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ClinicalTrials.gov 8 recruiting now later-stage tilt

Bipolar Depression: later-stage trial registry

8 of 30 indexed Bipolar Depression trials are currently recruiting, with more weight in Phase 3-4.

Corpus placement: #519 of 28,707 conditions by registered trial count.

30 US clinical trials · 8 currently recruiting · #519 of 28,707 conditions by registered trial count

Bipolar Depression: 30 US clinical trials tracked, 8 recruiting.

Bipolar Depression is the subject of 30 registered US clinical trials on ClinicalTrials.gov, 8 of them currently open to new participants. 12 are in Phase 3-4 (later-stage) and 5 in Phase 1-2 (earlier-stage). The most active sponsor is Intra-Cellular Therapies, running 4 of these trials.

Enrollment posture brief

Registry condition bipolar-depression

OPEN 8 | RECR 27% | LATE 12 | EARLY 5 | RANK #519 | SPON 4

Nearest open-share peer: Age-related Macular Degeneration (27% recruiting · 75 trials)

AML60%Acute Myeloid Leukemia40%Bipolar Depression (this)27%Anatomic Stage IA Breast Can26.7%Adult Acute Myeloid Leukemia0%
Open-enrollment share among volume-matched conditions near Bipolar Depression

Bipolar Depression lists 8 open slots (27% of 30 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Bipolar Depression on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Bipolar Depression is recruiting below its size-band peers.

    8 of 30 indexed trials (26.7%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. Sponsorship of Bipolar Depression trials is spread across many organizations.

    Intra-Cellular Therapies accounts for 4 of 30 trials (13.3%). 19 distinct sponsors appear on at least one study for this condition label.

  3. Typical Bipolar Depression enrolment sits around 80 participants.

    Median target enrolment is 80 among the 30 trials that report a genuine target (sentinel values excluded). 16 of those (53.3%) plan for fewer than 100 participants.

  4. Bipolar Depression research is mostly interventional.

    26 interventional and 4 observational studies make up this index (86.7% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 13Phase 22Phase 39Phase 43

Open and recent trials

30 total, page 1 of 1

RECRUITING 1,000 participants

University of Iowa Interventional Psychiatry Service Patient Registry

Mark Niciu

NCT04480918

RECRUITING Phase 3 400 participants

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Xenon Pharmaceuticals

NCT07172516

RECRUITING Phase 3 384 participants

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Intra-Cellular Therapies

NCT06372964

RECRUITING Phase 4 120 participants

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Mayo Clinic

NCT07266545

RECRUITING NA 30 participants

Ketogenic Intervention for Bipolar Depression

Mayo Clinic

NCT07121894

RECRUITING Early Phase 1 20 participants

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Massachusetts General Hospital

NCT03748446

RECRUITING Phase 1 20 participants

Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression

Laureate Institute for Brain Research

NCT06088732

RECRUITING NA 10 participants

Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

Wayne Goodman MD

NCT06599099

ACTIVE NOT RECRUITING 120 participants

Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

Brigham and Women's Hospital

NCT03336918

ACTIVE NOT RECRUITING NA 40 participants

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Mclean Hospital

NCT03484494

ACTIVE NOT RECRUITING NA 20 participants

Focused Ultrasound Amygdala Neuromodulation

University of Texas at Austin

NCT05228964

ACTIVE NOT RECRUITING Early Phase 1 18 participants

Ketamine Associated ACC GABA and Glutamate Change and Depression Remission:

Mayo Clinic

NCT03573349

COMPLETED Phase 3 702 participants

Pediatric Open-Label Extension Study

Sumitomo Pharma America

NCT01914393

COMPLETED Phase 3 676 participants

Seroquel in Bipolar Depression Versus SSRI

AstraZeneca

NCT00119652

COMPLETED Phase 3 554 participants

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Intra-Cellular Therapies

NCT02600494

COMPLETED Phase 3 529 participants

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Intra-Cellular Therapies

NCT02600507

COMPLETED Phase 3 381 participants

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Intra-Cellular Therapies

NCT03249376

COMPLETED Phase 3 356 participants

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Sumitomo Pharma America

NCT01284517

COMPLETED Phase 3 348 participants

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Sumitomo Pharma America

NCT00868452

COMPLETED NA 107 participants

Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Mclean Hospital

NCT00578383

COMPLETED 102 participants

Mechanism of Action of Electroconvulsive Therapy

Massachusetts General Hospital

NCT04059952

COMPLETED Phase 2 80 participants

Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression

Repligen Corporation

NCT00322764

COMPLETED NA 62 participants

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

University of Utah

NCT01805440

COMPLETED 60 participants

Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

Massachusetts General Hospital

NCT01639482

COMPLETED NA 33 participants

Vitamin D Supplementation for Bipolar Depression

University of Massachusetts, Worcester

NCT01884844

COMPLETED NA 23 participants

A Trial of SAMe for Treatment-Resistant Bipolar Depression

Mclean Hospital

NCT00762268

COMPLETED NA 20 participants

Biosignatures of Latuda for Bipolar Depression

New York State Psychiatric Institute

NCT02239094

COMPLETED Phase 2 20 participants

FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

Brian Barnett

NCT06620042

COMPLETED Phase 4 20 participants

Minocycline for Bipolar Depression

Icahn School of Medicine at Mount Sinai

NCT01514422

COMPLETED Phase 4 10 participants

Aripiprazole Treatment of Bipolar Depression

Indiana University School of Medicine

NCT00198198

Phase Distribution

PhaseTrial count
Phase 1 3
Phase 2 2
Phase 3 9
Phase 4 3

Named interventions

Most-linked intervention names on Bipolar Depression records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Placebo Drug
9 trials
Ketamine Drug
3 trials
Uridine Drug
2 trials
Lumateperone Drug
2 trials
SAMe Drug
1 trials
Vitamin D3, Cholecalciferol Drug
1 trials
Placebo + (lithium or divalproex) Drug
1 trials
lurasidone + (lithium or divalproex) Drug
1 trials

US sites by state

Facility locations filed on Bipolar Depression trials. A trial with sites in several states counts in each.

California 10 trials
Massachusetts 9 trials
Florida 9 trials
New York 8 trials
Georgia 7 trials
Arkansas 6 trials
Texas 5 trials
Missouri 5 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

What to do with this Bipolar Depression page

30 registered trials, 8 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Bipolar Depression condition card totals 30 registered trials; most-linked intervention Placebo; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.