Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

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

September 21, 2007
September 24, 2007
September 24, 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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
    Intervention: Drug: Olanzapine
  • Active Comparator: 2
    Intervention: Drug: Risperidone
  • Active Comparator: 3
    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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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