Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

2026 data Public-data reference. official source

Bipolar Depression

Open-data reference.

30 US clinical trials · 8 currently recruiting

Active & Recent Trials

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
Early Phase 1 3
Phase 2 2
Phase 3 9
Phase 4 3

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

Reading the Bipolar Depression Trial Landscape

ClinicalTrials.gov lists 30 US studies indexed under Bipolar Depression, and 8 of those are currently open to recruitment — roughly 27% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Bipolar Depression shows 12 late-stage studies (Phase 3 and Phase 4 combined) alongside 5 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Bipolar Depression is led by Intra-Cellular Therapies with 4 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 30 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Bipolar Depression?

PlainTrial tracks 30 US clinical trials for Bipolar Depression, of which 8 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Bipolar Depression?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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