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Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

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ClinicalTrials.gov Identifier: NCT00534183
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
Sponsor:
Information provided by:
Central Institute of Psychiatry, Ranchi, India

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Diabetes Obesity Drug: Olanzapine Drug: Risperidone Drug: Haloperidol Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: Metabolic Profile and Anthropometric Changes in Schizophrenia
Study Start Date : June 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Study of metabolic profile [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Study of obesity and diabetes [ Time Frame: 6 weeks ]

Eligibility Criteria
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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
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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
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India
Central Institute of Psychiatry
Ranchi, India, 834009
Sponsors and Collaborators
Central Institute of Psychiatry, Ranchi, India
Investigators
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Principal Investigator: Sahoo Saddichha, DPM Central Institute of Psychiatry
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00534183    
Other Study ID Numbers: CIPMETS001
First Posted: September 24, 2007    Key Record Dates
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:
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Metabolic Syndrome
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Haloperidol
Olanzapine
Risperidone
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