A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole IM Depot
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Beijing Research Institute
- Enrollment
- 436
- Locations
- 1
- Primary Endpoint
- Mean change from baseline to endpoint(10th week)in PANSS Total Score.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.
Detailed Description
Screening Phase: The screening phase will begin when informed consent is signed and be a maximum of 13 days. The investigators will assess the subjects who meet all eligibility criteria and collect the characteristic information of the subjects, such as demographic, medical history, etc. If subjects have been exposed to aripiprazole in the past (ie, tolerability has been established), then subjects will enter a washout period for 3～7 days from prior antipsychotic medications and other prohibited concomitant medications. If the investigator may reasonably verify that subject has been off antipsychotics for at least 3～7 days and has a history of tolerating aripiprazole, then the subject may have a screening phase of \< 7 days as long as the subject has had at least a 3～7-day washout phase from other antipsychotic medications. Subjects are required to be hospitalized during the entire screening phase. 12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo. Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent form by subjects and subject's legal guardian or legally acceptable representative.
- •The subjects and subject's legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the schedule visit, report the adverse event and concomitant medication to investigator, and to be reliably rated on psychiatrically scales.
- •Male and female subjects 18 to 65 years of age, at the time of informed consent.
- •Subjects with a diagnosis of schizophrenia 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, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
- •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≥ 70 AND
- •Specific psychotic symptoms on the PANSS as measured by a score of \> 4 on at least two 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)
- •According to the investigator's opinion, subjects who have received antipsychotic treatment (except clozapine) with good response. (this criteria only applicable for the schizophrenia recurrence subject).
- •Subjects willing to discontinue all prohibited psychotropic medications to meet protocol requirements prior to and during the trial period.
Exclusion Criteria
- Not provided
Arms & Interventions
Aripiprazole IM Depot
Aripiprazole IM depot group (Aripiprazole IM Depot): The first 2 weeks of the acute treatment phase IM Injection 400 mg every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase IM Injection 400/300 mg every 4 weeks + placebo（tablets）(once a day)
Intervention: Aripiprazole IM Depot
Aripiprazole IM Depot
Aripiprazole IM depot group (Aripiprazole IM Depot): The first 2 weeks of the acute treatment phase IM Injection 400 mg every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase IM Injection 400/300 mg every 4 weeks + placebo（tablets）(once a day)
Intervention: Aripiprazole tablet
Aripiprazole tablet
Oral aripiprazole group (Aripiprazole tablet): The first 2 weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day
Intervention: Aripiprazole IM Depot
Aripiprazole tablet
Oral aripiprazole group (Aripiprazole tablet): The first 2 weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day
Intervention: Aripiprazole tablet
Outcomes
Primary Outcomes
Mean change from baseline to endpoint(10th week)in PANSS Total Score.
Time Frame: 1st,2nd,4th,6th,8th,10th,12th week
The primary efficacy outcome variable is mean change from baseline to endpoint (Week 10) in PANSS Total Score. The objective of the primary analysis is to compare the efficacy of aripiprazole IM depot (400 mg or 300 mg) with that of placebo with regard to mean change from baseline to endpoint (Week 10) in PANSS Total Score.