Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol
This study has been completed.
Sponsor:
Ambulatório de Bipolaridade
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Detailed Description:
-
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.
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 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 Schizophrenia and Disorders with Psychotic Features Mental Disorders Flunarizine Haloperidol Haloperidol decanoate Antipsychotic Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Histamine H1 Antagonists Histamine Antagonists |
Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs Vasodilator Agents Anticonvulsants Central Nervous System Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013