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Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea

This study has been withdrawn prior to enrollment.
(Difficult to obtain informed consent)
Sponsor:
Information provided by (Responsible Party):
Jing-Ping Zhao, Central South University
ClinicalTrials.gov Identifier:
NCT01423487
First received: August 18, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Weight Gain
Amenorrhea
 Drug: Metformin
Other: Starch tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Central South University:

Primary Outcome Measures:
  • Change from Baseline in weight at 24 weeks [ Time Frame: baseline, 8 week, 16 week, 24 week ] [ Designated as safety issue: No ]
    The data will be presented


Secondary Outcome Measures:
  • Change from Baseline in menstruation at 24 weeks [ Time Frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week ] [ Designated as safety issue: No ]
    The data will be presented


Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: efficacy and safety
To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.
 Drug: Metformin
0.5g bid 26 weeks
Placebo Comparator: placebo comparator
To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.
 Other: Starch tablets
0.5g bid 26 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-40 years.
  2. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
  3. 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).
  4. treat with Risperidone.
  5. Never participate in a diet control nor in other weight loss programs, and have a normal Period.
  6. Written informed consents could be obtained from patients(or their Legal guardian).

Exclusion Criteria:

  1. Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
  2. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
  3. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
  4. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423487

Locations
China, Hunan
Mental Health Institute of The Second Xiangya Hospital
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Investigators
Study Chair: Jing-Ping Zhao, Dr., Ph.D. Mental Health Institute of The Second Xiangya Hospital, Central South University
  More Information

Publications:

Responsible Party: Jing-Ping Zhao, Professor,Deputy Director of Mental Health Institute of The Second Xiangya Hospital, Central South University
ClinicalTrials.gov Identifier: NCT01423487     History of Changes
Other Study ID Numbers: CSUXXEYYJYS-051
Study First Received: August 18, 2011
Last Updated: July 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Central South University:
Metformin
Risperidone
Prevention
weight gain
Amenorrhea

Additional relevant MeSH terms:
Amenorrhea
Weight Gain
Menstruation Disturbances
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms
Metformin
Risperidone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013