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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Flunarizine
Sponsored by
Ambulatório de Bipolaridade
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring flunarizine, schizophrenia, antipsychotic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de São Paulo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 20, 2008
Last Updated
August 20, 2008
Sponsor
Ambulatório de Bipolaridade
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00740259
Brief Title
Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ambulatório de Bipolaridade
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
flunarizine, schizophrenia, antipsychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flunarizine
Intervention Description
For 1 week, 40 mg/day. From week 2 to 3, 20 mg/day. Form week 4 onwards, dosage increment or reduction of 10mg/day was allowed according to efficacy and tolerability.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19192440
Citation
Bisol LW, Brunstein MG, Ottoni GL, Ramos FL, Borba DL, Daltio CS, de Oliveira RV, Paz GE, de Souza SE, Bressan RA, Lara DR. Is flunarizine a long-acting oral atypical antipsychotic? A randomized clinical trial versus haloperidol for the treatment of schizophrenia. J Clin Psychiatry. 2008 Oct;69(10):1572-9. doi: 10.4088/jcp.v69n1007. Epub 2008 Sep 1.
Results Reference
derived

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

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