We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534183
First Posted: September 24, 2007
Last Update Posted: September 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Central Institute of Psychiatry, Ranchi, India
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00534183     History of Changes
Other Study ID Numbers: CIPMETS001
First Submitted: September 21, 2007
First Posted: September 24, 2007
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by Central Institute of Psychiatry, Ranchi, India:
Metabolic syndrome
Obesity
Diabetes

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Risperidone
Olanzapine
Haloperidol
Haloperidol decanoate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators