Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

This study has been completed.

Sponsor:

Information provided by:

Central Institute of Psychiatry, Ranchi, India

ClinicalTrials.gov Identifier:

NCT00534183

First received: September 21, 2007

Last updated: NA

Last verified: September 2007

History: No changes posted

Purpose

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

Condition	Intervention
Metabolic Syndrome Diabetes Obesity	Drug: Olanzapine Drug: Risperidone Drug: Haloperidol


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening
Official Title:	Metabolic Profile and Anthropometric Changes in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Risperidone Olanzapine Olanzapine pamoate

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Central Institute of Psychiatry, Ranchi, India:

Primary Outcome Measures:

Study of metabolic profile [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Study of obesity and diabetes [ Time Frame: 6 weeks ]


Enrollment:	2006
Study Start Date:	June 2006
Study Completion Date:	December 2006

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534183

Locations


India
Central Institute of Psychiatry
Ranchi, India, 834009

Sponsors and Collaborators

Central Institute of Psychiatry, Ranchi, India

Investigators


Principal Investigator:	Sahoo Saddichha, DPM	Central Institute of Psychiatry

More Information

No publications provided by Central Institute of Psychiatry, Ranchi, India

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00534183 History of Changes
Other Study ID Numbers:	CIPMETS001
Study First Received:	September 21, 2007
Last Updated:	September 21, 2007
Health Authority:	India: Institutional Review Board

Keywords provided by Central Institute of Psychiatry, Ranchi, India:


Metabolic syndrome Obesity Diabetes

Additional relevant MeSH terms:


Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Haloperidol Risperidone Anti-Dyskinesia Agents Antiemetics Antipsychotic Agents Autonomic Agents Central Nervous System Agents Central Nervous System Depressants	Dopamine Agents Dopamine Antagonists Gastrointestinal Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 01, 2015

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