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NCT00705783 · 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
843
Enrollment target
20
Study locations

NCT00705783 is a Phase 3 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 843 participants, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (290% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT00705783, a Phase 3 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
843 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.

Conditions Studied

Schizophrenia

Interventions

  • DRUG Aripiprazole depot
  • DRUG Placebo depot

Study Locations (20)

Florida

  • Otsuka Investigational Site - Altamonte Springs
  • Otsuka Investigational Site - Bradenton
  • Otsuka Investigational Site - Hollywood
  • Otsuka Investigational Site - Maitland
  • Otsuka Investigational Site - Miami
  • Otsuka Investigational Site - North Miami
  • Otsuka Investigational Site - Orange City
  • Otsuka Investigational Site - Tampa

California

  • Otsuka Investigational Site - Anaheim
  • Otsuka Investigational Site - National City
  • Otsuka Investigational Site - Oceanside
  • Otsuka Investigational Site - San Diego
  • Otsuka Investigational Site - Santa Ana

Arizona

  • Otsuka Investigational Site - Chandler

Colorado

  • Otsuka Investigational Site - Highlands Ranch

Connecticut

  • Otsuka Investigational Site - Norwalk

Georgia

  • Otsuka Investigational Site - Atlanta

Illinois

  • Otsuka Investigational Site - Hoffman Estates

Indiana

  • Otsuka Investigational Site - Munster

Trial Details

FieldValue
Enrollment Target 843 participants
Start Date 2008-07
Est. Completion 2011-02
Phase Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00705783

The ClinicalTrials.gov registry entry for NCT00705783 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 843 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (290% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Aripiprazole depot is the first listed.

NCT00705783 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00705783 about?

NCT00705783 is a clinical study titled "Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia". The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted ...

What is the current status of trial NCT00705783?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 843 participants. The study started on 2008-07. Estimated completion is 2011-02.

What conditions does trial NCT00705783 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT00705783?

The interventions under investigation include: Aripiprazole depot (DRUG), Placebo depot (DRUG).

Who is sponsoring clinical trial NCT00705783?

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

Where is trial NCT00705783 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.