Bipolar Disorder Trial, Recruiting NCT06221852 Sponsor: Mclean Hospital Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT06221852
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:

  • You are between 18 and 45 years old.
  • You are able and willing to follow the specific diets required by the study.
  • You have been diagnosed with bipolar I disorder or schizoaffective disorder, and your illness began within the last 7 years.
  • Your mental health condition is currently stable, and your psychiatric medications have not changed in the past 2 weeks before screening.
  • You are not expected to need any new psychiatric medications during the 12 weeks of the study.

Who may not be able to join:

  • You are unable to give written consent to participate in the study.
  • You are unable to have an MRI scan for any reason, including fear of enclosed spaces (claustrophobia).
  • You have an unstable or serious ongoing physical health condition, such as heart, liver, kidney, lung, hormone, nervous system, or blood-related disease.
  • You currently have a diagnosis of substance use disorder (such as alcohol or drug dependency).
  • You are currently pregnant, breastfeeding, or able to become pregnant and are not using an accepted form of contraception.
  • You weigh more than 350 lbs or have a Body Mass Index (BMI) below 20 (confirm with trial site if unsure of your BMI).
  • You score above 15 on a standard scale used to measure symptoms of mania (confirm with trial site).
  • You have a history of a significant head injury.
  • You currently have a cancer diagnosis.
  • You have been diagnosed with type 1 or type 2 diabetes.
  • You have previously had gastric bypass surgery or any other type of weight loss surgery.
  • You are currently being treated with a medication called Propofol.
  • You have a genetic condition called familial hypercholesterolemia, which causes very high cholesterol levels.

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

Principal Investigator: Virginie-Anne Chouinard, MD, Mclean Hospital

Phone: 617-855-3988

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
Mclean Hospital
Registry
ClinicalTrials.gov
Start date
12 March 2024
Est. completion
30 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH); Change in brain creatine kinase forward reaction rate (kf); Change in insulin resistance; Change in psychotic symptoms; Change in depressive symptoms; Change in mania symptoms; Change in Clinical Global Impression (CGI) Scale

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