Text Size

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:

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
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):

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:
Diabetes Mellitus
Obesity
Schizophrenia
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
 Hyperinsulinism
Haloperidol
Olanzapine
Haloperidol decanoate
Risperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 21, 2013