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

NCT ID: NCT01663532

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aripiprazole IM Depot

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

Group Type: EXPERIMENTAL

Aripiprazole IM Depot

Intervention Type: DRUG

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

Aripiprazole IM Depot

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Other Intervention Names

OPC-14597; Lu AF41155

Eligibility Criteria

Inclusion Criteria

• 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.
• Subjects who are able to provide written informed consent.
• Ability to understand the nature of trial and follow protocol requirements.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Anaheim, California, United States

Carson, California, United States

Escondido, California, United States

Long Beach, California, United States

Long Beach, California, United States

National City, California, United States

Oakland, California, United States

Oceanside, 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

Denver, Colorado, United States

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

Bradenton, Florida, United States

Fort Lauderdale, Florida, United States

Fort Lauderdale, Florida, United States

Fort Lauderdale, Florida, United States

Hollywood, Florida, United States

Kissimmee, 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

Saint Charles, Missouri, United States

St Louis, Missouri, 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

Charleston, South Carolina, United States

Austin, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Popovača, , Croatia

Zagreb, , Croatia

Daugavpils, , Latvia

Jelgava, , Latvia

Liepāja, , Latvia

Strenči, , Latvia

Countries

United States; Croatia; Latvia

References

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.

Reference Type: DERIVED

PMID: 25188501 (View on PubMed)

Other Identifiers

31-12-291

Identifier Type: -

Identifier Source: org_study_id