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

Primary Purpose

Weight Gain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
metformin
lifestyle intervention
Sponsored by
Central South University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain focused on measuring Weight gain, antipsychotic, lifestyle interventions, metformin, antipsychotic-induced weight gain.

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Mental Health of The Second Xiangya Hospital, Central South University

Outcomes

Primary Outcome Measures

body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index

Secondary Outcome Measures

Full Information

First Posted
March 22, 2007
Last Updated
October 30, 2007
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT00451399
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
Weight gain, antipsychotic, lifestyle interventions, metformin, antipsychotic-induced weight gain.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Primary Outcome Measure Information:
Title
body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingping Zhao, MD
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Mental Health of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30542300
Citation
Kang D, Jing Z, Li R, Hei G, Shao T, Li L, Sun M, Yang Y, Wang Y, Wang X, Long Y, Huang X, Wu R. Effect of Betahistine and Metformin on Antipsychotic-Induced Weight Gain: An Analysis of Two Clinical Trials. Front Psychiatry. 2018 Nov 27;9:620. doi: 10.3389/fpsyt.2018.00620. eCollection 2018.
Results Reference
derived
PubMed Identifier
18182600
Citation
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. doi: 10.1001/jama.2007.56-b.
Results Reference
derived

Learn more about this trial

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

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