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Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities

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ClinicalTrials.gov Identifier: NCT02751307
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
Taipei City Hospital
Information provided by (Responsible Party):
Chun-Hsin Chen, Taipei Medical University WanFang Hospital

Brief Summary:

Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in clozapine-treated patients with pre-existing metabolic abnormalities.

Methods:

In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or 1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at week-4, week-8, and week-12.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: metformin 500 mg Drug: clozapine 100 mg Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Metabolic Abnormalities in Patients With Schizophrenia: Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: metformin 500 mg/d; clozapine 100 mg
In the first week, 500 mg of metformin was administered in the morning. In the second week, the dosage was revised to 500 mg of metformin in the morning and the placebo in the evening. During metformin intervention period, the clozapine dose remained unchanged in these recruited clozapine-treated patients.
Drug: metformin 500 mg
metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d
Other Name: Loditon

Drug: clozapine 100 mg
Clozapine dose remained unchanged during metformin intervention period in recruited patients.
Other Name: Clozaril

Active Comparator: metformin 1000 mg/d; clozapine 100 mg
In the first week, 500 mg of metformin was administered in the morning. In the second week, 500 mg of metformin twice a day was administered. During metformin intervention period, the clozapine dose remained unchanged in these recruited clozapine-treated patients.
Drug: metformin 500 mg
metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d
Other Name: Loditon

Drug: clozapine 100 mg
Clozapine dose remained unchanged during metformin intervention period in recruited patients.
Other Name: Clozaril

Placebo Comparator: placebo; clozapine 100 mg
In the first week, one pill of placebo was given and in the second week, placebo BID was given. During metformin intervention period, the clozapine dose remained unchanged in these recruited clozapine-treated patients.
Drug: metformin 500 mg
metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d
Other Name: Loditon

Drug: clozapine 100 mg
Clozapine dose remained unchanged during metformin intervention period in recruited patients.
Other Name: Clozaril




Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: baseline; week-4; week-8; week-12 ]

Secondary Outcome Measures :
  1. Changes in waist circumference [ Time Frame: baseline; week-4; week-8; week-12 ]
  2. Changes in blood pressure [ Time Frame: baseline; week-4; week-8; week-12 ]
  3. Changes in fasting triglyceride level [ Time Frame: baseline; week-4; week-8; week-12 ]
  4. Changes in fasting high-density lipoprotein cholesterol level [ Time Frame: baseline; week-4; week-8; week-12 ]
  5. Changes in fasting glucose level [ Time Frame: baseline; week-4; week-8; week-12 ]
  6. Changes in scores of positive and negative syndrome scale (PANSS) [ Time Frame: baseline; week-4; week-8; week-12 ]
    Recruited patients were interviewed by research assistants to get PANSS scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
  2. aged 20-65 years
  3. had taken clozapine for at least 3 months
  4. had at least one of the following metabolic abnormalities: BMI ≥ 24; WC > 90 cm (men) or 80 cm (women); fasting serum TG level ≥ 150 mg/dL; fasting serum HDL-C level ≤ 40 mg/dL (men) or 50 mg/dL (women); systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg; current use of antihypertensive agents; and FPG level = 100-126 mg/dL.

Exclusion Criteria:

  1. history of diabetes mellitus
  2. current use of hypoglycemic or hypolipidemic agents
  3. pregnancy
  4. allergy to metformin
  5. a creatinine level > 1.4 ng/dL
  6. an abnormal liver function test result
  7. chronic cardiopulmonary insufficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751307


Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Taipei City Hospital
Investigators
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Principal Investigator: Chun-Hsin Chen, MD Department of Psychiatry, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chun-Hsin Chen, Attending Psychiatrist, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02751307     History of Changes
Other Study ID Numbers: TMU-JIRB 201303005
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chun-Hsin Chen, Taipei Medical University WanFang Hospital:
metformin
clozapine
schizophrenia
metabolic traits

Additional relevant MeSH terms:
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Congenital Abnormalities
Metabolic Syndrome
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Clozapine
Hypoglycemic Agents
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents