Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
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Purpose
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 |
|---|---|---|
|
Weight Gain |
Drug: metformin Behavioral: lifestyle intervention |
Phase 4 |
Central South University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison |
- body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia27.
- Participants were required to get weight gain more than 10% of their predrug body weight during less than 12 months of treatment with a targeted antipsychotic agent- clozapine, olanzapine, risperidone or sulpiride.
- The duration of illness for all participants was less than 12 months.
- Participants could be taking only one antipsychotic, whose dose had not changed by changed by more than 25% over the past 3 months.
- All patients were stable outpatient.
- The total score of Positive and Negative Syndrome Scale (PANSS) for all patients could be ≤60.
- All participants were ensured that they could be carefully taken care of by one of their parents or guardians during the trial.
Exclusion Criteria:
- Participants were excluded from the study if they had evidence of liver or renal diseases, pregnant or lactating women, cardiovascular diseases, hypertension or diabetes mellitus, specific systemic diseases, or conditions that limited their ability to perform the lifestyle modifications, such as arthritis, pulmonary diseases, neurological or dietary restrictions.
Contacts and Locations| 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 |
More Information
No publications provided by Central South University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00451399 History of Changes |
| Other Study ID Numbers: | Jzhao |
| Study First Received: | March 22, 2007 |
| Last Updated: | October 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Central South University:
|
Weight gain antipsychotic lifestyle interventions metformin antipsychotic-induced weight gain. |
Additional relevant MeSH terms:
|
Weight Gain Body Weight Changes Body Weight Signs and Symptoms Metformin Antipsychotic Agents Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013