Diseases / Bipolar Disorder
Bipolar Disorder
DiseaseBipolar disorder is a mental illness characterized by episodes of mood elevation (mania or hypomania) and depression that can significantly affect functioning.
- Trials
- 1651
- Recruiting
- 161
- Completed
- 1041
- With results
- 354
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 2 | 4 | 2 | 2 | — | 2 | 12 |
| Phase 1 | 3 | — | — | 1 | 38 | 9 | — | 1 | 2 | 54 |
| Phase 1/2 | 2 | — | — | — | 13 | — | 2 | — | 4 | 21 |
| Phase 2 | 12 | 1 | — | 3 | 87 | 18 | 8 | — | 4 | 133 |
| Phase 2/3 | 1 | — | — | 1 | 14 | 3 | 1 | — | 2 | 22 |
| Phase 3 | 10 | 1 | 1 | 1 | 162 | 18 | 5 | 1 | 8 | 207 |
| Phase 4 | 10 | 3 | — | 1 | 164 | 23 | 12 | 1 | 18 | 232 |
| Not applicable | 83 | 21 | 5 | 18 | 361 | 29 | 11 | 3 | 97 | 628 |
| Unknown | 40 | 11 | 6 | 9 | 198 | 13 | 7 | 1 | 57 | 342 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Bipolar Disorder | 12 | 54 | 21 | 133 | 22 | 207 | 232 | 628 | 342 | 1651 |
| Schizophrenia | 1 | 14 | 1 | 12 | 1 | 15 | 27 | 186 | 81 | 338 |
| Depression | 3 | 7 | 5 | 42 | 7 | 24 | 39 | 106 | 57 | 290 |
| Depressive Disorder, Major | 5 | 6 | 3 | 13 | 3 | 11 | 20 | 108 | 76 | 245 |
| Psychotic Disorders | 2 | 7 | — | 18 | 2 | 14 | 26 | 110 | 36 | 215 |
| Mania | — | 2 | 1 | 17 | 1 | 34 | 27 | 17 | 15 | 114 |
| Mood Disorders | — | 1 | 1 | 19 | — | 6 | 6 | 36 | 37 | 106 |
| Mental Disorders | — | — | — | 9 | — | 3 | 2 | 64 | 22 | 100 |
| Depressive Disorder | — | 4 | — | 9 | 2 | 3 | 7 | 32 | 24 | 81 |
| Anxiety Disorders | 1 | 1 | 3 | 3 | — | 2 | 5 | 27 | 17 | 59 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Massachusetts General Hospital | 63 | 2 |
| 2 | AstraZeneca | 47 | 16 |
| 3 | National Institute of Mental Health (NIMH) | 41 | 2 |
| 4 | Mclean Hospital | 33 | 1 |
| 5 | Stanford University | 23 | 1 |
| 6 | University of Pittsburgh | 22 | 4 |
| 7 | University of Texas Southwestern Medical Center | 22 | 3 |
| 8 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 21 | 16 |
| 9 | University Hospitals Cleveland Medical Center | 21 | 9 |
| 10 | VA Office of Research and Development | 20 | 1 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Quetiapine Fumarate | 76 |
| 2 | Lithium | 64 |
| 3 | Valproic Acid | 56 |
| 4 | Lamotrigine | 49 |
| 5 | Olanzapine | 47 |
| 6 | Aripiprazole | 43 |
| 7 | Risperidone | 40 |
| 8 | Lithium Carbonate | 37 |
| 9 | Therapeutics | 35 |
| 10 | ziprasidone | 35 |
Evidence
- Results reported
- 34%354 of 1041 completed
- Published
- 11.9%124 of 1041 completed
- Primary endpoint met
- 37.8%146 of 386 analyses
- Median months to report
- 17
Documents disclosed
Trial profile
- Median enrollment
- 75
- Median duration
- 34months
- Countries
- 75
- Study sites
- 5976
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 8
- Phase 1
- 30
- Phase 1/2
- 49
- Phase 2
- 51
- Phase 2/3
- 74
- Phase 3
- 158
- Phase 4
- 50
- Not applicable
- 64
- Unknown
- 150
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 90 |
| 2 | Cleveland | United States | 80 |
| 3 | Boston | United States | 79 |
| 4 | Cincinnati | United States | 77 |
| 5 | Houston | United States | 68 |
| 6 | San Diego | United States | 64 |
| 7 | Dallas | United States | 62 |
| 8 | Chicago | United States | 59 |
| 9 | Philadelphia | United States | 58 |
| 10 | Toronto | Canada | 58 |
Terminations
- Terminated
- 115
- Withdrawn
- 48
- Suspended
- 7
- Stopped for recruitment
- 2.5%42 of 1651 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04031469 Suspended | Suspended | Administrative | 2030-12-10 |
| NCT04211428 Withdrawn | Withdrawn | Company shifted focus | 2030-07-31 |
| NCT05340686 Suspended | Suspended | Difficulties recruiting | 2029-04-20 |
| NCT04640636 Suspended | Suspended | The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023. | 2028-03-31 |
| NCT06384521 Withdrawn | Withdrawn | No funding obtained | 2027-09-30 |
| NCT05060549 Withdrawn | Withdrawn | Funding decision | 2027-05-01 |
| NCT06129500 Suspended | Suspended | Paused due to change in staffing arrangements | 2027-01-24 |
| NCT06733558 Withdrawn | Withdrawn | NIGMS, the funding agency, does not consider this study a clinical trial and they asked to remove from the system. | 2026-07-31 |
| NCT02719392 Withdrawn | Withdrawn | Study did not receive funding and was never carried out. | 2026-07-20 |
| NCT05974527 Withdrawn | Withdrawn | Study did not start - due to funding issues prior to IRB approval | 2026-06-30 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: