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New treatment option for Bipolar Disorder
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 investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
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
- All participants:
- 18-40 years of age
- Not following a ketogenic diet BD hypomanic group (n=30):
- 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)
You likely can't join if
- All participants:
- 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...
- 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
See the full eligibility criteria
- All participants:
- 18-40 years of age
- Not following a ketogenic diet BD hypomanic group (n=30):
- 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) BD euthymic group (n=30):
- 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) Healthy Control (HC) Group (n=30):
- Sex matched with BD groups
- No psychiatric history
- All participants:
- 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). Note: lifetime/present cannabis use (at non-abuse (\<3...
- 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) BD hypomanic group:
- 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 BD euthymic group:
- 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 Healthy Control (HC) Group
- Not sex-matched with BD groups
- Has psychiatric history
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.