NCT00036361

Brief Summary

The purpose of this study is to learn if aripiprazole is effective in the treatment of a large number of persons diagnosed with schizophrenia or schizoaffective disorders

Trial Health

87
On Track

Trial Health Score

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

Enrollment
444

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_3 schizophrenia

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

First Submitted

Initial submission to the registry

May 8, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

November 11, 2013

Status Verified

September 1, 2007

Enrollment Period

6 months

First QC Date

May 8, 2002

Last Update Submit

November 7, 2013

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Safety Assessments

Secondary Outcomes (1)

  • Safety Assessments

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with Schizophrenia or Schizoaffective Disorder

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Wallingford, Connecticut, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

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 Design

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

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 10, 2002

Study Start

July 1, 2002

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

November 11, 2013

Record last verified: 2007-09

Locations

US(1)