Bipolar Disorder Trial, Recruiting NCT06081426 Sponsor: University of Pittsburgh Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT06081426
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:

All participants must meet these criteria:

  • People aged between 18 and 40 years old
  • People who are not currently following a ketogenic (very low carbohydrate) diet

For the Bipolar Disorder (BD) – Hypomanic group:

  • People with a diagnosis of Bipolar I or Bipolar II disorder (as defined by standard psychiatric guidelines, DSM-5)
  • People who are currently in a hypomanic state, shown by scoring higher than 10 on a standard mood rating scale (the Young Mania Rating Scale)
  • People taking certain common bipolar medications, including atypical antipsychotics, lithium, antidepressants, or anti-anxiety medications (combinations are acceptable)

For the Bipolar Disorder (BD) – Euthymic (stable mood) group:

  • People with a diagnosis of Bipolar I or Bipolar II disorder (DSM-5)
  • People who are currently in a stable mood state, shown by scoring 10 or below on the Young Mania Rating Scale
  • People taking certain common bipolar medications, including atypical antipsychotics, lithium, antidepressants, or anti-anxiety medications (combinations are acceptable)

For the Healthy Control group:

  • People with no history of psychiatric illness

Who may not be able to join:

All participants:

  • People who are younger than 18 or older than 40 years of age
  • People with a history of head injury, a neurological condition, a pervasive developmental disorder (such as autism), or a significant ongoing physical illness requiring treatment
  • People who score below 24 on a standard cognitive (thinking and memory) screening test
  • People whose estimated general intellectual ability falls below a standard threshold score of 85 (assessed using a reading-based test)
  • People with significant vision problems (worse than 20/40 on a standard eye chart)
  • People with a history of alcohol or substance use disorder involving any substance including nicotine, or people who have used illicit substances (other than cannabis) in the past 6 months — note that limited cannabis use (fewer than 3 times in the past month and not at a dependency level) is permitted; cannabis use disorder within the past 6 months is not permitted; urine and saliva tests on scan days will be used to check for current substance or alcohol intoxication
  • People who cannot safely have an MRI scan — for example, those with metal implants or devices in the body, those who experience claustrophobia, or females with a positive pregnancy test or who report being pregnant
  • People who are not able to understand English
  • People with conditions affecting the pancreas, liver, thyroid, or gallbladder
  • People taking blood-thinning medications, or people with blood or clotting disorders (such as haemophilia), due to a finger-prick blood test required in the study
  • People showing signs of psychotic symptoms, indicated by a score of 3 or higher on certain questions in a standard psychiatric assessment (PANSS)
  • People currently following a ketogenic diet
  • People whose head circumference is larger than 24 inches (62 cm) or chest circumference is larger than 55 inches (139 cm)

For the Bipolar Disorder – Hypomanic group, additional exclusion criteria:

  • People whose mood rating score is 10 or below on the Young Mania Rating Scale (indicating they are not in a hypomanic state)
  • People currently in a manic or stable (euthymic) episode of bipolar disorder
  • People taking psychiatric medications other than those listed in the inclusion criteria
  • People who do not have a smartphone running iOS version 12.0 or above, or Android version 8 or later (needed for a study-related app)

For the Bipolar Disorder – Euthymic group, additional exclusion criteria:

  • People whose mood rating score is higher than 10 on the Young Mania Rating Scale (indicating they are not in a stable mood state)
  • People currently in a depressive, hypomanic, or manic episode of bipolar disorder
  • People taking psychiatric medications other than those listed in the inclusion criteria
  • People who do not have a smartphone running iOS version 12.0 or above, or Android version 8 or later

For the Healthy Control group:

  • People with any history of psychiatric illness

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 22 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: Mary Phillips, MD, University of Pittsburgh

Phone: 412-383-8206

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
Registry
ClinicalTrials.gov
Start date
12 January 2024
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Blood oxygen level-dependent (BOLD) signal at Scan 1; Blood oxygen level-dependent (BOLD) signal at Scan 2; Blood oxygen level-dependent (BOLD) signal at Scan 3; Manic symptoms at Scan 1; Manic symptoms at Scan 2; Manic symptoms at Scan 3; Fasting Glucose at Baseline; Fasting lipids at Baseline; Fasting hepatic function panel at Baseline: total protein; Fasting hepatic function panel at Baseline: albumin; Fasting hepatic function panel at Baseline: bilirubin; Fasting hepatic function panel at Baseline: liver enzyme; Fasting Glucose at halfway point through first dietary phase; Fasting lipids a...

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: 22 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