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Digital Medicine

ABILIFY MYCITE Group for Schizophrenia (DIMES Trial)

Phase 4
Waitlist Available
Led By Hayden Bosworth, PhD
Research Sponsored by Durham VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

DIMES Trial Summary

This study is evaluating whether a digital medicine system (DMS) is more effective than treatment as usual (TAU) for adult patients with schizophrenia, bipolar I disorder, and major depression.

Eligible Conditions
  • Schizophrenia
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Depression

DIMES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aripiprazole refills
Secondary outcome measures
Days in acute care settings
Population Proportion of Days Covered (PDC)

DIMES Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ABILIFY MYCITE GroupExperimental Treatment1 Intervention
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.
Group II: Treatment as Usual (TAU) GroupActive Control1 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.

Find a Location

Who is running the clinical trial?

Durham VA Medical CenterLead Sponsor
37 Previous Clinical Trials
9,228 Total Patients Enrolled
2 Trials studying Schizophrenia
428 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development and Commercialization, Inc.UNKNOWN
Hayden Bosworth, PhDPrincipal InvestigatorDurham VA Medical Center
6 Previous Clinical Trials
952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
2019. "DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03881449.
~8 spots leftby Apr 2025
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