臨床研究等提出・公開システム

Double-blind, randomized, exploratory, multicenter clinical study to evaluate the efficacy and safety of D--Beta hydroxybutyrate in depressed patients

D-Beta hydroxybutyrate Clinical Study

Iwata Masaaki

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

yanmasa@f8.dion.ne.jp

Endo Yusuke

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori

+81-859-38-6946

y-endo@tottori-u.ac.jp

Recruiting

Sept. 29, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) 20 years old above male or female
2) Patient who have a diagnosis of depression based on the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) at the start of screening visit and are attending outpatient clinic
3) Patient must administer less than 2 antidepressant with optimum dose within 28 days of enrollment, and must be stable of depression symptom and meet the depression symptom severity (MADRS total score greater than or equal to 22) at the enrollment.
4) If the patient has received sleeping or anxiolytic medications (including those taken by tonics) in the 14 days prior to the start of the double-blind period, the dosage and administration must not have been changed.
5) Patient who have a regular diet
6) Patient must be medically stable on the basis of assessment and observation performed in the screening visit
7) Patient give informed consent

1) Patient with moderate or higher infection
2) Patient with is drug addic
3) Patients with imminent suicidal thoughts or a history of suicide attempts between the date consent was obtained and the administration of the study drug.
4) Patients receiving anti-inflammatory drugs, immunosuppressants, SGLT2 inhibitors, or steroids. However, the local use of anti-inflammatory drugs, immunosuppressants, or steroids, as well as the as-needed use of anti-inflammatory drugs, is permitted.
5) Patient with malignancy
6) Patient with severe organ disorder (cardiovascular disturbanc
7) Patient with diabetes
8) Patient with dementia or sychiatric disease other than depression
9) Patient who have a carbohydrate-restricted diet
10) Patients requiring potassium intake restriction
11) Subject who do not agree to refrain from excessive exercise during the study drug administration
12) Patient who are preg nant or nursing or who desire to become pregnant during the study period. Patients who or whose partners are unwilling to agree to practice appropriate contraception during the study period
13) Patient who had other study drug
14) Patients deemed by the principal investigator to be ineligible for inclusion.

Both

Depression

D-Beta hydroxybutyrate administration

Change in MADRS Total Score as Measured by the Change From Baseline to the end of the 8-Week.

1) Change over time in MADRS total score
2) Dose dependent
3) Percentage of Responders
4) Proportion of Remitters
5) Amount of change in MADRS subitem scores
6) Clinical Global Impression-Severity (CGI-S)
7) Clinical Global Impression-Improvement (CGI-I)
8) Generalized Anxiety Disorder 7-Item Scale (GAD-7)
9) Depressive Symptomatology
10) Degree of stress
11) Biomarker in blood
12) Safety

+81-859-38-7021

June. 20, 2023

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