Status:
COMPLETED
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
Lead Sponsor:
Central South University
Conditions:
Weight Gain
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
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 therapie...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00451399
Start Date
October 1 2004
End Date
December 1 2006
Last Update
October 31 2007
Active Locations (1)
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1
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011