NCT00534183

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. "

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

September 21, 2007

Last Update Submit

September 21, 2007

Conditions

Metabolic SyndromeDiabetesObesity

Keywords

Metabolic syndromeObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • Study of metabolic profile

    6 weeks

Secondary Outcomes (1)

  • Study of obesity and diabetes

    6 weeks

Study Arms (3)

1

EXPERIMENTAL

Olanzapine

Drug: Olanzapine

2

ACTIVE COMPARATOR

Risperidone

Drug: Risperidone

3

ACTIVE COMPARATOR

haloperidol

Drug: Haloperidol

Interventions

OlanzapineDRUG

Olanzapine in dose range of 10-20mg

1
RisperidoneDRUG

Risperidone 1-6mg

2
HaloperidolDRUG

Haloperidol 10-20mg

3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-40 years
  • Diagnosis of schizophrenia
  • Drug naive on admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Psychiatry

Ranchi, 834009, India

Location

Related Publications (2)

  • Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

    PMID: 38958149DERIVED

  • 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.

    PMID: 18052574DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusObesity

Interventions

OlanzapineRisperidoneHaloperidol

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Sahoo Saddichha, DPM

    Central Institute of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

June 1, 2006

Study Completion

December 1, 2006

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

IN(1)