NCT00740259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
Last Updated

August 22, 2008

Status Verified

August 1, 2008

Enrollment Period

2.7 years

First QC Date

August 20, 2008

Last Update Submit

August 20, 2008

Conditions

Schizophrenia

Keywords

flunarizineschizophreniaantipsychotic

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45.

You may not qualify if:

  • Clinical disease
  • Pregnancy
  • Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 19192440DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Flunarizine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

September 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 22, 2008

Record last verified: 2008-08

Locations

BR(1)