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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:


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):
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
Obesity
Schizophrenia
Syndrome
Body Weight
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Olanzapine
Risperidone
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents

ClinicalTrials.gov processed this record on November 20, 2014