Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Aripiprazole IM Depot	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

Treatment-emergent AEs (TEAEs) by severity [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects reporting Treatment-emergent AEs (TEAEs) by severity
Treatment-emergent AEs potentially causally related to the IMP [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of Subjects reporting Treatment-emergent AEs potentially causally related to the IMP
Treatment-emergent AEs with an outcome of death [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects with Treatment-emergent AEs with an outcome of death
Serious TEAEs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects reporting Serious Treatment Emergent Adverse Events
Discontinuations due to TEAEs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
% of subjects discontinuing due to Treatment Emergent Adverse Events

Secondary Outcome Measures:

Suicide risk as assessed and classified by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Change in C-SSRS scores from baseline to end of study
Extrapyramidal symptoms evaluated using the Simpson-Angus Scale (SAS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Change from baseline on Simpson-Angus Scale
Extrapyramidal symptoms evaluated using the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Change from baseline on Abnormal Involuntary Movement Scale (AIMS)
Extrapyramidal symptoms evaluated using Barnes Akathisia Rating Scale (BARS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Change from baseline on Barnes Akathisia Rating Scale (BARS)
% of subjects with clinically relevant Vital Signs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects with clinically relevant Vital Signs
% of subjects with clinically relevant ECGs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects with clinically relevant ECGs
% of subjects with clinically relevant body weight changes [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects with clinically relevant body weight changes
Physical Examination Findings [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of patients with clinically relevant physical examination findings
Lab Values [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
% of subjects with clinically relevant Lab values

Estimated Enrollment:	125
Study Start Date:	January 2013
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aripiprazole IM Depot Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks	Drug: Aripiprazole IM Depot Aripiprazole IM Depot 400 mg or 300 mg

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683058

Contacts

Contact: Atlantis Schizophrenia

Otsuka@quintiles.com

Locations

United States, Arkansas
	Recruiting
Springdale, Arkansas, United States, 72764
United States, California
	Recruiting
Carson, California, United States, 90746
	Recruiting
Escondido, California, United States, 92025
	Recruiting
Garden Grove, California, United States, 92845
	Recruiting
Long Beach, California, United States, 90813
	Recruiting
Oakland, California, United States, 94612
	Recruiting
Pico Rivera, California, United States, 90660
	Recruiting
San Diego, California, United States, 92102
	Recruiting
Santa Ana, California, United States, 92701
	Recruiting
Sherman Oaks, California, United States, 91403
United States, District of Columbia
	Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
	Recruiting
Ft. Lauderdale, Florida, United States, 33308
	Recruiting
Ft. Lauderdale, Florida, United States, 33301
	Recruiting
Kissimmee, Florida, United States, 34741
	Recruiting
North Miami, Florida, United States, 33162
	Recruiting
Orlando, Florida, United States, 32810
United States, Georgia
	Recruiting
Atlanta, Georgia, United States, 30308
United States, Illinois
	Recruiting
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
	Recruiting
Lake Charles, Louisiana, United States, 70629
United States, Missouri
	Recruiting
St Louis, Missouri, United States, 63128
	Recruiting
St. Louis, Missouri, United States, 63118
United States, New Jersey
	Recruiting
Marlton, New Jersey, United States, 08053
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
	Recruiting
Austin, Texas, United States, 78754
	Recruiting
Dallas, Texas, United States, 75243

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

H. Lundbeck A/S

Otsuka America Pharmaceutical

More Information

No publications provided

Responsible Party:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT01683058 History of Changes
Other Study ID Numbers:	31-12-297
Study First Received:	September 7, 2012
Last Updated:	May 9, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013