An interventional study of BA and SHE in Bipolar Disorder (BD), sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
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 546th largest by enrollment of the 704 interventional ones that give a count, is one of 26 that started in 2018, is one of 277 with no phase, and was the 834th registered.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 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 203 Bipolar Disorder studies recruiting now, 59 (29%) set no upper age limit and 132 (65%) stop at 75 or younger; 37 take children under 18; 49 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below 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.
This tab as a report to print or save as PDF → With an account.
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 |
Among the 837 studies in Bipolar Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness. The investigators will also compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels. The investigators will also compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase.
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
There are two phases for participants: intervention phase (3 months), which consists of intensive contact, and the follow-up phase (3 months). BA will consist of one, 45-minute session about public health recommendations, and strategies for getting started. SHE will be a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions for home-based exercise with the goal of gradually achieving the public health recommendation of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will address barriers to physical activity that are particularly pronounced in depression -i.e., anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving skills. During the follow-up phase, groups who received SHE during the intervention phase will receive brief, monthly phone check-ins from an exercise specialist.
Primary Aims:
Inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brief advice to exercise. This serves as a control condition.
Behavioral: BA
Brief advice to exercise + supervised \& home-based exercise + health education
Behavioral: BA · Behavioral: SHE · Behavioral: HE
Brief advice to exercise + supervised \& home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
Behavioral: BA · Behavioral: SHE · Behavioral: CBEX
The BA intervention will be conducted in one 45-minute session in the week after randomization. Participants will meet with the exercise physiologist and have a discussion about: public health guidelines for physical activity (i.e., gradual increase to 150 minutes of MVPA per week), physical and mental health benefits of physical activity, components of typical workout (including warm-up, aerobic zone, cool-down, and knowing when to stop), and how to determine exercise intensity (e.g., rate of perceived exertion (RPE) scale, obtaining radial and carotid pulse), the benefits of maintaining a structured schedule of consistent daily routines and a regular sleep schedule to manage depression and mania.
Participants assigned to SHE will attend individual aerobic exercise (AE) sessions supervised by an exercise physiologist once a week at the Butler Hospital Fitness Facility. Exercise at the Butler Hospital Fitness Facility will last \~1 hour, and includes: review of self-monitoring logs (5 minutes), warm-up (5-10 mins), AE (beginning at 20 minutes per session with weekly gradual increases based on heart rate monitoring by the exercise physiologist, with the target being the moderate-intensity range of 64-76% of age-predicted maximal heart rate (28) for each participant), cool-down (5-10 minutes), stretching (5 minutes), and exercise plans for the next week (5 minutes). Participants will choose from several types of exercise equipment, including treadmills, recumbent bicycles, and elliptical machines.
Health education sessions will serve as a contact control for CBEX. Participants will attend individual sessions. After the initial BA session (week 1), sessions will include HE information such as: nutrition; caffeine; colds, germs, and flu; preventing cancer; diabetes; heart health; sleep; complementary and alternative medicine; caffeine; and being a smart patient
Participants in the CBEX condition will participate in a 30-minute individual counseling session focused on teaching cognitive-behavioral skills to help with increasing motivation and adherence to exercise. CBEX targets: 1) anhedonia, amotivation, increased fatigue, and other individual-level barriers associated with major depression; 2) other individual-level determinants of behavior change described by the Health Belief Model and self-determination theory; and 3) social environment and physical environment factors associated with exercise (through social skills coaching and problem-solving training). Each session will begin with a review of personal barriers and facilitators to exercise, and the therapist will assist the patient with using skills learned in CBEX to manage barriers. Sessions will emphasize making personal choices consistent with goals and values, and participants will have menus of options whenever possible. Participants receive a workbook to use for this intervention
To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)
CSQ scores range from 8 to 32. Higher scores indicate a greater degree of satisfaction.
Time frame: at 3 months
To measure the acceptability, feasibility, and safety of the program via adherence to weekly SHE and HE or CBEX sessions
Participants attended between 0 and 11 SHE and HE or CBEX sessions. Higher scores indicate higher adherence.
Time frame: from baseline to 3 months
To measure the acceptability, feasibility, and safety of the program via completion of 3 month and 6 month interviews
Time frame: at 3 months, 6 months
To compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase via International Physical Activity Questionnaire (IPAQ)
The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.
Time frame: from baseline to 3 months
To compare preliminary long-term effect of the 3 arms on minutes of MVPA at 6-month follow-up via International Physical Activity Questionnaire (IPAQ)
The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.
Time frame: from 3 months to 6 months
Ran from Jan 2018 to primary completion in Apr 2020, 26 months.
Of 352 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 26 months is below that.
Counting every sponsor, half of 354 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.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.