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

Sponsor

Central South University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01423487

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from Baseline in weight at 24 weeks [baseline, 8 week, 16 week, 24 week]
The data will be presented

Secondary Outcome Measures

Change from Baseline in menstruation at 24 weeks [baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week]
The data will be presented

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.