Aripiprazole, Abilify Maintena Collaborative Clinical Protocol
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|ClinicalTrials.gov Identifier: NCT02717130|
Recruitment Status : Unknown
Verified March 2016 by Florida Atlantic University.
Recruitment status was: Recruiting
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole||Not Applicable|
Hide Detailed Description
This is an open-label, multi-center, longitudinal, within-subject comparison study of the effects of aripiprazole once monthly on 30-, 90-, and 180-day psychiatric re-hospitalization rates following hospital discharge in subjects with schizophrenia compared with prior psychiatric hospitalization rates while on oral antipsychotics.
Prospective subjects will undergo screening for eligibility for entry into the study while hospitalized for symptoms due to schizophrenia.
Prospective subjects will be hospitalized for the necessary length of time as determined by the assigned treatment provider as clinically indicated, per the current standard of care. To be eligible, the anticipated duration of hospitalization should be long enough to accommodate the screening procedures, the 3-day Oral Tolerability Phase (if applicable), and initiation of treatment with aripiprazole once monthly.
During the Screening Period, subjects can be treated with any oral antipsychotic medication of the clinician's choice, with the exception of clozapine and olanzapine. However, oral olanzapine is permitted during the Screening Period only for subjects who are eligible for Phase A. Following the Screening Period, subjects who have no history of aripiprazole use will be entered into Phase A, the Oral Tolerability Phase. Subjects from Phase A that demonstrate tolerability to aripiprazole will then be entered into Phase B (i.e., the Treatment Phase). Subjects who already have a history of tolerating at least three consecutive oral doses of aripiprazole will be entered directly into Phase B. All eligible subjects will eventually enter Phase B.
Subjects who meet the inclusion and exclusion criteria and have no history of oral aripiprazole use will enter Phase A after the Screening Period while still hospitalized. Subjects in Phase A will be administered oral aripiprazole, as indicated in the product labeling, to determine tolerability. Dosage will be based on symptoms and the judgment of the investigator. The dose of oral aripiprazole may be titrated as needed. Prior antipsychotic medications will be tapered off and discontinued during the Screening Period and Phase A as clinically appropriate.
During Phase A, tolerability to oral aripiprazole will be evaluated daily for a minimum of 3 days using safety and tolerability measures (i.e., AIMS, BARS, and SAS) in conjunction with clinical judgment. If the subject shows tolerability to the oral aripiprazole, the Phase B baseline/Day 1 should occur with the first aripiprazole once monthly injection given immediately after the Phase B baseline/Day1 assessments. If a subject is unable to tolerate oral aripiprazole during the tolerability assessment in Phase A, he or she will be withdrawn from the study.
During Phase B, the subject will receive the first aripiprazole once monthly intramuscular (IM) injection, in conjunction with the first of 14 doses of concomitant oral aripiprazole, as indicated in the product labeling, after the baseline data are collected.
All subjects must attend scheduled visits at the Baseline Visit and Weeks 2, 4, 8, 12, 16, 20, and 24, totaling 180 days. Aripiprazole once monthly injections will occur at the Baseline Visit and every 28 ( -2, +5) days at Weeks 4, 8, 12, 16, 20, and 24, totaling seven injections. After the initial injection of 400 mg, the monthly dosage can be decreased to 300 mg, based on the clinical judgment of the investigator. All aripiprazole once monthly injections will be administered based on the investigator's judgment and the prescribing information.
For subjects who are psychiatrically stabilized and discharged prior to the completion of the required 14-day course of oral aripiprazole, a pre-discharge assignment will be given to a community support worker (CSW). The CSW will maintain regular contact with the subject until the first outpatient visit in Phase B (Week 2), when oral aripiprazole will be discontinued. Regular contact is defined as no less than weekly, but can be more frequent depending on the clinical judgment of the CSW and outpatient treatment team. Following the Week 2 Visit, subjects will have contact with their assigned CSW based on routine clinical care. Contact with the CSW can be in person or by telephone, as clinically appropriate.
Note: All long-acting antipsychotics are excluded from use during the study; however, aripiprazole once monthly is allowed
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||177 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aripiprazole, Abilify Maintena Collaborative Clinical Protocol|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Aripiprazole (Abilify Maintena)
Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.
- Psychiatric re-hospitalization rates will be assessed using hospital admission records [ Time Frame: 30 days ]
- Unscheduled psychiatric emergency department visits will be assessed using hospital records [ Time Frame: 30 days ]
- Psychiatric emergency department visits plus hospitalizations will be assessed using hospital records [ Time Frame: 30 days ]
- Total psychiatric hospitalization days will be assessed using hospital admission records [ Time Frame: 180 days ]
- The effects of aripiprazole once monthly will be assessed using the Clinical Global Impression-Severity (CGI-S) score. [ Time Frame: 30 days ]
- The effects of aripiprazole once monthly will be assessed using the Clinical Global Impression-Improvement (CGI-I) score. [ Time Frame: 30 days ]
- Evaluate changes from baseline for weight (kg) [ Time Frame: 180 days ]
- Evaluate changes from baseline for body mass index (BMI) (kg/m^2) [ Time Frame: 180 days ]
- Evaluate changes from baseline for fasting glucose concentrations [ Time Frame: 180 days ]
- Evaluate changes from baseline for HbA1c concentrations [ Time Frame: 180 days ]
- Evaluate changes from baseline for fasting triglycerides [ Time Frame: 180 days ]
- Evaluate changes from baseline for fasting total cholesterol [ Time Frame: 180 days ]
- Evaluate changes from baseline for fasting high-density lipoprotein (HDL) cholesterol [ Time Frame: 180 days ]
- Evaluate changes from baseline for fasting low-density lipoprotein (LDL) cholesterol [ Time Frame: 180 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717130
|Contact: Mary Lou Ricciofirstname.lastname@example.org|
|Contact: Carrie Perezemail@example.com|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65211|
|Contact: John Lauriello, MD 573-882-8913 firstname.lastname@example.org|
|Contact: Christopher Sinkler 573-884-1073 email@example.com|
|University of Missouri||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Roger Sommi, PharmD 816-512-7475 SommiR@umkc.edu|
|Burrell Behavioral Health||Not yet recruiting|
|Springfield, Missouri, United States, 65804|
|Contact: Paul Thomlinson, PhD 417-761-5015 Paul.Thomlinson@burrellcenter.com|
|St. Louis, Missouri, United States, 63110|
|Contact: Ginger Nicol, MD 314-362-2461 firstname.lastname@example.org|
|Contact: Julie Schweiger, CCRC 314-362-3153 email@example.com|
|Principal Investigator:||John Newcomer, MD||Florida Atlantic University|
|Principal Investigator:||Ginger Nicol, MD||Washington University School of Medicine|