Ketogenic Intervention for Bipolar Depression
ConditionBipolar Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ketogenic Diet
BehavioralParticipants will initiate a modified ketogenic diet under structured, intensive guidance. Simultaneously, participants will attend weekly behavioral support interviews with a psychiatrist to monitor mental health and mood stability.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Ketogenic DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in depressive symptoms
Measured using the Quick Inventory for Depressive Symptomatology Clinician Rated (QIDS-C), a 16-item clinician rating, each rated on a four-point Likert scale (0-3). The total score ranges from 0 to 27. The QIDS-C is scored by summing the responses to the 16 items, with higher scores indicating more severe symptoms.
Time frame
Baseline, 6 monthsSecondary outcomes
1
Response and Remission Rates
Measured using the Montgomery-Asberg Depression Rating Scale (MADRS), with response defined as a ≥50% reduction from baseline symptoms and remission as a score \<10, providing complementary measures of symptom improvement. MADRS is a 10-item observer rating scale assessing symptoms of depression. The MADRS will be used to assess depression severity, exclude patients with suicidal ideation scoring \> 4 on question #10 and measure % of patients achieving remission defined as a MADRS \< 10.
Time frame
Baseline, 6 months2
Percentage of clinically significant improvement
The proportion of participants rated as "much improved" or "very much improved" on the Clinical Global Impression for Bipolar Disorder (CGI-BP) scale. CGI-BP is a specialized tool for assessing the severity, treatment response, and efficacy of interventions in bipolar disorder. It addresses the unique features of the disorder by evaluating manic and depressive episodes separately. It consists of three components: Severity of Illness (CGI-BP-S), Global Improvement (CGI-BP-I), which tracks changes from baseline; and Efficacy Index (CGI-BP-E), which assesses treatment benefits relative to side effects.
Time frame
Baseline, 6 months3
Change in anxiety symptoms
Measured using the General Anxiety Disorder 7 (GAD-7), a 7-item self-report questionnaire used to measure the severity of generalized anxiety symptoms over the past two weeks. Each item is scored on a 4-point Likert scale (0 = "Not at all" to 3 = "Nearly every day"), with a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity
Time frame
Baseline, 6 months4
Prevalence rate of disordered eating
Measured using the Eating Disorder Diagnostic Scale (EDDS), a standardized measure designed to assess symptoms of eating disorders. It quantifies symptom severity and provides a diagnostic algorithm based on threshold scores that indicate probable diagnoses and subthreshold levels of disordered eating. The EDDS includes 22 items that evaluate key behaviors and cognitive symptoms associated with eating disorders.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov