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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Bipolar I

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01710709

31-08-252

Details and patient eligibility

About

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.

Full description

This will be an open-label, uncontrolled study which will enroll subjects completing Study 31-08-250 and new subjects. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e 31-08-250).

This open-label study will be comprised of phases similar to the pivotal double-blind study (i.e. Study 250): a screening phase (if applicable), a conversion phase (Phase A, if applicable), an oral stabilization phase (Phase B, if applicable), and an IM depot open-label maintenance phase (Phase C). Phase C will be a minimum of 28 weeks up to a 52-week treatment period with a 4 week follow up period.

During Phase C (the open-label maintenance phase) rescue medication will be allowed for subjects who do not meet stability criteria. This analysis focuses on Phase C due to ClinicalTrials.gov system limitations.

Enrollment

748 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed participation in Trial 31-08-250
De novo subjects not participating in Trial 31-08-250
Subjects who are able to provide written informed consent.
Male and female subjects 18 years of age or older at time of informed consent
Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication for their bipolar I disorder and would benefit from extended treatment with a long-acting injectable formulation
Subjects who have a recurrence of mood episode or exacerbations of mood symptoms when they are not receiving treatment for their bipolar I disorder or are noncompliant with treatment for their bipolar I disorder
Have an outpatient status

Exclusion criteria

Experienced 9 or more mood episodes within the past year
A current manic episode with a duration of > 2 years
Currently meet DSM-IV-TR criteria for substance abuse or substance dependence; this includes the abuse of alcohol and benzodiazepines, but excludes the use of caffeine and/or nicotine
Hypothyroidism or hyperthyroidism, unless condition has been stabilized
Diagnosed with epilepsy or a history of seizures
Known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones
Sexually active women of childbearing potential and sexually active men who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this trial and for 180 days following the last dose of trial medication
Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
Risk of committing suicide
Abnormal laboratory test results, vital signs and ECG results
Participated in any clinical trial other than Trial 250 with an investigational agent within the 30 days prior to screening
Had electroconvulsive therapy (ECT) treatment during the current episode or within 3 months
Subjects who have not met criteria for stabilization for 4 consecutive weeks