Bipolar Disorder Trial, Recruiting NCT06373016 Sponsor: Stony Brook University Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT06373016
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with bipolar disorder using a standardised clinical interview based on the DSM-5 diagnostic guidelines
  • People with bipolar disorder whose condition is currently stable and not in an active mood episode, with no hospital admissions in the four weeks before joining
  • People aged between 18 and 45 years (applies to both bipolar disorder patients and healthy comparison participants)
  • People who weigh 350 pounds (approximately 159 kg) or less
  • People whose body diameter when lying flat does not exceed 60 cm (confirm with trial site)
  • People whose HbA1c (a blood sugar level marker) is below 7%
  • People who are able to understand and sign a consent form on their own behalf
  • People who have 20/20 vision, or whose vision can be corrected to 20/20 with contact lenses

Who may not be able to join:

  • People who have any metal implants or devices in their body that are not safe for MRI scans, such as a pacemaker, shrapnel, or joint pins
  • People who experience claustrophobia (fear of enclosed spaces)
  • People with a history of a significant head injury
  • People who have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past three months
  • People who have previously had vagus nerve stimulation or deep brain stimulation treatment
  • People who are considered to be at serious risk of suicide or harming others
  • People with an unstable medical condition affecting the heart, liver, kidneys, lungs, hormonal system, nervous system, or blood
  • People who have a seizure disorder
  • People who have been diagnosed with an alcohol or drug use disorder in the last six months, or who test positive for illicit substances at screening (a positive result for cannabis alone does not automatically exclude someone)
  • Healthy volunteers who are taking any psychiatric or neurological medications, or who have a history of neurological disease
  • People with Type 1 diabetes
  • People who regularly take insulin or other diabetes medications, such as Metformin or GLP-1 receptor agonists
  • People with kidney disease, as identified through medical history or blood tests
  • People with a history of heart attack or stroke
  • People who have difficulty swallowing
  • People who have myxedema (a severe form of thyroid deficiency)
  • People who are currently pregnant (confirmed by urine test at screening and before each MRI visit)
  • People who are currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Lilianne R Mujica-Parodi, Ph.D., SUNY Stony Brook University

Phone: 914-325-0868

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Stony Brook University
Registry
ClinicalTrials.gov
Start date
26 January 2024
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Stabilization of brain networks (general brain functioning); Relative stabilization or destabilization of brain networks in response to metabolic bolus; Prefrontal-limbic circuit regulation; Cortico-striatal circuit regulation; Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov