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CompletedNCT00036127Updated Nov 11, 2013

Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

A Phase 2/3 interventional study of aripiprazole in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-11.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

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Keywords

  • agitated schizophrenic patients
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

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Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Agitated schizophrenic patients
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment

Interventions

  • Drugaripiprazole
06

Study locations

16 sites
  • Local Institution
    Anaheim, California, United States
  • Local Institution
    Cerritos, California, United States
  • Local Institution
    Chula Vista, California, United States
  • Local Institution
    Rosemead, California, United States
  • Local Institution
    San Diego, California, United States
  • Local Institution
    Atlanta, Georgia, United States
  • Local Institution
    Macon, Georgia, United States
  • Local Instituton
    Hoffman Estates, Illinois, United States
  • Local Institution
    Las Vegas, Nevada, United States
  • Local Institution
    Nashua, New Hampshire, United States
  • Local Institution
    New York, New York, United States
  • Local Institution
    Beachwood, Ohio, United States
  • Local Institution
    Philadelphia, Pennsylvania, United States
  • Local Institution
    Charleston, South Carolina, United States
  • Local Institution
    Houston, Texas, United States
  • Local Institution
    Milwaukee, Wisconsin, United States
07

References and documents

Publications

  • 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. PubMed 17284138 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00036127
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
First posted
May 9, 2002
Start date
Apr 2002
Primary completion
Jan 2003
Completion
Jan 2003
Last update
Nov 11, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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