NCT01663532CompletedPhase 3
A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.0 sites340 target enrollmentStarted: October 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 340
- Primary Endpoint
- Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Aripiprazole IM Depot (Drug)
Placebo
Placebo Comparator
Matching placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Time Frame: Baseline to Week 10
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.
Secondary Outcomes
- Responder Rate Based on PANSS Total Score.(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 Clinical Global Impression-Severity Scale (CGI-S) Score.(Baseline to Week 10)
- Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.(Week 10)
- Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.(Week 10)
Investigators
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