- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423487
Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea
July 31, 2012 updated by: Jing-Ping Zhao, Central South University
Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea:a 24-week, Randomized, Placebo-controlled, Double-blind, Fixed-dose Study
Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics.
An our study, which will be published, also found that Metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period.
So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Mental Health Institute of The Second Xiangya Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age 18-40 years.
- diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
- At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
- treat with Risperidone.
- Never participate in a diet control nor in other weight loss programs, and have a normal Period.
- Written informed consents could be obtained from patients(or their Legal guardian).
Exclusion Criteria:
- Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
- Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
- At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
- Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: efficacy and safety
To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
|
0.5g bid 26 weeks
|
Placebo Comparator: placebo comparator
To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.
|
0.5g bid 26 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in weight at 24 weeks
Time Frame: baseline, 8 week, 16 week, 24 week
|
The data will be presented
|
baseline, 8 week, 16 week, 24 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in menstruation at 24 weeks
Time Frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
|
The data will be presented
|
baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jing-Ping Zhao, Dr., Ph.D., Mental Health Institute of The Second Xiangya Hospital, Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
February 1, 2013
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
August 18, 2011
First Submitted That Met QC Criteria
August 25, 2011
First Posted (Estimate)
August 26, 2011
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
July 31, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSUXXEYYJYS-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amenorrhea
-
Mayo ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingHypothalamic AmenorrheaUnited States
-
University of Colorado, Colorado SpringsRecruitingAmenorrhea SecondaryUnited States
-
Catholic University of the Sacred HeartUnknownHypothalamic AmenorrheaItaly
-
University of California, DavisCompletedBreast Feeding | Milk Expression, Breast | Amenorrhea, PostpartumUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Imperial College LondonUniversity College, LondonRecruiting
-
TherapeuticsMDTerminated
-
Solvay PharmaceuticalsCompletedSecondary AmenorrheaUnited States
-
Massachusetts General HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedExercise-related AmenorrheaUnited States
-
University Hospital, LilleRecruitingChemotherapy-Induced AmenorrheaFrance
Clinical Trials on Metformin
-
Anji PharmaSuspendedDiabetes Mellitus, Type 2Spain, United States, Canada, Hungary, Brazil, Czechia, Poland, Bulgaria
-
ShionogiCompleted
-
NuSirt BiopharmaCompletedType 2 Diabetes MellitusUnited States
-
Charles University, Czech RepublicCompleted
-
Bristol-Myers SquibbCompletedType 2 Diabetes MellitusSouth Africa, United States, Canada, Puerto Rico, Hungary, Germany, Czechia, Poland, Romania, United Kingdom
-
Woman'sPfizer; American Cancer Society, Inc.; Our Lady of the Lake Regional Medical...WithdrawnInsulin Resistance | Breast Cancer Stage | Racial BiasUnited States
-
Hoffmann-La RocheCompletedDiabetes Mellitus Type 2United States, Mexico, Argentina
-
Hadassah Medical OrganizationWithdrawn
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
University Hospital, Basel, SwitzerlandCompletedBecker's Muscular Dystrophy (BMD)Switzerland