NCT00237939

Brief Summary

The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3 schizophrenia

Geographic Reach
5 countries

20 active sites

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, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 8, 2013

Status Verified

October 1, 2007

Enrollment Period

4.2 years

First QC Date

October 11, 2005

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression-Improvement at endpoint

Secondary Outcomes (1)

  • Patients' and caregivers' medication preference

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical DSM-IV diagnosis of schizophrenia
  • Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

You may not qualify if:

  • Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
  • Prisoners or subjects compulsory detained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Local Institution

Antwerp, Belgium

Location

Local Institution

Brussels, Belgium

Location

Local Institution

Diest, Belgium

Location

Local Institution

Kortenberg, Belgium

Location

Local Institution

Liège, Belgium

Location

Local Institution

Sint-Michiels, Belgium

Location

Local Institution

Sint-Niklaas, Belgium

Location

Local Institution

Sint-Truiden, Belgium

Location

Local Institution

Tournai, Belgium

Location

Local Institution

Rennes, France

Location

Local Institution

Amersfoort, Netherlands

Location

Local Institution

Raalte, Netherlands

Location

Local Institution

Rotterdam, Netherlands

Location

Local Institution

Barcelos, Portugal

Location

Local Institution

Ceira, Portugal

Location

Local Institution

Coimbra, Portugal

Location

Local Institution

Lisbon, Portugal

Location

Local Institution

Barcelona, Spain

Location

Local Institution

Salamanca, Spain

Location

Local Institution

Seville, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hervé Allain, MD

    Faculté de Médecine de Rennes I, laboratoire de pharmacologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

September 1, 2002

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 8, 2013

Record last verified: 2007-10

Locations

NL(3)PT(4)ES(3)FR(1)BE(9)