Bipolar Disorder study: Non-ketogenic Diet vs Ketogenic Diet
Official title Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
ClinicalTrials.gov ID: NCT06081426
What this study is testing
- What it's testing
- The researchers want to learn how this specific diet changes brain function, energy use, and feelings in people with bipolar disorder.
- Who it's for
- The study is looking for adults who have been diagnosed with bipolar disorder.
- What's involved
- Participants will follow a ketogenic diet and undergo tests to measure brain activity, metabolism, and emotional state.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
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 40. Healthy volunteers may be eligible.
You may be able to join if
- 18-40 years of age
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
- Score greater than 10 on the Young Mania Rating Scale score(YMRS)
- BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common...
You likely can't join if
- Not between 18-40 years of age
- History of head injury, neurological, pervasive developmental disorder (e.g.
- Mini-Mental State Examination score (cognitive state) \<24
- Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85
- Visual disturbance: \<20/40 Snellen visual acuity
- History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6...
See the full eligibility criteria
- 18-40 years of age
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)
- Score greater than 10 on the Young Mania Rating Scale score(YMRS)
- BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
- Meeting sex proportion: 50% female
- Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)
- Score less than or equal to 10 on YMRS
- BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)
- Sex matched with BD groups
- No psychiatric history
- Not between 18-40 years of age
- History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
- Mini-Mental State Examination score (cognitive state) \<24
- Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85
- Visual disturbance: \<20/40 Snellen visual acuity
- History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5).
- MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
- Unable to understand English
- Conditions related to the pancreas, liver, thyroid or gallbladder.
- Taking anticoagulants and/or those with blood dyscrasias (illnesses) who have coagulation disorders (eg, hemophilia) because of the ketomojo finger stick blood tests
- Scoring 3 or higher on positive symptom factor questions on the Positive and Negative Syndrome Scale (PANSS) questionnaire (indicative of psychotic symptoms)
- Currently following a ketogenic diet
- Head circumference larger than 24 inches (62cm) and/or chest circumference larger than 55 inches (139 cm)
- Must be meeting sex proportions: not 50% female
- Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5)
- Diagnosis of BD in a manic or euthymic episode
- Score 10 or lower on the Young Mania Rating Scale score(YMRS)
- Using psychotropic medications other than those allowed in inclusion criteria
- Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
- Not meeting sex proportion: not 50% female
- Not meeting diagnosis proportion: not 50:50% BDI:II
- Diagnosis of BD in a depressive, hypomanic, or manic episode
- Score greater than 10 on YMRS
- Using psychotropic medications other than those allowed in inclusion criteria
- Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
- Does not have a primary care provider (if enrolled in ketogenic diet phase) Healthy Control (HC) Group
- Not sex-matched with BD groups
- Has psychiatric history
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, 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 40 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 Pittsburgh, Pennsylvania, 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.