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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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flunarizine schizophrenia antipsychotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Flunarizine

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ambulatório de Bipolaridade

Locations

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Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED

PMID: 19192440 (View on PubMed)

Other Identifiers

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02T-264 (SMRI)

Identifier Type: -

Identifier Source: secondary_id

Flunarizine for schizophrenia