Major Depressive Disorder/Bipolar Disorder
Conditions
Interventions
Ketogenic Diet Intervention Group:Ketogenic Diet Intervention: Participants first undergo a one-week titration phase of the ketogenic diet, followed by a stable continuation of treatment for 12 weeks.
it can be taken with meals or combined with food (note that it should not be consumed all at once in one day to avoid gastrointestinal intolerance).
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old; 2. Diagnosed with Major Depressive Disorder or Bipolar Disorder according to the DSM-5 criteria, and assessed as such using the Structured Clinical Interview for DSM-5 Disorders (SCID-5); 3. Clinically stable, with no hospitalization due to psychiatric symptoms in the past 12 weeks and stable use of psychiatric medications (without changes in medication types or dosages); 4. Overweight or obese (BMI = 25 kg/m²); 5. Willing and able to follow a ketogenic diet plan; 6. Capable of understanding the research procedures and willing to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of suicidal behavior or current active suicidal ideation or behavior (HAMD-17 suicide item score > 2); 2. Currently in an unstable phase of the disease, such as acute manic episodes, active suicide requiring hospitalization, with severe psychotic symptoms, etc.; 3. Suffering from schizophrenia, severe cognitive impairment, or other severe mental disorders, eating disorders; 4. History of alcohol or drug dependence, not abstinent within the past 6 months; 5. Suffering from severe physical illnesses, such as heart, kidney, liver disease, diabetes, and other inherited metabolic diseases, such as abnormal peripheral blood carnitine levels, primary carnitine deficiency, carnitine palmitoyltransferase (CPT) I and II deficiency, carnitine translocase deficiency, beta-oxidation disorders, medium-chain acyl-CoA dehydrogenase deficiency (MCAD), very long-chain acyl-CoA dehydrogenase deficiency (VLCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), short-chain acyl-CoA dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, porphyria, type 1 diabetes (Note: These inherited metabolic diseases usually manifest in infancy or childhood, and most are identified and diagnosed during childhood, often through medical history to determine if such diseases are present); 6. Allergic reactions to common food ingredients in the ketogenic diet; 7. Breastfeeding, pregnant patients, or those planning to become pregnant during the study period; 8. Participation in other dietary or lifestyle intervention studies that may affect mood states; 9. The researcher believes there are other reasons that make participation in this study unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolism indicators;YMRS;HAMA;Cognitive function;WHOQOL-BREF;HAMD-17; | — |
Countries
China
Contacts
Public ContactYanling Zhou
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed