SchizophreniaPhase 4NCT00740259
Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol
A Phase 4 study testing Flunarizine in people with Schizophrenia, run by Ambulatório de Bipolaridade at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Flunarizine
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2004to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45.
Who cannot join
- Clinical disease
- Pregnancy
- Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Flunarizine
- Keywords
- flunarizine, schizophrenia, antipsychotic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlunarizineDrug
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startSep 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambulatório de Bipolaridade
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740259
- Sponsor's protocol ID
- Flunarizine for schizophrenia
- Other IDs
- 02T-264 (SMRI)
- Status last verified
- Aug 2008
- First submitted
- 20 Aug 2008
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bisol LW, Brunstein MG, Ottoni GL, Ramos FL, Borba DL, Daltio CS, de Oliveira RV, Paz GE, de Souza SE, Bressan RA, Lara DR. Is flunarizine a long-acting oral atypical antipsychotic? A randomized clinical trial versus haloperidol for the treatment of schizophrenia. J Clin Psychiatry. 2008 Oct;69(10):1572-9. doi: 10.4088/jcp.v69n1007. Epub 2008 Sep 1.
PubMed 19192440
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740259
- Acronym / sponsor ID
- Flunarizine for schizophrenia
- Conditions
- Schizophrenia
- Keywords
- flunarizine, schizophrenia, antipsychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ambulatório de BipolaridadeUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45.
Key exclusion criteria (3 listed)
- Clinical disease
- Pregnancy
- Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlunarizineFor 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2008.
- Derived from this study: PubMed 19192440Bisol LW, Brunstein MG, Ottoni GL, Ramos FL, Borba DL, Daltio CS, de Oliveira RV, Paz GE, de Souza SE, Bressan RA, Lara DR. Is flunarizine a long-acting oral atypical antipsychotic? A randomized clinical trial versus haloperidol for the treatment of schizophrenia. J Clin Psychiatry. 2008 Oct;69(10):1572-9. doi: 10.4088/jcp.v69n1007. Epub 2008 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flunarizine in people with Schizophrenia, run by Ambulatório de Bipolaridade at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.