The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total scores from baseline to week 6.
A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment. The subjects will accept the drug treatment twice daily orally for 6 weeks. During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
Placebo tablets will be given orally, twice daily, for 6 weeks
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline in MADRS scores,the \*total\* score ranges\[0,60\],higher values represent a worse outcome
Time frame: Baseline,43 days after treatment
Hamilton Depression Scale 17 items(HAMD17)
Change from baseline in HAMD17 scores,the \*total\* score ranges\[0,50\],higher values represent a worse outcome
Time frame: Baseline,43 days after treatment
Hamilton Anxiety Rating Scale (HAM-A)
Change from baseline in HAM-A scores,the \*total\* score ranges\[0,56\],higher values represent a worse outcome
Time frame: Baseline,43 days after treatment
Clinical Global Impression of Severity Scale(CGI-S)
Change from baseline in CGI-S scores,the \*total\* score ranges\[0,7\],higher values represent a worse outcome
Time frame: Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Clinical Global Impression of Improvement Scale(CGI-I)
the \*total\* score ranges\[0,7\],higher values represent a worse outcome
Time frame: 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in Digit Symbol Substitution Test (DSST)
Time frame: Baseline, 43 days after treatment
Change in Trail Making Test Parts A&B (TMT)
Time frame: Baseline, 43 days after treatment
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...and 9 more locations