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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 22, 2008
Last Update Posted: August 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Stanley Medical Research Institute
Information provided by:
Ambulatório de Bipolaridade
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.

Condition Intervention Phase
Schizophrenia Drug: Flunarizine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Ambulatório de Bipolaridade:

Enrollment: 70
Study Start Date: September 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740259

Universidade Federal de São Paulo
São Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Ambulatório de Bipolaridade
Stanley Medical Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diogo Rizzato Lara, Ambulatório de Bipolaridade
ClinicalTrials.gov Identifier: NCT00740259     History of Changes
Other Study ID Numbers: Flunarizine for schizophrenia
02T-264 (SMRI)
First Submitted: August 20, 2008
First Posted: August 22, 2008
Last Update Posted: August 22, 2008
Last Verified: August 2008

Keywords provided by Ambulatório de Bipolaridade:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Haloperidol decanoate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Vasodilator Agents