Phase 3
Completed N=464
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
Bipolar I
Source: ClinicalTrials.gov NCT01710709 ↗
Enrolled (actual)
464
Serious AEs
6.5%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Adverse Events — 374; 374; 30; 41 Participants
◆ Published Evidence
Emerging
19citations · ~2 / year
Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study.
Summary
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.
Linked Publications (2)
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Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study.
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Safety and Efficacy of Maintenance Treatment With Aripiprazole Once-Monthly in Black/African American Adults Diagnosed With Bipolar I Disorder: Post Hoc Analysis of a 52-Week, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
374; 374; 30; 41; 47; 48 | — |
| PRIMARY Injection Site Pain Measured by the Visual Analog Scale (VAS) |
4.9; 4.1; 3.4; 3.6; 2.9; 2.4 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormal Laboratory Test Results |
53; 39; 32; 124 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormal Vital Signs |
93; 66; 4; 3; 2; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs) |
9; 8; 4; 2 | — |
| PRIMARY Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS) |
0.07; 0.05; 0.21; 0.20; 0.32; 0.21 | — |
| PRIMARY Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 3; 4; 46; 4 | — |
| PRIMARY Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating |
2; 1; 1; 2; 34; 4 | — |
| SECONDARY Percentage of Participants Who Remained Stable at End of Treatment in Phase C |
100.00; 96.98; 97.22; 95.64; 96.31; 96.46 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01710709) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.