Phase 3
Completed N=1,081
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00731549 ↗Enrolled (actual)
1,081
Serious AEs
8.8%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). — 100; 99.02; 99.14; 98.51 Percentage of participants
Summary
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit). |
100; 99.02; 99.14; 98.51; 97.47; 98.42 | — |
| SECONDARY Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria. |
0.49; 0.48; 0.79; 1.52; 0.84; 1.09 | — |
| SECONDARY Percentage of Participants Achieving Remission. |
51.7 | — |
| SECONDARY Percentage of Participants Stable at Baseline and Remaining Stable at Week 28. |
100; 98.95 | — |
| SECONDARY Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse. |
8.2 | — |
| SECONDARY Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score. |
-1.69; -2.55; -3.55; -1.72 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score. |
-0.11; -0.17; -0.24; -0.14 | — |
| SECONDARY Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales. |
-0.42; -0.68; -1.04; -0.49; -0.40; -0.53 | — |
| SECONDARY Mean Clinical Global Impression of Improvement (CGI-I) Score. |
3.48; 3.52; 3.49; 3.42; 3.33; 3.25 | — |
| SECONDARY Percentage of Participants Who Discontinued Due to All Causes. |
20.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
- Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
- Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
- # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
- Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
Exclusion Criteria
- Subjects 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. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
- Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
- Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
- Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
- Subjects with a history of hypersensitivity to antipsychotic agents.
- Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Data sourced from ClinicalTrials.gov (NCT00731549). 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.