Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

September 21, 2007 updated by: Central Institute of Psychiatry, Ranchi, India
"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.

Study Type

Interventional

Enrollment (Actual)

2006

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ranchi, India, 834009
        • Central Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18-40 years
  • Diagnosis of schizophrenia
  • Drug naive on admission

Exclusion Criteria:

  • Other psychiatric co-morbidity
  • History of severe physical illness
  • Alcohol and substance abuse or dependence
  • History of pre-existing diabetes or hypertension
  • Family history of hypertension or diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Olanzapine
Drug: Olanzapine
Olanzapine in dose range of 10-20mg
Active Comparator: 2
Risperidone
Drug: Risperidone
Risperidone 1-6mg
Active Comparator: 3
haloperidol
Drug: Haloperidol
Haloperidol 10-20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study of metabolic profile
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Study of obesity and diabetes
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Psychiatry, Ranchi, India

Investigators

  • Principal Investigator: Sahoo Saddichha, DPM, Central Institute of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 21, 2007

First Submitted That Met QC Criteria

September 21, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 24, 2007

Last Update Submitted That Met QC Criteria

September 21, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIPMETS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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