SchizophreniaNCT01177709

Metformin for Weight Loss in Schizophrenia

A study testing Metformin in people with Schizophrenia and Obesity, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia, Obesity
What is being tested?: Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: May 2008to Apr 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients will be 18-70 years of age;
Currently hospitalized or an outpatient at MPC;
BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Who cannot join

Age below 18 or over 70;
Patient is currently already treated with metformin.

Trial locations and contacts

1 site in 1 country.

United States1 site

Manhatan Psychiatric Center
New York, New York, 10035

Other trials in United States

About this study

Official title: Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Read the detailed description

Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Conditions: Schizophrenia, Obesity
Being tested: Metformin
Keywords: schizophrenia, antipsychotics, obesity, diabetes
Medical subject headings: Schizophrenia, Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.

Study groups in NCT01177709
Study group	Role	What they receive
Metformin	Experimental	Not described Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight (wt) in Pounds (Lbs)..
Patients weight in pounds
Measured: baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (2)

Glucose Levels
Fasting glucose
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Insulin Level
fasting serum insulin uIU/ml.
Measured: baseline, 4 weks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Apr 2011

First posted9 Aug 2010 (estimated)
Study startMay 2008
Primary completionApr 2011
Study completionApr 2011

Why it stopped: PI moved to different institution. Decided to concentrate on different studies.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177709
Sponsor's protocol ID: 091/C22
Status last verified: Aug 2017
First submitted: 23 Apr 2010
Last updated: 1 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication
ClinicalTrials.gov ID: NCT01177709
Acronym / sponsor ID: 091/C22
Conditions: Schizophrenia, Obesity
Keywords: schizophrenia, antipsychotics, obesity, diabetes
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI moved to different institution. Decided to concentrate on different studies.
Enrolment: 12 participants (actual)
Lead sponsor: Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
Study start: May 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 7 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Metformin	Experimental	Drug: Metformin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients will be 18-70 years of age;
Currently hospitalized or an outpatient at MPC;
BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Key exclusion criteria (2 listed)

Age below 18 or over 70;
Patient is currently already treated with metformin.

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
Metforminmetformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.	Drug	Metformin

Primary outcome

Weight (wt) in Pounds (Lbs)..
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Patients weight in pounds

2 secondary outcomes

Glucose Levels
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Insulin Level
Time frame: baseline, 4 weks, 8 weeks, 12 weeks

Results and safety

Results posted to the registry on 7 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin	12	12

Primary outcome: Weight (wt) in Pounds (Lbs)..

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks. Mean (Standard Error). Unit: weight(wt) in pounds(lbs)

Measure	Metformin n = 12
baseline wt lbs	250.97 (11.52)
4 week wt lbs	244.73 (10.84)
8 week wt lbs	244.15 (10.06)
12 week wt lbs	240.44 (9.22)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin	2 of 12 (16.7%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): This is an open non-blinded study in a small number of subjects. However, it is unlikely that outcomes measures of weight, glucose, and insulin, would have been likely to be affected by non-blinding of subjects and investigators. .

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Robert C. Smith, MD PHD principal investigator

Nathan Kline Institute for Psychiatric Research

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 in people with Schizophrenia and Obesity, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.

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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 1 Sep 2017. 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 United States. 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. 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?

Yes. Results are posted in the registry (first posted 7 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weight (wt) in Pounds (Lbs).. (time frame: baseline, 4 weeks, 8 weeks, 12 weeks). 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 NCT01177709.

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 1 Sep 2017.