Metabolic Profile and Anthropometric Changes in Schizophrenia (MetS)

Central Institute of Psychiatry, Ranchi, India

Status: Completed

Conditions: Diabetes; Obesity; Metabolic Syndrome

Treatments: Drug: Risperidone; Drug: Olanzapine; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT00534183

CIPMETS001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,006 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,006 participants in 3 patient groups

1

Experimental group

Description:

Olanzapine

Treatment:

Drug: Olanzapine

2

Active Comparator group

Description:

Risperidone

Treatment:

Drug: Risperidone

3

Active Comparator group

Description:

haloperidol

Treatment:

Drug: Haloperidol