An interventional study of Transition-FOCUS mHealth Intervention and Check-In in Bipolar Disorder, Major Depression and Schizophrenia, sponsored by Butler Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
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Among 837 studies in Bipolar Disorder with a site in United States — 77 open to participants now, 96 under way, 8 of them phase 3. Bipolar Disorder · United States.
Among the 837 studies in Bipolar Disorder with a site in United States, this one is the 150th largest by planned enrollment of the 704 interventional ones that give a count, is one of 26 that started in 2023, is one of 277 with no phase, reaches primary completion later than 40 of the 94 other live ones, and was the 741st registered.
1,684 studies on the registry are indexed under Bipolar Disorder; 267 are open to participants now.
Browse Bipolar Disorder studies →77 of the 837 studies in Bipolar Disorder with a site in United States are open now. Recruiting first, the newest first:
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 22–70
Massachusetts General Hospital · Sites in United States
Ages 18–65
Massachusetts General Hospital · Sites in United States
Ages 18–65
AbbVie · Sites in United States
Ages 18–65
VA Office of Research and Development · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 205 Bipolar Disorder studies recruiting now, 59 (29%) set no upper age limit and 134 (65%) stop at 75 or younger; 37 take children under 18; 50 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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837 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 56 · Phase 2 119 · Phase 3 129 · Phase 4 155
First in 1979; this study’s year is marked. 26 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Median enrollment 58 across the 704 interventional studies, 107 across the 128 observational. Of the 695 that completed or were terminated, 304 (44%) have results posted.
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148 of 837 have an industry lead sponsor. The 10 most frequent:
Butler Hospital is the lead sponsor of 119 studies on the registry; 14 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Butler Hospital has 5 studies filed under Bipolar Disorder — fewer than ten, so there is no comparison to draw.
37 of the studies in Bipolar Disorder with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07140913Phase 3Bristol-Myers SquibbA Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine | 2027-06-28 |
| NCT05457127University of California, San DiegoObstructive Sleep Apnea Treatment in Serious Mental Illness | 2026-11 |
| NCT03573349Mayo ClinicKetamine Associated ACC GABA and Glutamate Change and Depression Remission: | 2026-12 |
| NCT03349528Sheppard Pratt Health SystemProbiotics to Prevent Relapse After Hospitalization for Bipolar Depression | 2026-12 |
| NCT06226025Leslie SwansonCorrecting Circadian Rhythms to Breakthrough in Bipolar Disorder | 2026-12 |
Add all 37 to your calendar (.ics) → With an account.
Among the 837 studies in Bipolar Disorder with a site in United States, from their registry updates:
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The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants will download the tFOCUS app to their mobile phone. tFOCUS uses EMA to assess variables identified as being salient to treatment engagement and illness self-management. The application delivers algorithm-driven micro interventions to address reported problem(s). Data is transmitted to a clinician "dashboard," which can be used for remote monitoring.
Behavioral: Transition-FOCUS mHealth Intervention
Control participants will receive the currently recommended best practices of post-discharge care, including follow-up appointments, instructions, referrals and a follow-up check in.
Behavioral: Check-In
tFOCUS integrates evidence-based strategies for self-management of severe mental illness (SMI) into a comprehensive mobile assessment and treatment system that is grounded in theoretical SMI models. The application promotes self-management strategies aimed at improving medication adherence to manage biologically driven psychiatric symptoms, increase social support to reduce the negative impact of social withdrawal, improve sleep hygiene to reduce levels of fatigue, and promote strategies for coping with persistent symptoms. tFOCUS application strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience
Also known as: tFOCUS
Check-in includes a discharge and safety plan (with medication instructions, crisis services, etc.), a timely follow-up appointment with a mental health provider, and phone check-ins by case managers immediately following post-discharge for care coordination purposes.
Brief Psychiatric Rating Scale (BPRS)
The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.
Time frame: 24 weeks
Recovery Assessment Scale (RAS)
The RAS is a self-report measure of aspects of mental health recovery, including hope and self-determination. The total score (sum of items) will be used and ranges from 22 to 110 with higher scores indicating higher suicidal thoughts and behaviors.
Time frame: 24 weeks
Plan to share: Yes — Data will be uploaded to the NIMH Data Archive.
Supporting information: Study protocol
Time frame: De-identified data will be available after the project is completed without time limit.
Access criteria: See guidelines of the NIMH Data Archive.
Data sharing details ↗ · nda.nih.gov
Started Feb 2023 (actual). Primary completion is estimated for Jul 2027, 53 months after the start.
Of 354 non-industry interventional studies with no phase under Bipolar Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 53 months is above that.
Counting every sponsor, half of 356 studies reached it within 37 months; a quarter within 23 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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