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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Ambulatório de Bipolaridade
ClinicalTrials.gov Identifier:
NCT00740259
First received: August 20, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740259

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

No publications provided by Ambulatório de Bipolaridade

Additional 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)
Study First Received: August 20, 2008
Last Updated: August 20, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Ambulatório de Bipolaridade:
flunarizine
schizophrenia
antipsychotic

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

ClinicalTrials.gov processed this record on October 20, 2014