NCT00101569

Brief Summary

The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

7 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

March 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

November 8, 2013

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

January 12, 2005

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • acceptability

Study Arms (2)

A1

EXPERIMENTAL
Drug: Aripiprazole

A2

EXPERIMENTAL
Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).

Also known as: Abilify
A1

Eligibility Criteria

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

You may qualify if:

  • Stable patients currently receiving aripiprazole or other antipsychotic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Local Institution

Anaheim, California, United States

Location

Local Institution

National City, California, United States

Location

Local Institution

North Miami Beach, Florida, United States

Location

Local Institution

Overland Park, Kansas, United States

Location

Local Institution

Staten Island, New York, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Falls Church, Virginia, United States

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

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2005

First Posted

January 13, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 8, 2013

Record last verified: 2008-07

Locations

US(7)