Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain

Overview[ - collapse ][ - ]

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.
ConditionWeight Gain
InterventionDrug: metformin
Behavioral: lifestyle intervention
PhasePhase 4
SponsorCentral South University
Responsible PartyCentral South University
ClinicalTrials.gov IdentifierNCT00451399
First ReceivedMarch 22, 2007
Last UpdatedOctober 30, 2007
Last verifiedOctober 2007

Tracking Information[ + expand ][ + ]

First Received DateMarch 22, 2007
Last Updated DateOctober 30, 2007
Start DateOctober 2004
Estimated Primary Completion DateDecember 2006
Current Primary Outcome Measuresbody weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
Official TitleEfficacy 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.
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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionWeight Gain
InterventionDrug: metformin
Behavioral: lifestyle intervention
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment128
Estimated Completion DateDecember 2006
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT00451399
Other Study ID NumbersJzhao
Has Data Monitoring CommitteeYes
Information Provided ByCentral South University
Study SponsorCentral South University
CollaboratorsNot Provided
Investigators Study Director: Jingping Zhao, MD Central South University
Verification DateOctober 2007

Locations[ + expand ][ + ]

Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011