Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

NCT03172871 | Completed Phase 3

• 1 other identifier: 031-403-00048
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Aripiprazole Intramuscular Depot; Acute treatment

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline to endpoint(10th week)in PANSS Total Score.

  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.

  1st,2nd,4th,6th,8th,10th,12th week

Study Arms (2)

Aripiprazole IM Depot

EXPERIMENTAL

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)

Drug: Aripiprazole IM Depot; Drug: Aripiprazole tablet

Aripiprazole tablet

ACTIVE COMPARATOR

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

Drug: Aripiprazole IM Depot; Drug: Aripiprazole tablet

Interventions

Aripiprazole IM Depot DRUG

Aripiprazole IM depot 400 mg/300 mg (when not tolerated)

Also known as: Aripiprazole Intramuscular Depot

Aripiprazole IM Depot; Aripiprazole tablet

Aripiprazole tablet DRUG

Oral aripiprazole tablets 10 to 20 mg daily

Also known as: Aripiprazole TAB

Aripiprazole IM Depot; Aripiprazole tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Woman and men subjects with Child-bear potential, unwilling or unable to take effective contraception within 1 year after signing informed consent form.
• Women who are pregnant or breastfeeding.
• Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments.
• Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized \> 5 days for the current acute episode at the time of the screening visit (ie, signing the informed consent).
• Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate trials with different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a history of response to clozapine treatment only.
• Subjects with a current Axis I (DSM-IV-TR) diagnosis other than schizophrenia including, but not limited to:
• Delirium, dementia, amnesic or other cognitive disorder MDD, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder Eating disorder (including anorexia nervosa or bulimia) Obsessive compulsive disorder Panic disorder Post-traumatic stress disorder
• Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
• Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
• Subjects who present a serious risk of suicide, as follows:
• Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide.
• Subjects with clinically significant tardive dyskinesia, as determined by a score of ≥ 3 on Item 8 of the AIMS at the screening visit.
• Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
• Subjects who have met DSM-IV-TR criteria for substance abuse with the past 3 months prior to screening or dependence within the past 6 months; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
• Subjects who have a history or severe organic disease of vital organs (including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease ).

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

• Xiao L, Zhao Q, Li AN, Sun J, Wu B, Wang L, Zhang H, Zhang R, Li K, Xu X, Liu T, Zhang W, Xie S, Xu X, Tan Y, Zhang K, Zhang H, Guan N, Xian M, Uki M, Wang G. Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study. Psychopharmacology (Berl). 2022 Jan;239(1):243-251. doi: 10.1007/s00213-021-06044-x. Epub 2022 Jan 6.

  PMID: 34989824 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

Study Officials

• Patyman Juma

  Otsuka Beijing Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 1, 2017
• Study Start: May 15, 2017
• Primary Completion: July 22, 2019
• Study Completion: September 30, 2019
• Last Updated: December 29, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)