Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol

August 20, 2008 updated by: Ambulatório de Bipolaridade

Is Flunarizine a Cheap, Well-Tolerated and Long-Acting Atypical Antipsychotic? A Randomized Double-Blind Flexible-Dose Clinical Trial Versus Haloperidol for the Treatment of Schizophrenia

Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and migraine. It also has the mechanism of action associated with antipsychotic activity (D2 receptor blockade), but has never been tested as such. The investigators hypothesis is that flunarizine can be an atypical antipsychotic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main advantage of flunarizine over other D2 receptor blockers is its long half-life, so that it may be administered weekly or may delay relapse if medication is interrupted.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-900
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45.

Exclusion Criteria:

  • Clinical disease
  • Pregnancy
  • Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ambulatório de Bipolaridade

Collaborators

Stanley Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

August 22, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flunarizine for schizophrenia
  • 02T-264 (SMRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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