Clinical trial NCT01909466: Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Official title: An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Mental Disorder
Nervous System Diseases
Keywords: OPC-14597
Aripiprazole
Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2013-07-26
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a trial designed to assess the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day followup. The trial population will include male and female subjects between 18 and 64 years (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a prior history of tolerating aripiprazole per investigator's judgement.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs).
timeFrame: AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last
measure: Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.
timeFrame: Days 1 and 113
measure: Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).
timeFrame: Baseline to Last Visit (Day 141)
measure: Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).
timeFrame: Baseline to Week 20
Secondary outcomes:
measure: Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in PANSS Positive Sub-scale Score.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in PANSS Negative Sub-scale Score.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.
timeFrame: Baseline to Week 20
measure: Clinical Global Impression-Improvement (CGI-I) Score.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).
timeFrame: Baseline to Week 20+
measure: Mean Change From Baseline in Mental Functioning Score of SWN-S.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Self Control Score of SWN-S.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Physical Functioning Score of SWN-S.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Emotional Regulation Score of SWN-S.
timeFrame: Baseline to Week 20
measure: Mean Change From Baseline in Social Integration Score of SWN-S.
timeFrame: Baseline to Week 20
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Comprehensive Clinical Development
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: San Diego
country: United States
facility: CNRI-San Diego
state: California
city: Washington
country: United States
facility: Comprehensive Clinical Development
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Leesburg
country: United States
facility: Compass Research North, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: St. Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Marlton
country: United States
facility: CRI Lifetree
state: New Jersey
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Kimberly Largay, MD
role: STUDY_DIRECTOR
References:
citation: Raoufinia A, Peters-Strickland T, Nylander AG, Baker RA, Eramo A, Jin N, Bricmont P, Repella J, McQuade RD, Hertel P, Larsen F. Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration. Int J Neuropsychopharmacol. 2017 Apr 1;20(4):295-304. doi: 10.1093/ijnp/pyw116.