RecruitingBipolar Depression
Ketogenic Intervention for Bipolar Depression
Eligible age
18–50 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The purpose of this study is to assess the clinical correlates of therapeutic precision ketosis in bipolar depression and to evaluate the cardiometabolic correlates associated with therapeutic precision ketosis in bipolar depression.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ Age 18-50 years
- ✓ Willingness to change the current diet to a high fat, low carbohydrate diet
- ✓ Diagnosis of bipolar I or II disorder, or BP schizoaffective Disorder by DSM-IV (SCID- confirmed). If a participant has already completed a structured diagnostic interview within the last 2 years or in any of the Department of Psychiatry and Psychology Mood Unit studies, existing SCID results can be used for this study; thus, they will not be required to repeat the SCID assessment. If a structured diagnostic interview was completed more than 2 years ago, the current mood state sections of the SCID must be repeated to ensure accuracy of current mood state assessment.
- ✓ Depressive symptom severity of at least mild (MADRS \> 6) with steady and stable (ie, at least 2 weeks) mood stabilization (eg, lithium, valproate, lamotrigine, carbamazepine/oxcarbamazepine, and/or atypical antipsychotic therapy) and non-psychotropic medication.
- ✓ Urine drug screen is negative except for allowable drugs that they have been prescribed, such as benzodiazepines.
- ✓ Pregnancy test is negative.
- ✓ Established birth control practice for sexually active individuals.
- ✓ Medical comorbidity is stable (hypertension, T2D, gout - uric acid in normal limits).
You may not qualify if…
- ✕ No access to smartphone or internet (unless provided by sponsor)
- ✕ Inability to provide written, voluntary, informed consent and pass (80%) comprehension assessment related to study goals, risks, and benefits.
- ✕ Structured clinical interview confirmation of schizophrenia or presence of psychotic symptoms (both SCID and YMRS question 8\>5).
- ✕ Clinical diagnosis of personality disorder that, upon review by the study psychiatrist, of all available information (SCID, electronic health record), is the primary psychiatric diagnosis.
- ✕ Mixed symptoms of depression defined as a YMRS ≥12 (i.e., hypomania).
- ✕ Active suicidal ideation as defined by MADRS score \>4 on question #10 or Columbia Suicide Severity Scale (C-SSRS), yes response to Question #4 (ideation, intent, but no plan) or Question #5 (ideation, intent, and plan).
- ✕ Any current drug and alcohol use disorder (excluding nicotine); complete (not partial) remission ≥3 months.
- ✕ Positive toxicology screen for cannabis and cannabis use disorder by structured clinical interview. Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included if the Cannabis Use Disorder Identification Test (CUDIT-R) score is \< 12.
Where it's recruiting
Minnesota
Rochester
Source: ClinicalTrials.gov · NCT07121894 · last updated 2026-01-26