Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.
Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
-
Granada Hills, California, Förenta staterna, 91344
-
-
New York
-
Rochester, New York, Förenta staterna, 14603
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27714
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23230
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Must be able to swallow tablets
- Currently taking a stable daily dose of oral aripiprazole
- Must have capacity to utilize the technology
- Skin in area of patch application must be free of any skin disorders or dermatological problems
Exclusion Criteria:
- Subjects using long acting injectable antipsychotic medications
- Subjects likely to be incapable of using the Digital Medicine System even with assistance
- Subjects who present serious risk of suicide
- History of epilepsy or seizures
- History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker
- Current history of substance use disorder meeting DSM-5 criteria
- Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Aripiprazole + IEM
Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) .
They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.
Tidsram: From baseline upto week 9
|
The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:
The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls |
From baseline upto week 9
|
Samarbetspartners och utredare
Utredare
- Studierektor: Tim Peters-Strickland, M.D., Otsuka Pharmaceutical Development & Commercialization, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Beteendesymtom
- Mentala störningar
- Patologiska processer
- Humörstörningar
- Schizofrenispektrum och andra psykotiska störningar
- Depression
- Depressiv sjukdom
- Schizofreni
- Sjukdom
- Depressiv sjukdom, major
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Antipsykotiska medel
- Lugnande medel
- Psykotropa droger
- Serotoninmedel
- Antidepressiva medel
- Dopaminagonister
- Dopaminmedel
- Serotonin 5-HT1-receptoragonister
- Serotoninreceptoragonister
- Serotonin 5-HT2-receptorantagonister
- Serotoninantagonister
- Dopamin D2-receptorantagonister
- Dopaminantagonister
- Aripiprazol
Andra studie-ID-nummer
- 316-13-215
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .