Weight GainNCT01423487
Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea
A study testing Metformin and Starch tablets in people with Weight Gain and Amenorrhea, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Weight Gain, Amenorrhea
- What is being tested?
- Metformin and Starch tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute of The Second Xiangya Hospital
Changsha, Hunan, 410011
About this study
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
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.
- Conditions
- Weight Gain, Amenorrhea
- Being tested
- Metformin, Starch tablets
- Keywords
- Metformin, Risperidone, Prevention, weight gain, Amenorrhea
- Medical subject headings
- Weight Gain, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
0.5g bid 26 weeks
Starch tabletsOther
0.5g bid 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| efficacy and safety | Experimental | To investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea. Receives: Drug: Metformin |
| placebo comparator | Placebo comparator | To investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea. Receives: Other: Starch tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in weight at 24 weeks
The data will be presented
Measured: baseline, 8 week, 16 week, 24 week
Secondary outcomes (1)
Change from Baseline in menstruation at 24 weeks
The data will be presented
Measured: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Difficult to obtain informed consent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Ping Zhao, Central South University
- Investigators
- Jing-Ping Zhao, Dr., Ph.D., Study chair, Mental Health Institute of The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423487
- Sponsor's protocol ID
- CSUXXEYYJYS-051
- Status last verified
- Jul 2012
- First submitted
- 18 Aug 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01423487
- Acronym / sponsor ID
- CSUXXEYYJYS-051
- Conditions
- Weight Gain, Amenorrhea
- Keywords
- Metformin, Risperidone, Prevention, weight gain, Amenorrhea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to obtain informed consent
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| efficacy and safety | Experimental | Drug: MetforminTo investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea. |
| placebo comparator | Placebo comparator | Other: Starch tabletsTo investigate whether plcebo also could preventing patients with Risperidone from weight gain and amenorrhea. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin0.5g bid 26 weeks | Drug | efficacy and safety |
| Starch tablets0.5g bid 26 weeks | Other | placebo comparator |
Primary outcome
Change from Baseline in weight at 24 weeks
Time frame: baseline, 8 week, 16 week, 24 week
The data will be presented
1 secondary outcome
Change from Baseline in menstruation at 24 weeks
Time frame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Background: PubMed 18182600Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Ping Zhao, Dr., Ph.D. study chair
Mental Health Institute of The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Starch tablets in people with Weight Gain and Amenorrhea, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in weight at 24 weeks (time frame: baseline, 8 week, 16 week, 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.