drugset / Trial / NCT00451399

Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain

NCT00451399 ↗

Phase 4 Completed 128 enrolled Central South University
RandomizedFactorialDouble-blindTreatment

Summary

Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.

Timeline

Start
2004-10
Primary completion
—
Completion
2006-12

Outcome

Met primary endpoint

paper The lifestyle-plus-metformin treatment was significantly superior to metformin alone and to lifestyle plus placebo for weight, BMI, and waist circumference reduction. PMID 18182600 ↗

paper CONCLUSIONS: Lifestyle intervention and metformin alone and in combination demonstrated efficacy for antipsychotic-induced weight gain. PMID 18182600 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 750 mg —

Indications

No indication recorded.