This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.
Age: 18 to 65 years old (inclusive), Male or female.
Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2/296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month
Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).
Patients must have a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline
Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.
A reduction of ≥25% in MADRS total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).
A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;
An answer of "Yes" to Question 4 (active suicidal ideation with intent without specific plan) or Question 5 (active suicidal ideation with specific plan and intent) of the C-SSRS within the past 6 months at screening, or a suicide-related behavior within the past 6 months (any "Yes" response for Actual Attempt, Interrupted Attempt, or Aborted Attempt).
Parallel
KH607 tablets
Drugoral 20mg, once daily for 21 days.
Vortioxetine Hydrobromide Tablets
Drugoral 10mg, once daily for 42 days.
Part B: KH607
Drugoral 20mg, once daily for 21 days.
short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
short-term study: Change From Baseline in the MADRS Total Score
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
short-term study: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score
The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression.
short-term study: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores.
short-term study: Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
The CGI-S item employed a 7-point Likert scale to measure the overall severtity in the participant's condition.
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