Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

ClinicalTrials.gov ID: NCT01710709

Public ClinicalTrials.gov record NCT01710709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 24, 2026, 5:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

Study identification

NCT ID: NCT01710709
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 748 participants

Conditions and interventions

Conditions

Bipolar I

Interventions

Aripiprazole Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2012 (Type not available)
Primary completion: Nov 2016 (Actual)
Completion: Dec 2016 (Actual)
Last update posted: Sep 21, 2018

2012 – 2016

United States locations

U.S. sites: 72
U.S. states: 26
U.S. cities: 65

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35226	—
Not listed	Little Rock	Arkansas	72211	—
Not listed	Rogers	Arkansas	72758	—
Not listed	Bellflower	California	90706	—
Not listed	Beverly Hills	California	90210	—
Not listed	Costa Mesa	California	92626	—
Not listed	Culver City	California	90230	—
Not listed	Garden Grove	California	92845	—
Not listed	Lemon Grove	California	91945	—
Not listed	Oakland	California	94607	—
Not listed	Orange	California	92868	—
Not listed	Pico Rivera	California	90660	—
Not listed	Riverside	California	92506	—
Not listed	San Diego	California	92102	—
Not listed	Temecula	California	92591	—
Not listed	Upland	California	91786	—
Not listed	Wildomar	California	92595	—
Not listed	Colorado Springs	Colorado	80910	—
Not listed	Gainesville	Florida	32607	—
Not listed	Hialeah	Florida	33012	—
Not listed	Jacksonville	Florida	32256	—
Not listed	Leesburg	Florida	34748	—
Not listed	Orlando	Florida	32801	—
Not listed	Tampa	Florida	33613	—
Not listed	Atlanta	Georgia	30331	—
Not listed	Decatur	Georgia	30030	—
Not listed	Smyrna	Georgia	30080	—
Not listed	Chicago	Illinois	60611	—
Not listed	Chicago	Illinois	60612	—
Not listed	Hinsdale	Illinois	60522	—
Not listed	Naperville	Illinois	60563	—
Not listed	Schaumburg	Illinois	60194	—
Not listed	Prairie Village	Kansas	66206	—
Not listed	Lake Charles	Louisiana	70629	—
Not listed	Baltimore	Maryland	21208	—
Not listed	Gaithersburg	Maryland	20877	—
Not listed	Boston	Massachusetts	02131	—
Not listed	O'Fallon	Missouri	63368	—
Not listed	St Louis	Missouri	63128	—
Not listed	Lincoln	Nebraska	68526	—
Not listed	Berlin	New Jersey	08009	—
Not listed	Cherry Hill	New Jersey	08002	—
Not listed	Brooklyn	New York	11241	—
Not listed	Buffalo	New York	14215	—
Not listed	New York	New York	10003	—
Not listed	New York	New York	10023	—
Not listed	Rochester	New York	14615	—
Not listed	Rochester	New York	14618	—
Not listed	Staten Island	New York	10305	—
Not listed	Staten Island	New York	10312	—
Not listed	Cincinnati	Ohio	45219	—
Not listed	Oklahoma City	Oklahoma	73103	—
Not listed	Oklahoma City	Oklahoma	73112	—
Not listed	Oklahoma City	Oklahoma	73118	—
Not listed	Portland	Oregon	97210	—
Not listed	Allentown	Pennsylvania	18104	—
Not listed	Media	Pennsylvania	19063	—
Not listed	Columbia	South Carolina	29201	—
Not listed	Memphis	Tennessee	38119	—
Not listed	Arlington	Texas	76012	—
Not listed	Austin	Texas	78754	—
Not listed	Dallas	Texas	75243	—
Not listed	Plano	Texas	75074	—
Not listed	Plano	Texas	75093	—
Not listed	Sugar Land	Texas	77478	—
Not listed	Wichita Falls	Texas	76309	—
Not listed	Orem	Utah	84058	—
Not listed	Salt Lake City	Utah	84106	—
Not listed	Richmond	Virginia	23230	—
Not listed	Bellevue	Washington	98007	—
Not listed	Spokane	Washington	99204	—
Not listed	Middleton	Wisconsin	53562	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01710709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 21, 2018 · Synced Oct 24, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01710709 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →