Bipolar Disorder study: Glucose vs Ketones
Official title Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
ClinicalTrials.gov ID: NCT06373016
What this study is testing
- What it's testing
- This study is testing how sugar and ketones change brain activity. It looks at how these fuels affect how you handle risk and reward.
- Who it's for
- You may be able to join if you have bipolar disorder or if you do not have it.
- What's involved
- You would give a blood sample. You would have two MRI scans on different days. You would drink sugar or ketones before playing games.
- Time commitment
- The study involves two separate MRI scan days and a blood test.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Inclusion/
You likely can't join if
- Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical...
- Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks
- Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls
- Weight does not exceed 350lbs.
- Diameter does not exceed 60 cm when supine
- HbA1C \< 7%
See the full eligibility criteria
- Inclusion/
- Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)
- Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks
- Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls
- Weight does not exceed 350lbs.
- Diameter does not exceed 60 cm when supine
- HbA1C \< 7%
- No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)
- No claustrophobia
- No history of significant head injury
- No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
- No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation
- Are not deemed a serious suicide or homicide risk
- No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- No seizure disorders
- Have the capacity to sign informed consent
- No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed...
- For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease
- Must have vision that is 20/20 or correctable to 20/20 with contact lenses
- No Type 1 diabetes mellitus
- No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.
- No kidney disease, as determined by medical history and/or blood work
- No history of heart attack or stroke
- No difficulty swallowing
- No myxedema
- No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test
- No breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Belmont, Massachusetts, United States
- Charlestown, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Belmont, Massachusetts, United States; Charlestown, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.