DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

NCT03881449 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 02188
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

This is a 12 month, pragmatic trial designed to assess the differences in a digital medicine system (DMS)- ABILIFY MYCITE (Aripiprazole tablets with sensor)- measuring adherence versus treatment as usual (TAU) for adult patients with schizophrenia, bipolar I disorder, and major depression. Outcomes of interest will be adherence as measured by refill rates and all-cause and psychiatric health care use. Each patient will be in the study for a duration of 12 months. All treatment medication decisions will be made by the healthcare professionals (HCPs) and not by protocol. Psychiatrist(s), nurse(s) and/or team manager(s) who will be responsible for subjects' care, will be considered as HCPs in this trial.

Conditions

Schizophrenia; Major Depressive Disorder; Bi-Polar Disorder; Schizo Affective Disorder

Keywords

digital medicine

Outcome Measures

Primary Outcomes (1)

• Aripiprazole refills

  Aripiprazole refill as operationalized as a continuous measure of the number of days covered over the baseline to 6 month period

  6 months

Secondary Outcomes (2)

• Population Proportion of Days Covered (PDC)

  12 months

• Days in acute care settings

  12 months

Study Arms (2)

ABILIFY MYCITE Group

EXPERIMENTAL

If patients are assigned to the ABILIFY MYCITE treatment group, the patients and physician will initiate the system at the baseline visit, and continue to use the system for 3 months. At any time after the first 3 months, a patient and his or her doctor will have the opportunity to either discontinue or continue using ABILIFY MYCITE for the remainder of the trial (9 additional months; 12 months total) as long as clinically appropriate with the goal of measuring adherence to improve clinical decision-making and care. Both ABILIFY MYCITE and TAU participants will complete a battery of questions related to quality of life, patient usability/satisfaction, etc. at baseline, 3, 6 and 12 months.

Combination Product: ABILIFY MYCITE

Treatment as Usual (TAU) Group

NO INTERVENTION

TAU patients will continue receiving care as recommended by their physician which will include the use of Aripiprazole according to the approved labels. Both ABILIFY MYCITE and TAU participants will complete a battery of questions related to quality of life, patient usability/satisfaction, etc. at baseline, 3, 6 and 12 months.

Interventions

ABILIFY MYCITE COMBINATION_PRODUCT

Initiation of ABILIFY MYCITE will commence immediately, with subjects wearing the patch and using the smartphone app for a total of 3 months from baseline visit to the 3 month visit. Following the initial 90-days, the physician and patient may determine to use ABILIFY MYCITE anytime during the following 9 months. Following this period (up to 12 months), the subjects will not use ABILIFY MYCITE and return to standard care. A safety follow-up phone call will occur at 2 weeks after the 12 month/early termination (ET) visit. In addition, individuals in the ABILIFY MYCITE arm will evaluate satisfaction with the use of ABILIFY MYCITE.

ABILIFY MYCITE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years of age or older.
• Patients with a primary diagnosis of schizophrenia (including schizoaffective disorder), bipolar I disorder, or major depressive disorder based on the Diagnostic Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria.
• Patients have an active prescription for oral Aripiprazole.
• Patients may have general medical conditions that are deemed safe for the patient to enter an interventional trial per investigator judgment.
• Patients deemed fit for participation in the study by verbal or written confirmation from their mental health provider

You may not qualify if:

• Patients with a current neurocognitive disorder (i.e. dementia), intellectual disorder, or any other diagnosis that could impact the patient's ability to participate in the trial.
• Any patient who, in the opinion of the patient's mental health provider, study physician or investigator, is unfit to participate in the trial.
• Any patient who has participated in an investigational drug trial 30 days prior to trial enrollment.
• Females who are breastfeeding, and/or who have a positive pregnancy test prior to trial enrollment, or females who are planning to become pregnant during the trial. No clinical trials have been conducted on the use of ABILIFY MYCITE during pregnancy or breastfeeding.
• Patients who do not have skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems (e.g., dermatosis or dermatitis, open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, or irritations).
• Patients who are unwilling to refrain from the use of topical products on the skin patch sites.
• Has 2 or more errors on the brief, 6-item cognitive screener administered at baseline.
• \<20% Proportion of Days Covered (PDC) Aripiprazole over the last 6 months prior to enrollment. This is to ensure that all individuals enrolled will have at least filled their Aripiprazole prescription.

Sponsors & Collaborators

• Durham VA Medical Center: lead
• Otsuka Pharmaceutical Development and Commercialization, Inc.: collaborator

Study Sites (2)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gonzales S, Okusaga OO, Reuteman-Fowler JC, Oakes MM, Brown JN, Moore S, Lewinski AA, Rodriguez C, Moncayo N, Smith VA, Malone S, List J, Cho RY, Jeffreys AS, Bosworth HB. Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study. JMIR Form Res. 2022 Dec 22;6(12):e34893. doi: 10.2196/34893.

  PMID: 36548028 DERIVED

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Officials

• Hayden Bosworth, PhD

  Durham VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is an open-label 2-site (Durham and Houston Veterans Affairs (VA) Health Care Systems), provider randomized, prospective 2-arm (intervention vs. TAU) pragmatic trial. We will enroll 300 adult patients with schizophrenia, bipolar I disorder, or major depressive disorder currently being treated with oral Aripiprazole from either the Durham, North Carolina or Houston, Texas Veterans Affairs (VA) Health Care System.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 19, 2019
• Study Start: April 4, 2019
• Primary Completion: January 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)