NCT01423487

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

August 18, 2011

Last Update Submit

July 31, 2012

Conditions

Weight GainAmenorrhea

Keywords

MetforminRisperidonePreventionweight gainAmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in weight at 24 weeks

    The data will be presented

    baseline, 8 week, 16 week, 24 week

Secondary Outcomes (1)

  • Change from Baseline in menstruation at 24 weeks

    baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week

Study Arms (2)

efficacy and safety

EXPERIMENTAL

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

MetforminDRUG

0.5g bid 26 weeks

efficacy and safety
Starch tabletsOTHER

0.5g bid 26 weeks

placebo comparator

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute of The Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

Related Publications (1)

  • 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.

    PMID: 18182600BACKGROUND

MeSH Terms

Conditions

Weight GainAmenorrhea

Interventions

MetforminStarch

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic Processes

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Jing-Ping Zhao, Dr., Ph.D.

    Mental Health Institute of The Second Xiangya Hospital, Central South University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Deputy Director of Mental Health Institute of The Second Xiangya Hospital

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 26, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

CN(1)