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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01423487

Enrollment

Registered

2011-08-26

Start date

2011-08-31

Completion date

2013-08-31

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea, Weight Gain

Keywords

Metformin, Risperidone, Prevention, weight gain, Amenorrhea

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.

Interventions

DRUGMetformin

0.5g bid 26 weeks

OTHERStarch tablets

0.5g bid 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in weight at 24 weeks	baseline, 8 week, 16 week, 24 week	The data will be presented

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026