Metabolic Profile and Anthropometric Changes in Schizophrenia

Obesity Clinical Trial

— MetS  

Official title:

Metabolic Profile and Anthropometric Changes in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534183
• Other study ID #: CIPMETS001
• Status: Completed
• Phase: N/A
• First received: September 21, 2007
• Last updated: September 21, 2007
• Start date: June 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2007
• Source: Central Institute of Psychiatry, Ranchi, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2006
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Drug:
• Olanzapine
Olanzapine in dose range of 10-20mg
• Risperidone
Risperidone 1-6mg
• Haloperidol
Haloperidol 10-20mg

Locations

Country	Name	City	State
India	Central Institute of Psychiatry	Ranchi

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Psychiatry, Ranchi, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of metabolic profile		6 weeks
Secondary	Study of obesity and diabetes		6 weeks