Phase 1 N=141 Randomized Treatment

Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

Schizophrenia · Mental Disorder · Nervous System Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01909466 ↗

Enrolled (actual)

141

Serious AEs

2.9%

Results posted

Jun 2015

Primary outcome: Primary: Number of Participants With Adverse Events (AEs). — 112; 4; 112; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Aripiprazole, OPC-14597 (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs).	112; 4; 112; 2	—
PRIMARY Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.	2.0; 1.2	—
PRIMARY Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).	0.0; 0.0; 0.0; 0.2; 0.1; 0.1	—
PRIMARY Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).	0.01; 0.04; -0.02; 0.01; 0.02; 0.04	—
PRIMARY Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).	-0.03; -0.05; -0.01; -0.03; -0.05; 0.00	—
PRIMARY Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).	0.03; 0.08; 0.08; 0.06; 0.11; 0.06	—
SECONDARY Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).	-0.94; -2.23	—
SECONDARY Mean Change From Baseline in PANSS Positive Sub-scale Score.	-0.14; -0.52	—
SECONDARY Mean Change From Baseline in PANSS Negative Sub-scale Score.	-0.30; -0.33	—
SECONDARY Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.	-0.02; -0.09	—
SECONDARY Clinical Global Impression-Improvement (CGI-I) Score.	3.86; 3.70	—
SECONDARY Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).	-1.17; -0.81	—
SECONDARY Mean Change From Baseline in Mental Functioning Score of SWN-S.	-0.18; 0.01	—
SECONDARY Mean Change From Baseline in Self Control Score of SWN-S.	-0.47; -0.64	—
SECONDARY Mean Change From Baseline in Physical Functioning Score of SWN-S.	-0.39; -0.37	—
SECONDARY Mean Change From Baseline in Emotional Regulation Score of SWN-S.	0.30; 0.46	—
SECONDARY Mean Change From Baseline in Social Integration Score of SWN-S.	-0.47; -0.32	—

Summary

To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia

Eligibility Criteria

Inclusion Criteria

Male and female individuals between 18 and 64 years, inclusive, at the time of informed consent.
Prior history of tolerating aripiprazole per investigator's judgement.

Exclusion Criteria

Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
Subjects who use more than one antipsychotic medication at screening.
Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
Subjects currently in an acute relapse of schizophrenia.
Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
Subjects who are considered treatment-resistant to antipsychotic medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01909466). 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.