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Clinical Trials/CTRI/2011/091/000140
CTRI/2011/091/000140
Completed
Phase 3

A randomized, open label, comparative, multicentric, phase 3 clinical study to assess the efficacy and safety of Blonanserin tablets in comparison with Haloperidol tablets in patients suffering from schizophrenia

Cadila Healthcare Ltd4 sites in 1 country200 target enrollmentStarted: January 27, 2011Last updated:
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Overview

Phase
Phase 3
Status
Completed
Enrollment
200
Locations
4
Primary Endpoint
The degree of improvement in the PANSS total score
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is a randomized, open label, active controlled, multicentric study comparing the safety and efficacy of Blonanserin twice daily and Haloperidol thrice daily in 200 patients with schizophrenia that will be conducted in India. The primary outcome measures will be the change in the PANSS score.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Patients between 18-65 years of age.
  • •2.Patients with diagnosis of schizophrenia.
  • •3.Informed consent.

Exclusion Criteria

  • •1.Pregnancy and/or lactation.
  • •2.Patients with suicidal tendencies.
  • •3.Patients with relevant CNS disorders or history of such disorders.
  • •4.Patients with a history of neuroleptic malignant syndrome (NMS).
  • •5.Patients with uncontrolled diabetes or significant cardiovascular diseases.
  • •6.Patients with angle-closure glaucoma, benign prostatic hyperplasia, urinary retention or paralytic ileus.
  • •7.Patients with significant renal or hepatic impairment, acute infections, leucopenia, hyperthyroidism or SIADH.
  • •8.Impoverished patients.
  • •9.Patients with an organic psychiatric disorder.
  • •10.History of hypersensitivity to study medication.

Outcomes

Primary Outcomes

The degree of improvement in the PANSS total score

Time Frame: Baseline, monthly & at the end of study

Secondary Outcomes

  • (1)The degree of improvement in the PANSS factor scores((2)The degree of improvement in the Clinical Global Impressions (CGI) ? severity and improvement scores)

Investigators

Sponsor Class
Pharmaceutical industry-Indian

Study Sites (4)

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