The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metformin for Weight Loss in Schizophrenia

NCT01177709

Schizophrenia Obesity

TERMINATED NA

Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients

NCT01300637

Obesity Metabolic Syndrome Schizophrenia

UNKNOWN NA

Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial

NCT07342764

Antipsychotic-induced Weight Gain (AIWG) Antipsychotic-induced Weight Gain Schizophrenia Spectrum and Other Psychotic Disorders

NOT_YET_RECRUITING PHASE4

Effects of Metformin and Fish Oil on Treatment With Clozapine

NCT02140788

Schizophrenia Schizo-affective Disorder

TERMINATED PHASE4

Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

NCT00617240

Weight Gain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin group

Metformin 500mg 1 tablet p.o. bid

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

metformin 500mg p.o. bid for 24 weeks

Placebo group

1 tablet p.o. bid

Group Type PLACEBO_COMPARATOR

Placebo (for metformin)

Intervention Type DRUG

placebo 1T bid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

metformin 500mg p.o. bid for 24 weeks

Intervention Type DRUG

Placebo (for metformin)

placebo 1T bid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diabex placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* Patient taking clozapine 3months or more
* Patient increased in weight more than 10 % of that of before antipsychotics use

Exclusion Criteria

* Patient taking other antipsychotics with clozapine
* Patient in treatment of diabetes
* Patient in treatment of dyslipidemia
* Allergy or hypersensitivity to metformin
* Pregnant or breast-feeding female patient.
* Patient with severe medical condition

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No