The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder

NCT04984512 | Recruiting Phase 2 DMC

• 1 other identifier: HEC113995-P-5
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8

  The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement.

  baseline and week 8

Secondary Outcomes (6)

• Percentage of subjects With a MADRS Response at Week 8

  baseline and week 8

• Percentage of Participants in MADRS Remission at Week 8

  week 8

• Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1、week 2 、week 4、week 6.

  baseline 、 week 1、week 2 、week 4 and week 6.

• 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.

  baseline、week 1、week 2 、week 4、week 6 and week 8.

• Clinical Global Impression - Improvement (CGI-I) Score at week 1、week 2 、week 4、week 6、Week 8

  week 1、week 2 、week 4、week 6 and week 8.

Study Arms (4)

Mitizodone Phosphate tablet 10mg

EXPERIMENTAL

Mitizodone Phosphate tablet 10mg ,orally,once daily for 8 weeks, then placebo,orally,once daily for 2 weeks.

Drug: Mitizodone Phosphate tablets

Mitizodone Phosphate tablet 20mg

EXPERIMENTAL

Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 7 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then placebo,orally,once daily for 1 weeks.

Drug: Mitizodone Phosphate tablets

Mitizodone Phosphate tablet 40mg

EXPERIMENTAL

Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 40mg ,orally,once daily for 6 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks.

Drug: Mitizodone Phosphate tablets

Placebo

ACTIVE COMPARATOR

Placebo,tablet,orally,once daily for 10 weeks.

Drug: Placebo-matching tablets

Interventions

Mitizodone Phosphate tablets DRUG

Mitizodone Phosphate tablets will be administered with food.

Also known as: HEC113995PA•H2O

Mitizodone Phosphate tablet 10mg; Mitizodone Phosphate tablet 20mg; Mitizodone Phosphate tablet 40mg

Placebo-matching tablets DRUG

Placebo will be administered with food.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
• Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

You may not qualify if:

• has major depressive disorder with psychotic features according to the DSM-5.
• 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.
• Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).
• \. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.
• \. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).
• \. Current or history of angle-closure glaucoma.
• \. 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 .
• has taken fluoxetine within 4 weeks prior to initial dosing.
• \. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.
• has psychotherap at Screening and/or Baseline Visits.
• has had physiotherapy within 3 months prior to initial dosing.
• Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
• 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.
• Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.
• Has a history of severe allergies.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Sunshine Lake Pharma Co., Ltd.

Dongguan, Guangdong, 523871, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

gang wang, Ph.D

CONTACT

86-010-58303236; gangwangdoc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)