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

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ClinicalTrials.gov Identifier: NCT00740259
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Ambulatório de Bipolaridade

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Flunarizine Phase 4

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  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Haloperidol
U.S. FDA Resources


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.



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

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


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

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 Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 22, 2008
Last Verified: August 2008

Keywords provided by Ambulatório de Bipolaridade:
flunarizine
schizophrenia
antipsychotic

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