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

NCT02282085 | Unknown Phase 4 DMC

• 1 other identifier: COL.AOM.2013.004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Medication Non-Adherence; Antipsychotic

Outcome Measures

Primary Outcomes (1)

• Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response

  PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits.

  from date of randomization up to 3 months

Secondary Outcomes (5)

• Efficacy: PANSS total score overall - symptom severity

  from date of randomization up to 3 months

• Quality of Life

  from date of randomization up to 3 months

• Cognition

  from date of randomizatino up to 3 months

• Substance Use

  from date of randomization up to 3 months

• 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)

  from date of randomization up to 3 months

Study Arms (2)

Aripiprazole Once-Monthly

EXPERIMENTAL

Switch to 400 mg aripiprazole once-monthly injection

Drug: Aripiprazole Once-Monthly

Standard of Care

ACTIVE COMPARATOR

Continue current SOC oral antipsychotic medication

Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)

Interventions

Aripiprazole Once-Monthly DRUG

Aripiprazole Once-Monthly

Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc) DRUG

Oral antipsychotic medication

Standard of Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Matt Byerly: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Medication Adherence

Interventions

Antipsychotic Agents; Risperidone; Lurasidone Hydrochloride; Quetiapine Fumarate; Olanzapine; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Heterocyclic Compounds, 3-Ring; Benzodiazepines; Benzazepines

Study Officials

• Matt Byerly, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Bannister

CONTACT

214-648-4603; elizabeth.bannister@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: November 4, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)