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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740259
• Other study ID #: Flunarizine for schizophrenia
• Secondary ID: 02T-264 (SMRI)
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2008
• Last updated: August 20, 2008
• Start date: September 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2008
• Source: Ambulatório de Bipolaridade
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Ambulatório de Bipolaridade	Stanley Medical Research Institute

Country where clinical trial is conducted

Brazil,