Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

NCT01663532 | Completed Phase 3 Results

• 1 other identifier: 31-12-291
• Study Type: interventional
• Target: 340
• Locations: 3 countries
• Sites: 49

Brief Summary

The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia. The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.

  The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.

  Baseline to Week 10

Secondary Outcomes (6)

• Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.

  Baseline to Week 10

• Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.

  Baseline to Week 10

• Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.

  Baseline to Week 10

• Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.

  Week 10

• Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.

  Week 10

Study Arms (2)

Aripiprazole IM Depot

EXPERIMENTAL

Aripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks

Drug: Aripiprazole IM Depot

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Aripiprazole IM Depot DRUG

Also known as: OPC-14597, Lu AF41155

Aripiprazole IM Depot

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
• Subjects with a diagnosis of schizophrenia for at least 1 year as defined by DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.
• Subjects with a stable living environment when not in hospital.
• Subjects who would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry.
• Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting BOTH of the following at screening and baseline:
• Currently experiencing an acute exacerbation of psychotic symptoms accompanied by significant deterioration in the subject's clinical and/or functional status from their baseline clinical presentation with a Positive and Negative Syndrome Scale (PANSS) Total Score ≥ 80 AND
• Specific psychotic symptoms on the PANSS as measured by a score of \> 4 on each of the following items (possible scores of 1 to 7 for each item)
• Conceptual disorganization (P2)
• Hallucinatory behavior (P3)
• Suspiciousness/persecution (P6)
• Unusual thought content (G9)
• Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration and who showed a previous good response to such antipsychotic treatment (other than clozapine) in last 12 months.
• Subjects with a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding current episode.
• Subjects willing to discontinue all prohibited psychotropic medications to meet protocol required washouts prior to and during trial period.
• BMI less ≤ 40 kg/m2 (morbid obesity) at screening.

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 last dose of trial medication. Sexually active females 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 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 with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments. - Subjects presenting with a first episode of schizophrenia - Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized \> 5 days for current acute episode at the time of screening visit
• Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment Subjects who have a history of response to clozapine treatment only.
• Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder or mental retardation.
• Subjects experiencing acute depressive symptoms within past 30 days that require treatment with an antidepressant.
• Subjects with a significant risk of violent behavior; who represent a risk of committing suicide as indicated by any suicidal ideation within the last 1 month or any suicidal behaviors within the last year; or who present a serious risk of suicide.
• Subjects with clinically significant tardive dyskinesia,.
• Subjects with severe akathisia.
• Subjects who have met DSM-IV-TR criteria for substance abuse with past 3 months prior to screening or dependence within past 6 months; including alcohol and benzodiazepines, but excluding caffeine and nicotine.

Sponsors & Collaborators

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

Study Sites (49)

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Little Rock, Arkansas, 72201, United States

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Springdale, Arkansas, 72764, United States

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Anaheim, California, 92805, United States

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Carson, California, 90746, United States

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Escondido, California, 92025, United States

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Long Beach, California, 90806, 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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Oceanside, California, 92056, 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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Denver, Colorado, 80209, United States

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

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Bradenton, Florida, 34208, 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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Hollywood, Florida, 33021, United States

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Kissimmee, Florida, 34741, 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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Saint Charles, Missouri, 63304, 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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St Louis, Missouri, 63141, 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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Charleston, South Carolina, 29407, 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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Salt Lake City, Utah, 84106, United States

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Popovača, 44317, Croatia

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Zagreb, 10090, Croatia

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Daugavpils, LV-5417, Latvia

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Jelgava, LV-3008, Latvia

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Liepāja, LV-3401, Latvia

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Strenči, LV-4730, Latvia

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Related Publications (1)

• Kane JM, Peters-Strickland T, Baker RA, Hertel P, Eramo A, Jin N, Perry PP, Gara M, McQuade RD, Carson WH, Sanchez R. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Nov;75(11):1254-60. doi: 10.4088/JCP.14m09168.

  PMID: 25188501 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2015-02

Locations

CR (2); LA (4); US (43)