2-panel, Double-blind, Randomized, Multicenter study to Evaluate the Drug blood concentration, Efficacy and Safety of D-Beta hydroxybutyrate in Healty male volunteer and Patients with Depression
D-Beta hydroxybutyrate Clinical Study
Iwata Masaaki
Tottori University Hospital
36-1 Nishi-cho, Yonago, Tottori Japan
+81-859-38-6547
yanmasa@f8.dion.ne.jp
Endo Yusuke
Tottori University Hospital
36-1 Nishi-cho, Yonago, Tottori Japan
+81-859-38-6946
y-endo@tottori-u.ac.jp
Complete
June. 16, 2020
416
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
Healthy male volunteer (Part A)
1) 20 to 60 years old Japanese male
2) Subject who was judged healthy by investigator
3) Subject who have a regular diet
Depression patient (Part B)
1) 20 years old above male or female
2) At the start of the screening visit, patient must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for depression
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) Patient who have a regular diet
5) Patient must be medically stable on the basis of assessment and observation performed in the screening visit
6) Patient give informed consent
Healty male volunteer (Part A)
1) Subject have history of drug sensitivity
2) Subject who had other study drug, non-approved and pff-label drug within 3 months before enrollment
3) Subject who donate blood
4) Subject who have surgery that might influence the drug absorption
5) Subject with drug addict or alcohol abuse
6) Subject have history of sychiatric disease
7) Subject with excessive alcohol drinking and smoking
8) Subject with allergy to pineapple
9) Subject who have a carbohydrate-restricted diet
10) Subject who do not agree to refrain from excessive exercise during the study drug administration
10) Subject who or whose partners are unwilling to agree to practice appropriate contraception during the study period
Depression patient (Part B)
1) Patient with moderate or higher infection
2) Patient with is drug addic
3) Patient have history of suicidal ideation or suicide attempt
4) Patient who adminster anti-inflammatory drug, immune-suppressing drug or steroid
5) Patient with malignancy
6) Patient with severe organ disorder (cardiovascular disturbance, liver and kidney)
7) Patient with diabetes
8) Patient with dementia or sychiatric disease other than depression
9) Patient with allergy to pineapple
10) Patient who have a carbohydrate-restricted diet
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, non-approved and pff-label drug within 3 months before enrollment
20age old over
No limit
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) Dose dependent
2) Percentage of Responders
3) Proportion of Remitters
4) Proportion of Participants Showing Onset of Clinical Response
5) Clinical Global Impression-Severity (CGI-S)
6) Clinical Global Impression-Improvement (CGI-I)
7) Generalized Anxiety Disorder 7-Item Scale (GAD-7)
8) Depressive Symptomatology
9) Quality of sleep
10) Degree of stress
11) Biomarker in blood
12) Safety
13) Blood concentration of D-Beta hydroxybutyrate
14) Relationship between clinical evaluation data and age, etc.
OSAKA GAS CO.,LTD.
Not applicable
Certified Review Board, Tottori University Hospital
