Effectiveness of an Intramuscular Formuation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
- Conditions
- Bipolar I disorderMedDRA version: 16.1Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-004334-42-HU
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria Assessed Prior to Entry into Phase C
1. Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requires consent by a legally acceptable representative (LAR) in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
2. Male and female subjects 18 years of age or older at time of informed consent.
3. Subjects who have completed Trials 250 and did not meet the criteria for recurrence of mood episode at the End of Trial Visit.
4. 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 longacting injectable formulation.
5. In the investigator’s opinion, subjects who are able to understand the nature of this trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales.
Inclusion Criteria - Entry For De novo Subjects
Screening
1. Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requires consent by a legally acceptable representative (LAR) in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
2. Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
3. Subjects with a current diagnosis of bipolar I disorder, as defined by DSM-IV-TR criteria and confirmed by the MINI and a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer and/or treatment with an antipsychotic agent. Require” is defined as an intervention that occurred rather than one that was recommended. Rapid cyclers with 8 or fewer episodes in the previous year will be included.
5. Subjects who, in the investigator’s judgment, require treatment with an antipsychotic medication for their bipolar I disorder and would benefit from treatment with a long-acting injectable formulation.
6. Subjects who have had 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.
7. In the investigator’s opinion, subjects who are able to understand the nature of this trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales.
Inclusion Criteria Assessed Prior to Entry into Phase A
8. Subjects with an adequate washout of prohibited/restricted concomitant medication.
9. Subjects who have an outpatient status.
Inclusion Criteria Assessed Prior to Entry into Phase B
10. Subjects with an adequate washout of prohibited/restricted concomitant medication.
11. Phase A subje
1. Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar I disorder, including schizophrenia, schizoaffective disorder, major depressive disorder, attention-deficit/hyperactivity disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. All other current diagnoses must be discussed with the medical monitor.
2. Subjects who have experienced 9 or more mood episodes within the past year.
3. Subjects who have NOT experienced at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer and/or treatment with antipsychotic agent. Require” is defined as an intervention that occurred rather than one that was recommended.
4. Subjects with a current manic episode with a duration of > 2 years.
5. Subjects who are currently experiencing a depressive episode (per DSM-IV-TR criteria).
6. Subjects with bipolar I disorder who are considered resistant/refractory to treatment for manic symptoms by history.
7. Subjects unresponsive to clozapine for treatment of mania.
8. Subjects who only respond to clozapine for treatment of mania.
9. Subjects with a significant risk of committing suicide based on history, mental status examination, investigator’s judgment, or C-SSRS answer of yes” to questions 4 or 5 (current or within the last 90 days).
10. Subjects who currently (within the past month)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.
11. Subjects with hypothyroidism or hyperthyroidism and/or other unstable thyroid pathology, unless condition has been stabilized with medications for at least the past 3 months.
12. Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course
of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator.
13. Subjects with epilepsy or a history of seizures (except for a single childhood febrile seizure, post traumatic, alcohol withdrawal, etc).
14. Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
15. Subjects likely to require prohibited concomitant therapy during this trial.
16. Subjects who may require cytochrome P450 (CYP) 2D6 or CYP3A4 inhibitors, or CYP3A4 inducers during this trial (see Table 4.2.1-1).
17. Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
18. Subjects with a history of hypersensitivity to antipsychotic agents.
19. Subjects deemed intolerant of receiving injectable treatment.
20. Sexually active women of childbearing potential (WOCBP) who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this trial and for 150 days following the last dose of trial medication.
- Abstinence will be permitted if it is confirmed and documented at every trial visit.
- If employing birth control, 2 of the following prec
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method