Metabolic Profile and Anthropometric Changes in Schizophrenia - Full Text View

Sponsored by:	Central Institute of Psychiatry, Ranchi, India
Information provided by:	Central Institute of Psychiatry, Ranchi, India
ClinicalTrials.gov Identifier:	NCT00534183

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

MedlinePlus related topics: Diabetes Obesity Schizophrenia

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Safety Study
Official Title:	Metabolic Profile and Anthropometric Changes in Schizophrenia

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
1: Experimental Olanzapine	Drug: Olanzapine Olanzapine in dose range of 10-20mg
2: Active Comparator Risperidone	Drug: Risperidone Risperidone 1-6mg
3: Active Comparator 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

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 National Clinical Trials Identifier (NCT ID):

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.

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

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

Metabolic syndrome
Obesity
Diabetes

Study placed in the following topic categories:

Neurotransmitter Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Overweight
Body Weight
Schizophrenia
Haloperidol
Signs and Symptoms
Dopamine
Mental Disorders
Nutrition Disorders
Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features
Obesity
Tranquilizing Agents
Risperidone
Diabetes Mellitus
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Haloperidol decanoate
Overnutrition
Dopamine Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Olanzapine
Antiemetics
Overweight
Haloperidol
Body Weight
Schizophrenia
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes

Mental Disorders
Syndrome
Therapeutic Uses
Nutrition Disorders
Schizophrenia and Disorders with Psychotic Features
Obesity
Tranquilizing Agents
Disease
Risperidone
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009