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

September 21, 2007
September 21, 2007
June 2006
Not Provided
Study of metabolic profile [ Time Frame: 6 weeks ]
Same as current
No Changes Posted
Study of obesity and diabetes [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
Metabolic Profile and Anthropometric Changes in Schizophrenia
Metabolic Profile and Anthropometric Changes in Schizophrenia

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
  • Metabolic Syndrome
  • Diabetes
  • Obesity
  • Drug: Olanzapine
    Olanzapine in dose range of 10-20mg
  • Drug: Risperidone
    Risperidone 1-6mg
  • Drug: Haloperidol
    Haloperidol 10-20mg
  • Experimental: 1
    Olanzapine
    Intervention: Drug: Olanzapine
  • Active Comparator: 2
    Risperidone
    Intervention: Drug: Risperidone
  • Active Comparator: 3
    haloperidol
    Intervention: Drug: Haloperidol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2006
December 2006
Not Provided

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00534183
CIPMETS001
Yes
Not Provided
Central Institute of Psychiatry, Ranchi, India
Not Provided
Principal Investigator: Sahoo Saddichha, DPM Central Institute of Psychiatry
Central Institute of Psychiatry, Ranchi, India
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP