Clinical trial NCT04984512: The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder
Official title: A Phase II/III ,Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Adaptive Design Study Evaluating the Efficacy And Safety of Mitizodone Phosphate Tablets in the Treatment of Patient With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.


Eligibility criteria: Inclusion Criteria:

* 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33)
* 2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
* 3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

* 1.has major depressive disorder with psychotic features according to the DSM-5.
* 2.Current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the DSM-5.
* 3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).
* 4. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.
* 5. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).
* 6. Current or history of angle-closure glaucoma.
* 7. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of MADRS .
* 8.has taken fluoxetine within 4 weeks prior to initial dosing.
* 9. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.
* 10.has psychotherap at Screening and/or Baseline Visits.
* 11.has had physiotherapy within 3 months prior to initial dosing.
* 12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
* 13.Has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range.
* 14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.
* 15.Has a history of severe allergies.

Primary outcomes:
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8
timeFrame: baseline and week 8
Secondary outcomes:
measure: Percentage of subjects With a MADRS Response at Week 8
timeFrame: baseline and week 8
measure: Percentage of Participants in MADRS Remission at Week 8
timeFrame: week 8
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1、week 2 、week 4、week 6.
timeFrame: baseline 、 week 1、week 2 、week 4 and week 6.
measure: Change From Baseline in the Clinical Global Impression - Severity of illness (CGI-S) Total Score at week 1、week 2 、week 4、week 6、week 8.
timeFrame: baseline、week 1、week 2 、week 4、week 6 and week 8.
measure: Clinical Global Impression - Improvement (CGI-I) Score at week 1、week 2 、week 4、week 6、Week 8
timeFrame: week 1、week 2 、week 4、week 6 and week 8.
measure: Change From Baseline in the hamilton anxiety rating scale （HAM-A）Total Score at week 1、week 2 、week 4、week 6、week 8.
timeFrame: baseline、week 1、week 2 、week 4、week 6 and week 8.
Other outcomes:
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