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| Tracking Information | |||||
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| First Received Date ICMJE | March 22, 2007 | ||||
| Last Updated Date | October 30, 2007 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00451399 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Weight Gain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 128 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00451399 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Jzhao | ||||
| Study Sponsor ICMJE | Central South University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Central South University | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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