Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)
Primary Purpose
Metabolic Syndrome, Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Olanzapine
Risperidone
Haloperidol
Sponsored by
About this trial
This is an interventional screening trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Obesity, Diabetes
Eligibility 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
Sites / Locations
- Central Institute of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Olanzapine
Risperidone
haloperidol
Outcomes
Primary Outcome Measures
Study of metabolic profile
Secondary Outcome Measures
Study of obesity and diabetes
Full Information
NCT ID
NCT00534183
First Posted
September 21, 2007
Last Updated
September 21, 2007
Sponsor
Central Institute of Psychiatry, Ranchi, India
1. Study Identification
Unique Protocol Identification Number
NCT00534183
Brief Title
Metabolic Profile and Anthropometric Changes in Schizophrenia
Acronym
MetS
Official Title
Metabolic Profile and Anthropometric Changes in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Institute of Psychiatry, Ranchi, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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. "
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes, Obesity
Keywords
Metabolic syndrome, Obesity, Diabetes
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2006 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Olanzapine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Risperidone
Arm Title
3
Arm Type
Active Comparator
Arm Description
haloperidol
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Olanzapine in dose range of 10-20mg
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Risperidone 1-6mg
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Haloperidol 10-20mg
Primary Outcome Measure Information:
Title
Study of metabolic profile
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Study of obesity and diabetes
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahoo Saddichha, DPM
Organizational Affiliation
Central Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Psychiatry
City
Ranchi
ZIP/Postal Code
834009
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
18052574
Citation
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. doi: 10.4088/jcp.v68n1120.
Results Reference
derived
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Metabolic Profile and Anthropometric Changes in Schizophrenia
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