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New treatment option for Bipolar Depression
Official title Ketogenic Intervention for Bipolar Depression
ClinicalTrials.gov ID: NCT07121894
What this study is testing
- What it's testing
- 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.
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 50
You may be able to join 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...
- Depressive symptom severity of at least mild (MADRS \> 6) with steady and stable (ie, at least 2 weeks) mood stabilization (eg, lithium, valproate...
- Urine drug screen is negative except for allowable drugs that they have been prescribed, such as benzodiazepines.
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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).
What rules you out
- 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...
- Currently undergoing ECT, transcranial magnetic stimulation, or deep brain stimulation as an acute or maintenance treatment. Maintenance vagal nerve stimulation is allowed if the placement of device is \> 1 year.
- Current involuntary psychiatric hospitalization.
- Already in ketosis or on a medication that causes acidosis, such as carbonic anhydrase inhibitors (e.g., acetazolamide "Diamox" and topiramate).
- BMI \ 190.
- Any active or unstable medical condition judged by the principal investigator as conferring significant medical risk to allow inclusion in the study, such as active severe infection.
- Acute pancreatitis or history of lipid-associated pancreatitis.
- Type I diabetes.
- SGLT2 inhibitor use
- Rare inborn errors of metabolism affecting fatty acid processing (typically diagnosed in infancy or, rarely, adolescence), such as Pyruvate carboxylase deficiency and Porphyria
- Primary carnitine deficiency
- Chronic renal failure, significant renal disease defined as creatinine clearance \<30 or in dialysis.
- Severe vitamin D deficiency (serum levels of 25-hydroxyvitamin D [25(OH)D] \< 12 ng/mL or 30 nMol/L).
- A diagnosis of osteopenia, defined as a bone mineral density (BMD) T-score between -1.0 and -2.5 on a dual-energy X-ray absorptiometry (DEXA) scan or with a history of fragility fractures
- Clinically significant laboratory test abnormality
- Anticipated elective surgical procedure within the next 18 weeks
- Family history of premature coronary artery disease defined as atherosclerotic cardiovascular events (e.g., heart attack, stroke) before 55 and 65 years of age in male and female first-degree relatives, respectively.
- History of familial hypercholesterolemia (note -current or start of statin or lipid-lowering drug as part of clinical care is not an exclusion provided managed by a primary care provider) or LDL-C\>190 mg/dl (or...
- History of coronary disease or coronary calcifications or coronary stenosis found in invasive cardiac catheterization or imaging.
- History of ischemic stroke or carotid plaque found on baseline common carotid intima-media thickness (IMT) ultrasound.
- History of peripheral atherosclerotic arterial disease or any other form of clinical atherosclerosis.
- History or current diagnosis of respiratory failure defined as a PaO₂ \< 60 mmHg or SpO₂ \< 90% on room air or any condition leading to clinically significant respiratory impairment
- History or current diagnosis of liver failure or chronic liver disease with significant impairment, defined as ALT or AST \> 5 times the upper limit of normal, or total bilirubin \> 3 mg/dL.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, 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 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, 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.