An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia (ASPIRE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01129882
First received: May 22, 2010
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or 300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248.


Condition Intervention Phase
Schizophrenia
Drug: Aripiprazole
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: An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency and severity of adverse effects and serious adverse effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    The primary measures are (1) frequency and severity of adverse events, (2) frequency and severity of serious adverse events (including adverse events related to laboratory abnormalities), and (3) rates of discontinuation from study due to adverse events.

    Safety and tolerability data will be summarized as follows: incidence of adverse events and serious adverse events (with severity grades) will be tabulated by MedDRA terms; incidence of discontinuations due to AE will be tabulated by MedDRA terms.



Secondary Outcome Measures:
  • Mean change from baselines [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    Mean change from baseline of vital signs parameters, laboratory tests, and ECG parameters will be provided by visit. Incidence of clinically significant abnormalities in vital signs parameters, laboratory tests, and ECG parameters will be tabulated. Weight gain or loss and injection site reactions will be summarized.

    Mean and mean change from baseline in the efficacy endpoint CGI-S score will be summarized.



Estimated Enrollment: 708
Study Start Date: June 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole IM depot
Active treatment of aripiprazole IM depot (300mg or 400mg)
Drug: Aripiprazole
Aripiprazole IM Depot - 300mg or 400mg

Detailed Description:

This is an open-label study which will enroll subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248 and will continue to provide aripiprazole intramuscular (IM) Depot treatment.

Subjects can receive this treatment until aripiprazole IM Depot is commercially available in any dosage (including generic formulations) in the country that the study is being conducted or the commercial availability of aripiprazole IM Depot is terminated by the sponsor, or until the study end date of 31 Dec 2018 is reached.

Eligible subjects will enter this study at the End of Treatment visit (Week 52) of Study 248. Subjects will continue to receive aripiprazole IM Depot every month (study months are every 4 weeks which is defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 248.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
  • Subjects who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.
  • The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which is defined as 28 [-2/+10] days) of the last injection in Study 248.
  • Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Subjects able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.
  • Outpatient status.

Exclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, MDD, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
  • Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
  • Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
  • Electroconvulsive therapy within 180 days prior to entry.
  • Any subject who requires or may need any other antipsychotic medications during the course of the study.
  • Aripiprazole IM Depot (including generic formulation) is commercially available in the subject's country.
  • Other protocol specific inclusion/exclusion criteria may apply
  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: NCT01129882

  Show 102 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01129882     History of Changes
Other Study ID Numbers: 31-10-270
Study First Received: May 22, 2010
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014