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Sponsored by: |
Central South University |
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Information provided by: | Central South University |
ClinicalTrials.gov Identifier: | NCT00451399 |
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.
Condition | Intervention | Phase |
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Weight Gain |
Drug: metformin Behavioral: lifestyle intervention |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison |
Estimated Enrollment: | 128 |
Study Start Date: | October 2004 |
Study Completion Date: | December 2006 |
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.128 patients were randomized to one of four 12-week individual treatments: metformin (750mg/day), placebo, lifestyle intervention plus metformin (750mg/day) or lifestyle intervention plus placebo. Medications were provided in double-blind fashion.The assessments include body weight, body mass index, waist circumference, fasting glucose, fasting insulin and insulin resistance index.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Hunan | |
Institute of Mental Health of The Second Xiangya Hospital, Central South University | |
Changsha, Hunan, China, 410011 |
Study Director: | Jingping Zhao, MD | Central South University |
Study ID Numbers: | Jzhao |
Study First Received: | March 22, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00451399 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Weight gain antipsychotic lifestyle interventions metformin antipsychotic-induced weight gain. |
Body Weight Signs and Symptoms Tranquilizing Agents Hypoglycemic Agents Metformin |
Psychotropic Drugs Body Weight Changes Central Nervous System Depressants Antipsychotic Agents Weight Gain |
Tranquilizing Agents Metformin Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Weight Gain Antipsychotic Agents |
Pharmacologic Actions Body Weight Signs and Symptoms Hypoglycemic Agents Therapeutic Uses Body Weight Changes Central Nervous System Agents |