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Metabolic Profile and Anthropometric Changes in Schizophrenia

NCT ID: NCT00534183

Last Updated: 2007-09-24

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-12-31

Brief Summary

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"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "

Detailed Description

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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.

Conditions

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Metabolic Syndrome Diabetes Obesity

Keywords

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Metabolic syndrome Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Olanzapine

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

Olanzapine in dose range of 10-20mg

2

Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Risperidone 1-6mg

3

haloperidol

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Haloperidol 10-20mg

Interventions

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Risperidone

Risperidone 1-6mg

Intervention Type DRUG

Haloperidol

Haloperidol 10-20mg

Intervention Type DRUG

Olanzapine

Olanzapine in dose range of 10-20mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Institute of Psychiatry, Ranchi, India

OTHER

Sponsor Role lead

Principal Investigators

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Sahoo Saddichha, DPM

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Psychiatry

Locations

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Central Institute of Psychiatry

Ranchi, , India

Site Status

Countries

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India

References

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Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

Reference Type DERIVED
PMID: 38958149 (View on PubMed)

Saddichha S, Manjunatha N, Ameen S, Akhtar S. Effect of olanzapine, risperidone, and haloperidol treatment on weight and body mass index in first-episode schizophrenia patients in India: a randomized, double-blind, controlled, prospective study. J Clin Psychiatry. 2007 Nov;68(11):1793-8. doi: 10.4088/jcp.v68n1120.

Reference Type DERIVED
PMID: 18052574 (View on PubMed)

Other Identifiers

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CIPMETS001

Identifier Type: -

Identifier Source: org_study_id