Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01683058
First received: September 7, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.


Condition Intervention Phase
Schizophrenia
Drug: Aripiprazole IM Depot
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Treatment-emergent AEs (TEAEs) by severity [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects reporting Treatment-emergent AEs (TEAEs) by severity

  • Treatment-emergent AEs potentially causally related to the IMP [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of Subjects reporting Treatment-emergent AEs potentially causally related to the IMP

  • Treatment-emergent AEs with an outcome of death [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects with Treatment-emergent AEs with an outcome of death

  • Serious TEAEs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects reporting Serious Treatment Emergent Adverse Events

  • Discontinuations due to TEAEs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    % of subjects discontinuing due to Treatment Emergent Adverse Events


Secondary Outcome Measures:
  • Suicide risk as assessed and classified by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Change in C-SSRS scores from baseline to end of study

  • Extrapyramidal symptoms evaluated using the Simpson-Angus Scale (SAS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Change from baseline on Simpson-Angus Scale

  • Extrapyramidal symptoms evaluated using the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Change from baseline on Abnormal Involuntary Movement Scale (AIMS)

  • Extrapyramidal symptoms evaluated using Barnes Akathisia Rating Scale (BARS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Change from baseline on Barnes Akathisia Rating Scale (BARS)

  • % of subjects with clinically relevant Vital Signs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects with clinically relevant Vital Signs

  • % of subjects with clinically relevant ECGs [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects with clinically relevant ECGs

  • % of subjects with clinically relevant body weight changes [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects with clinically relevant body weight changes

  • Physical Examination Findings [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of patients with clinically relevant physical examination findings

  • Lab Values [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    % of subjects with clinically relevant Lab values


Enrollment: 74
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole IM Depot
Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks
Drug: Aripiprazole IM Depot
Aripiprazole IM Depot 400 mg or 300 mg

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
  • Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
  • Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
  • Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
  • Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
  • Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.

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 the last dose of trial medication. Sexually active Women 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 the 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 experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
  • Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
  • Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
  • Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291.
  • Subjects likely to require prohibited concomitant therapy during the trial
  • Laboratory test and ECG results which are exclusionary
  • Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683058

  Show 38 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Otsuka America Pharmaceutical
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01683058     History of Changes
Other Study ID Numbers: 31-12-297
Study First Received: September 7, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014