The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
In this study, a randomized, double-blind, duloxetine hydrochloride enteric coated capsule positive and placebo-controlled multicenter study was used to evaluate the efficacy and safety of different doses of amxetine hydrochloride enteric coated tablets in the treatment of depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Ammoxetine hydrochloride enteric-coated tablets
Duloxetine hydrochloride enteric-coated capsules
Placebo to Ammoxetine
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGChange from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 6)
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement. Change = (Week 6 post-dose score - baseline week 0 score). at the end of treatment (week 6)
Time frame: Baseline and week 6
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6
The HAMD-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. Change = (Week 1, 2, 4 and 6 post-dose score - baseline week 0 score).
Time frame: Baseline, week 1, 2, 4 and 6
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6
The HAMA is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAMA total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. Change = (Week 1, 2, 4 and 6 post-dose score - baseline week 0 score).
Time frame: Baseline, week 1, 2, 4 and 6
Change from baseline in CGI-S score at week 1, 2, 4, 6,7
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. Change = (Week 1, 2, 4, 6 and 7 post-dose score - baseline week 0 score).
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Placebo to Duloxetine
Time frame: Baseline, week 1, 2, 4, 6 and 7
The percentage of subjects with a MARDS score reduction ≥ 25%
The score reduction rate is defined as (screening period MARDS scale score - post-dose MARDS scale score)/screening period MARDS scale score x 100%.
Time frame: Week 1 and 2
Incidence of adverse events (AE)
The AEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
Time frame: Throughout the study period,an average of 18 months
Change from baseline in MADRS score at week 1, 2, 4
Change = (Week 1, 2 and 4 post-dose score - baseline week 0 score).
Time frame: baseline, week 1, 2 and 4