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Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282085
Recruitment Status : Unknown
Verified June 2015 by Matt Byerly, University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : November 4, 2014
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Matt Byerly, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE September 30, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response [ Time Frame: from date of randomization up to 3 months ]
PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Efficacy: PANSS total score overall - symptom severity [ Time Frame: from date of randomization up to 3 months ]
    PANSS total score - continuous, from the three monthly visits
  • Quality of Life [ Time Frame: from date of randomization up to 3 months ]
    Schizophrenia Quality of Life Scale (SQLS)
  • Cognition [ Time Frame: from date of randomizatino up to 3 months ]
    Brief Assessment of Cognition in Schizophrenia (BACS)
  • Substance Use [ Time Frame: from date of randomization up to 3 months ]
    Alcohol Use Scale (AUS) and Drug Use Scale (DUS)
  • Safety assessed by Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: from date of randomization up to 3 months ]
    Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia
Official Title  ICMJE A Randomized, Multi-site, Parallel-group, Rater-blind Study Comparing Response With Aripiprazole Once Monthly and Standard of Care Oral Antipsychotics in Non-adherent Outpatients With Schizophrenia Identified Using the Brief Adherence Rating Scale
Brief Summary

This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes.

It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole once-monthly will be more likely to respond and have lower symptom severity over 3 months of treatment than those receiving standard of care oral antipsychotics.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Aripiprazole Once-Monthly
  • Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)
    Oral antipsychotic medication
Study Arms  ICMJE
  • Experimental: Aripiprazole Once-Monthly
    Switch to 400 mg aripiprazole once-monthly injection
    Intervention: Drug: Aripiprazole Once-Monthly
  • Active Comparator: Standard of Care
    Continue current SOC oral antipsychotic medication
    Intervention: Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
  • Are 18 to 60 years of age, inclusive, at the time of informed consent
  • Has a current diagnosis of schizophrenia, as defined by DSM-V criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., health care provider, family member, or medical records).
  • Have been prescribed a single oral antipsychotic medication for at least 3 months prior to screening.
  • Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, intramuscular (IM) once monthly injection, and discontinuation of prohibited concomitant medications, read and understand the written word in order to complete subject-reported outcomes measures, and be reliably rated on assessment scales.
  • Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to practice double barrier forms of birth control from study screening through 30 days (for females) and 90 days (for males) from the last dose of study drug for SOC oral antipsychotics and 150 days for females and 180 days for males for aripiprazole once monthly. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control once monthly injections, condom, or sponge with spermicide.

Exclusion Criteria:

  • Has a current DSM-V diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
  • Has had a psychiatric hospitalization within the 30 days prior to screening.
  • Has received a depot antipsychotic within the 6 months prior to screening.
  • Is considered resistant or refractory to antipsychotic treatment by history (failed two prior antipsychotic medication studies) or response only to clozapine.
  • Is taking two or more antipsychotics.
  • Has a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's discretion.
  • Has a history of seizures or any other medical condition that would expose the subject to undue risk or interfere with study assessments.
  • Is involuntarily incarcerated or has been incarcerated in the past 6 months for any reason.
  • Has undergone electroconvulsive therapy in the 2 years prior to enrollment in the study.
  • Has used an investigational agent or has participated in a clinical study with aripiprazole once monthly or any other antipsychotic once monthly preparation within 30 days of screening.
  • Has any medical condition that might preclude safe completion of the study (e.g., agranulocytosis, severe and unstable heart disease, AIDS, end-stage renal disease).
  • Is taking a CYP3A4 inducer (e.g., carbamazepine).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282085
Other Study ID Numbers  ICMJE COL.AOM.2013.004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matt Byerly, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE Matt Byerly
Collaborators  ICMJE Otsuka America Pharmaceutical
Investigators  ICMJE
Principal Investigator: Matt Byerly, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP