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 score from baseline to week 6.
A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments 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
NONE
Enrollment
42
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks
Shanghai mental health center
Shanghai, Shanghai Municipality, China
Change in 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: Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in 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,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in 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, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment
Change in 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
Change in 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
Columbia-Suicide Severity Rating Scale (C-SSRS)
Safety index,no total score
Time frame: Baseline,15 day after treatment,43 day after treatment
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