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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain | ||||
| Official Title † | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison | ||||
| Brief 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Weight Gain | ||||
| Intervention † | Drug: metformin Behavioral: lifestyle intervention |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 128 | ||||
| Start Date † | October 2004 | ||||
| Completion Date | December 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | China | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00451399 | ||||
| Organization ID | Jzhao | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Central South University | ||||
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| Investigators † |
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| Information Provided By | Central South University | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | March 22, 2007 | ||||
| Last Updated Date | October 30, 2007 | ||||