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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Aripiprazole Once-Monthly; Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	December 2014
Estimated Primary Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Aripiprazole Once-Monthly; Switch to 400 mg aripiprazole once-monthly injection	Drug: Aripiprazole Once-Monthly
Active Comparator: Standard of Care; Continue current SOC oral antipsychotic medication	Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc); Oral antipsychotic medication

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. Quality of Life [ Time Frame: from date of randomization up to 3 months ]
   Schizophrenia Quality of Life Scale (SQLS)
3. Cognition [ Time Frame: from date of randomizatino up to 3 months ]
   Brief Assessment of Cognition in Schizophrenia (BACS)
4. Substance Use [ Time Frame: from date of randomization up to 3 months ]
   Alcohol Use Scale (AUS) and Drug Use Scale (DUS)
5. 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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Contacts

Contact: Elizabeth Bannister	214-648-4603	elizabeth.bannister@utsouthwestern.edu

Locations

United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Matt Byerly, MD

Sponsors and Collaborators

Matt Byerly

Otsuka America Pharmaceutical

Investigators

Principal Investigator:	Matt Byerly, MD	UT Southwestern Medical Center

More Information

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Responsible Party:	Matt Byerly, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT02282085 History of Changes
Other Study ID Numbers:	COL.AOM.2013.004
First Posted:	November 4, 2014
Last Update Posted:	June 8, 2015
Last Verified:	June 2015

Keywords provided by Matt Byerly, University of Texas Southwestern Medical Center:

Medication Non-Adherence; Antipsychotic

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Risperidone; Ziprasidone; Lurasidone Hydrochloride; Antipsychotic Agents; Aripiprazole; Olanzapine; Quetiapine Fumarate; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs	Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists