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WithdrawnNCT01423487Updated Aug 2, 2012

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

An interventional study of Metformin and Starch tablets in Weight Gain and Amenorrhea, sponsored by Central South University. Withdrawn at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by Central South University · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Difficult to obtain informed consent
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Weight Gain
  • Amenorrhea

Keywords

  • Metformin
  • Risperidone
  • Prevention
  • weight gain
  • Amenorrhea
03

In context

Weight Gain

408 studies on the registry are indexed under Weight Gain; 51 are open to participants now.

Browse Weight Gain studies →

Lead sponsor

Central South University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.

Browse Central South University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    efficacy and safety

    To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.

    Drug: Metformin

  • Placebo comparator
    placebo comparator

    To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea.

    Other: Starch tablets

Interventions

  • DrugMetformin

    0.5g bid 26 weeks

  • OtherStarch tablets

    0.5g bid 26 weeks

06

What researchers measure

Primary outcomes

  1. Change from Baseline in weight at 24 weeks

    The data will be presented

    Time frame: baseline, 8 week, 16 week, 24 week

Secondary outcomes

  1. Change from Baseline in menstruation at 24 weeks

    The data will be presented

    Time frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week

07

Study locations

1 site
  • Mental Health Institute of The Second Xiangya Hospital
    Changsha, Hunan 410011, China
08

References and documents

Publications

  • Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. doi: 10.1001/jama.2007.56-b. PubMed 18182600 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01423487
Lead sponsor
Central South University
Responsible party
Jing-Ping Zhao (Professor,Deputy Director of Mental Health Institute of The Second Xiangya Hospital, Central South University) — Principal investigator
First posted
Aug 26, 2011
Start date
Aug 2011
Primary completion
Feb 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Aug 2, 2012

Study contacts

Jing-Ping Zhao, Dr., Ph.D.
study chair · Mental Health Institute of The Second Xiangya Hospital, Central South University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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