NCT00036127

Brief Summary

Study to learn if the alternate formulation is effective in agitated schizophrenic patients

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

16 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

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2002

Completed
8 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

9 months

First QC Date

May 7, 2002

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Keywords

agitated schizophrenic patients

Interventions

aripiprazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Agitated schizophrenic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Local Institution

Anaheim, California, United States

Location

Local Institution

Cerritos, California, United States

Location

Local Institution

Chula Vista, California, United States

Location

Local Institution

Rosemead, California, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Atlanta, Georgia, United States

Location

Local Institution

Macon, Georgia, United States

Location

Local Instituton

Hoffman Estates, Illinois, United States

Location

Local Institution

Las Vegas, Nevada, United States

Location

Local Institution

Nashua, New Hampshire, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Beachwood, Ohio, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Charleston, South Carolina, United States

Location

Local Institution

Houston, Texas, United States

Location

Local Institution

Milwaukee, Wisconsin, United States

Location

Related Publications (1)

  • Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9. doi: 10.4088/jcp.v68n0115.

    PMID: 17284138DERIVED

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 Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2002

First Posted

May 9, 2002

Study Start

April 1, 2002

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

November 11, 2013

Record last verified: 2007-09

Locations

US(16)