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

Status unconfirmed · Phase 4

Conditions studied: Schizophrenia, Major Depressive Disorder, Bi-Polar Disorder, Schizo Affective Disorder

In brief

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.

Key facts

Study ID

NCT03881449

Run by

Durham VA Medical Center

People needed

46

Starts

2019-04-04

Expected to finish

2021-11-01

Last updated by the study team

2020-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Durham VA Medical Center — Durham, North Carolina, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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