Clinical trial NCT01663532: Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Otsuka America Pharmaceutical
First posted: 2012-08-13
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline to Week 10
Secondary outcomes:
measure: Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
timeFrame: Baseline to Week 10
measure: Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
timeFrame: Baseline to Week 10
measure: Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
timeFrame: Baseline to Week 10
measure: Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.
timeFrame: Week 10
measure: Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.
timeFrame: Week 10
measure: Responder Rate Based on PANSS Total Score.
timeFrame: Week 10
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Carson
country: United States
state: California
city: Escondido
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Marlton
country: United States
state: New Jersey
city: Holliswood
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Popovaca
country: Croatia
city: Zagreb
country: Croatia
city: Daugavpils
country: Latvia
city: Jelgava
country: Latvia
city: Liepaja
country: Latvia
city: Strenci
country: Latvia
Study officials:
References:
citation: 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.