Health Trialsby

Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

ConditionsSchizophrenia Schizophrenia and Related Disorders Bipolar Disorder Bipolar and Related Disorders Major Depressive Disorder Major Depression Severe Ketogenic Dieting Ketosis Metabolic Disease Metabolic Syndrome

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorStanford University

About this trial

The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia

Meet DSM V criteria for BD (any subtype)

Not mild

>40 on BPRS

Disqualifiers

has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll

pregnant or nursing

insulin dependent

comorbidity of developmental delay

Trial design

Design model

Parallel

Treatments tested in this trial

LCHF Ketogenic Diet
Other intervention
Low Carbohydrate, Moderate Protein, High Fat (LCHF) Ketogenic Dietary Intervention for 12 weeks
Diet-as-Usual (DAU)
Other intervention
Participant's usual diet

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Arm 1: Ketogenic Diet OnlyExperimental treatment 1 intervention

Group B: Arm 2: DAU- Ketogenic Diet CrossoverExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

WHO-5 Well-being Index

Change in general well-being from baseline. Self reported to measure quality of life. Assessed on 5-items, scored from 0-5 on each item, with higher scores indicating better quality of life.

Time frame

Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

2

Functioning Assessment Short Test (FAST)

Change in quality of life from baseline. Self reported and assessed on 24-items regarding difficulties in the experiences described. Scored from 0-3 on each item, with lower composite scores indicating better quality of life.

Time frame

Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

3

Quality of Life Scale (QIDS)

Change in severity of depression from baseline. Self reported on 16 items with a composite score range of 0-27 (0= no depression, 27 = very severe depression).

Time frame

Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

Secondary outcomes

1

Cambridge Cognition (CANTAB Assessment)

Change in cognition and brain health assessment from baseline. Scored by assessment's algorithm that compares scores within the established benchmark by age group and test. (≥ 1.5 SD below normative means = insufficient performance, ≥1 SD below normative means = subtle impaired performance in task)

Time frame

Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

2

Quality of Life in Neurological Disorders (Neuro-QOL, Cognitive Function)

Change in quality of life related to cognitive function from baseline. T-score 17.3- 38.9 (high scores indicate better/desirable self-reported health).

Time frame

Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

3

Brief Psychiatric Assessment Scale (BPRS)

change in severity of psychopathy; 18 conditions scored by clinician. Each of the 18 conditions/outcomes rated from 0-7 (0= not assessed, 7 = extremely severe).

Time frame

Screening; Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

4

Patient Health Questionnaire (PHQ-9)

Change in Depression; 9-10 items scored on composite score range 0-27 (0= no depression, 27= severe depression).

Time frame

Screening; Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: