CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Aripiprazole + IEM (Ingestible Event Marker)drug
Likely dose
Aripiprazole 2–30 mg orally once daily (with ingestible event marker)AI-extracted
Key inclusion· 5
  • ✓Primary diagnosis of Schizophrenia, Major Depressive Disorder, or Bipolar 1 Disorder per DSM-5
  • ✓Currently taking a stable daily dose of oral aripiprazole
  • ✓Able to swallow tablets
  • ✓Capacity to utilize the digital medicine technology
Key exclusion· 7
  • ✕Currently using long-acting injectable antipsychotics
  • ✕Unlikely to be able to use the Digital Medicine System even with assistance
  • ✕Serious risk of suicide
  • ✕History of epilepsy or seizures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02722967
NCT02722967Phase 2Completed
CompareCT.gov

A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripiprazole

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Mar 30, 2016·Updated May 23, 2018

In Brief

A Phase 2 clinical trial evaluating Aripiprazole + IEM (Ingestible Event Marker) for Schizophrenia and 2 related conditions. Completed, enrolled 49 participants across 4 sites.

Detailed Summary

This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Major Depressive Disorder, Bipolar I Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartMar 1, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.3 years ago

Interventions

Aripiprazole + IEM (Ingestible Event Marker)drug

Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.