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

NCT ID: NCT01683058

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole IM Depot

Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks

Group Type: EXPERIMENTAL

Aripiprazole IM Depot

Intervention Type: DRUG

Aripiprazole IM Depot 400 mg or 300 mg

Interventions

Aripiprazole IM Depot

Aripiprazole IM Depot 400 mg or 300 mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Little Rock, Arkansas, United States

Springdale, Arkansas, United States

Carson, California, United States

Escondido, California, United States

Garden Grove, California, United States

Long Beach, California, United States

National City, California, United States

Oakland, California, United States

Pico Rivera, California, United States

San Diego, California, United States

San Diego, California, United States

Santa Ana, California, United States

Sherman Oaks, California, United States

Washington D.C., District of Columbia, United States

Fort Lauderdale, Florida, United States

Fort Lauderdale, Florida, United States

Fort Lauderdale, Florida, United States

Kissimmee, Florida, United States

North Miami, Florida, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Hoffman Estates, Illinois, United States

Lake Charles, Louisiana, United States

Flowood, Mississippi, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

Marlton, New Jersey, United States

Holliswood, New York, United States

Dayton, Ohio, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Popovača, , Croatia

Zagreb, , Croatia

Daugavpils, , Latvia

Countries

United States; Croatia; Latvia

Other Identifiers

31-12-297

Identifier Type: -

Identifier Source: org_study_id