Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451399
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2007-03-22
Brief Title:
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain a Randomized Double-Blind Placebo- Controlled Comparison
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 intervention128 patients were randomized to one of four 12-week individual treatments metformin 750mgday placebo lifestyle intervention plus metformin 750mgday or lifestyle intervention plus placebo Medications were provided in double-blind fashionThe assessments include body weight body mass index waist circumference fasting glucose fasting insulin and insulin resistance index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None