8.0 % ( 95 % CI = 0.0 to 16.8 ) and 44.8 % ( 95 % CI = 27.6 to 62.0 ) , respectively ( p < .001 ) . At month 12 , using last-observation-carried-forward analysis , the rate of response or remission was significantly higher in the venlafaxine ER group ( 93 % ) than in the placebo group ( 63 % ; p = .002 ) . Overall discontinuation rates were 28 % and 63 % in the venlafaxine ER and placebo groups , respectively . Adverse events were the primary reason for discontinuation for 1 patient ( 2 % ) in the venlafax-ine ER group and 4 ( 10 % ) in the placebo group . An analysis of the combined maintenance phases , which compared the risk of recurrence over 24 months for patients assigned to venlafaxine ER ( N = 129 ) or placebo ( N = 129 ) for the first maintenance phase , showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group ( 47.3 % [ 95 % CI = 36.4 to 58.2 ] ) than for the venlafaxine ER group ( 28.5 % [ 95 % CI = 18.3 to 38.7 ] ; p = .005 ) . CONCLUSION In this study , an additional 12 months of maintenance therapy with venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to venlafaxine ER  after acute ( 10 weeks ) , continuation ( 6 months ) , and initial maintenance ( 12 months ) therapy . TRIAL REGISTRATION Clinical Trials.gov identifier NCT00046020 ( http://www . clinical trials.gov )
Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo .
However , low-certainty evidence suggests an increase in the risk for dizziness , drowsiness , fatigue , insomnia and nausea following fluoxetine treatment
BACKGROUND Fluoxetine is a serotonin reuptake inhibitor indicated for major depression .
It is also thought to affect weight control : this seems to happen through appetite changes result ing in decreased food intake and normalisation of unusual eating behaviours .
However , the benefit-risk ratio of this off-label medication is unclear .
OBJECTIVES To assess the effects of fluoxetine for overweight or obese adults .