Clinical trial NCT01683058: Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Official title: A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Otsuka America Pharmaceutical
First posted: 2012-09-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
* Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
* Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
* Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
* Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
* Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.

Exclusion Criteria:

* Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active Women of Childbearing Potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
* Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
* Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
* Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
* Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291.
* Subjects likely to require prohibited concomitant therapy during the trial
* Laboratory test and ECG results which are exclusionary
* Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial

Primary outcomes:
measure: Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)
timeFrame: Baseline to Week 24
measure: Mean Change in Body Temperature From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Heart Rate Supine From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Diastolic Supine BP From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Heart Rate From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Systolic BP From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Diastolic BP From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Ventricular Rate From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in PR Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in RR Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in QRS Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in QT Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in QTcB Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in QTcF Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in QTcN Interval From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.
timeFrame: Baseline to last visit
measure: Number of Participants With Clinically Relevant Laboratory Values.
timeFrame: Baseline to last visit
measure: Number of Participants With Clinically Relevant Physical Examination.
timeFrame: Baseline to last visit
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Carson
country: United States
state: California
city: Escondido
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Long Beach
country: United States
state: California
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Marlton
country: United States
state: New Jersey
city: Holliswood
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Popovaca
country: Croatia
city: Zagreb
country: Croatia
city: Daugavpils
country: Latvia
Study officials:
References: