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NCT00731549 · ClinicalTrials.gov registry record · Phase 3

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

A Phase 3 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
1,081
Enrollment target
20
Study locations

NCT00731549: Completed Phase 3 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT00731549 is a Phase 3 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,081 participants, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (400% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00731549, a Phase 3 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
1,081 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Primary Outcome

"Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression

Conditions Studied

Schizophrenia

Interventions

  • DRUG Aripiprazole IM Depot

Study Locations (20)

California

  • - Anaheim
  • - Cerritos
  • - Chino
  • - Escondido
  • - Garden Grove
  • - Glendale
  • - Glendale
  • - Imperial
  • - La Habra
  • - Los Angeles
  • - National City
  • - Oceanside
  • - Orange
  • - Pasadena
  • - Pico Rivera
  • - San Bernardino
  • - San Diego
  • - San Diego
  • Study Site - San Diego

Arizona

  • - Chandler

Trial Details

FieldValue
Enrollment Target 1,081 participants
Start Date 2008-12
Est. Completion 2013-11
Phase Phase 3
Otsuka Pharmaceutical Development & Commercialization

221 total trials

What the finished NCT00731549 record still lists

NCT00731549 is an interventional study that assigns participants to a tested intervention. Its 1,081 participants enrollment target places it among the larger protocols in the corpus, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (400% higher).

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Aripiprazole IM Depot is the first listed.

NCT00731549 names 20 study sites across 2 states, led by California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00731549 about?

NCT00731549 is a clinical study titled "Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia". To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

What is the current status of trial NCT00731549?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,081 participants. The study started on 2008-12. Estimated completion is 2013-11.

What conditions does trial NCT00731549 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT00731549?

The interventions under investigation include: Aripiprazole IM Depot (DRUG).

Who is sponsoring clinical trial NCT00731549?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00731549 being conducted?

This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00731549's enrollment target sits among peer trials

1,081 7th of 315 higher than 309 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00731549, the US trial registry maintained by the National Library of Medicine. NCT00731549 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.