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

NCT01683058 | Completed Phase 3 Results

• 1 other identifier: 31-12-297
• Study Type: interventional
• Target: 74
• Locations: 3 countries
• Sites: 38

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

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

  A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.

  Baseline to Week 24

Secondary Outcomes (24)

• Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)

  Baseline to Week 24

• Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)

  Baseline to Week 24

• Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)

  Baseline to Week 24

• Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)

  Baseline to Week 24

• Mean Change in Body Temperature From Baseline in All Participants.

  Baseline to last visit

Study Arms (1)

Aripiprazole IM Depot

EXPERIMENTAL

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

Drug: Aripiprazole IM Depot

Interventions

Aripiprazole IM Depot DRUG

Aripiprazole IM Depot 400 mg or 300 mg

Aripiprazole IM Depot

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator
• Otsuka America Pharmaceutical: collaborator

Study Sites (38)

Unknown Facility

Little Rock, Arkansas, 72201, United States

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Springdale, Arkansas, 72764, United States

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Carson, California, 90746, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Long Beach, California, 90813, United States

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National City, California, 91950, United States

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Oakland, California, 94612, United States

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Pico Rivera, California, 90660, United States

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San Diego, California, 92102, United States

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San Diego, California, 92123, United States

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Santa Ana, California, 92701, United States

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Sherman Oaks, California, 91403, United States

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Washington D.C., District of Columbia, 20016, United States

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Fort Lauderdale, Florida, 33301, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Lauderdale, Florida, 33334, United States

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Kissimmee, Florida, 34741, United States

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North Miami, Florida, 33162, United States

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Orlando, Florida, 32810, United States

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Atlanta, Georgia, 30308, United States

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Hoffman Estates, Illinois, 60169, United States

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Lake Charles, Louisiana, 70629, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63118, United States

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St Louis, Missouri, 63128, United States

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Marlton, New Jersey, 08053, United States

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Holliswood, New York, 11423, United States

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Dayton, Ohio, 45417, United States

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Philadelphia, Pennsylvania, 19139, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78754, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75243, United States

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Houston, Texas, 77007, United States

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Popovača, 44317, Croatia

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Zagreb, 10090, Croatia

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Unknown Facility

Daugavpils, LV-5417, Latvia

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 31, 2015
• Results First Posted: March 31, 2015

Record last verified: 2015-03

Locations

CR (2); LA (1); US (35)