Phase 3
Completed N=709
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
Source: ClinicalTrials.gov NCT01129882 ↗Enrolled (actual)
709
Serious AEs
8.7%
Results posted
Jan 2020
Primary outcomePrimary: Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) — 50 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) |
50 | — |
| SECONDARY Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit |
-0.14 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
- Participants who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.
- The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which was defined as 28 [-2/+10] days) of the last injection in Study 248.
- Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.
- Participants able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.
- Outpatient status.
Exclusion Criteria
- Participants with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders.
- Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
- Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
- Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
- Electroconvulsive therapy within 180 days prior to entry.
- Any participant who requires or may need any other antipsychotic medications during the course of the study.
- Aripiprazole IM Depot (including generic formulation) is commercially available in the participant's country.
- Other protocol specific inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01129882). 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.