Bipolar Disorder Trial, Recruiting NCT07221864 Sponsor: Laureate Institute for Brain Research, Inc. Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT07221864
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 aged between 18 and 65 years old
  • People of any gender
  • People with a body weight in the healthy to moderately overweight range (BMI between 18.5 and 38.0) at the initial screening appointment
  • People who are able to understand and follow the study requirements
  • People who are fluent in English
  • People who are able to give their informed consent to participate

For the Bipolar Disorder group specifically:

  • People who have been diagnosed with Bipolar Disorder Type I or Type II (according to standard diagnostic guidelines) and are currently experiencing depression or a mixed mood state, as confirmed by a structured interview
  • People whose depressive symptoms are at least moderate in severity, as measured by standard rating scales (confirm with trial site)

For the Healthy Comparison group specifically:

  • People who have no current or past diagnosed psychiatric condition, as confirmed by a structured interview

Who may not be able to join:

  • People who do not have access to a telephone
  • People with significant ongoing medical conditions, including unstable liver or kidney problems, glaucoma, or serious and unstable heart, lung, digestive, hormonal, neurological, blood, or metabolic conditions — or any other condition the investigator believes could affect safety or study results
  • People who test positive for drugs of abuse or alcohol at screening, including cocaine, opioids, amphetamines, benzodiazepines, and several others listed
  • People who show signs of drug or alcohol intoxication or reported withdrawal at screening or during the study session, or who have used cannabis within 48 hours before the study session
  • People who currently have a psychosis-related diagnosis or a moderate to severe substance use disorder
  • People with moderate to severe traumatic brain injury, other brain or cognitive conditions, or serious or unstable medical conditions that could be affected by taking part in the study
  • People who currently have significant thoughts of suicide, or who have made a suicide attempt in the past 3 months
  • People whose medication dose or prescription has changed in the 6 weeks before enrolling, where that medication could affect brain function (such as anti-anxiety medications, antipsychotics, antidepressants, or mood stabilisers)
  • People taking certain medications that could interfere with the brain imaging used in the study (confirm with trial site for specific medications)
  • People with any physical implants or conditions that make MRI scanning unsafe, as identified by standard MRI screening
  • People who are unwilling or unable to complete the main parts of the study, including the MRI scan (for example, due to severe claustrophobia) or the behavioural assessments
  • People with vision or hearing problems that cannot be corrected

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 28 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

Phone: 918-502-5137

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
Laureate Institute for Brain Research, Inc.
Registry
ClinicalTrials.gov
Start date
30 October 2025
Est. completion
1 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Decoded Emotional State Trajectory; Metastability of brain network states

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: 28 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