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

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ClinicalTrials.gov Identifier: NCT01423487
Recruitment Status : Withdrawn (Difficult to obtain informed consent)
First Posted : August 26, 2011
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Jing-Ping Zhao, Central South University

Brief Summary:
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 or disease Intervention/treatment Phase
Weight Gain Amenorrhea Drug: Metformin Other: Starch tablets Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

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.
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



Primary Outcome Measures :
  1. Change from Baseline in weight at 24 weeks [ Time Frame: baseline, 8 week, 16 week, 24 week ]
    The data will be presented


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by Jing-Ping Zhao, Central South University:
Metformin
Risperidone
Prevention
weight gain
Amenorrhea

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