Actively Recruiting
The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-05-05
600
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with major depressive disorder (MDD) according to DSM-5 criteria
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at screening and baseline
- Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at screening and baseline
You will not qualify if you...
- Major depressive disorder with psychotic features
- Current or history of bipolar disorder, schizophrenia, anxiety disorder, insomnia, substance abuse or dependence, or other psychiatric disorders
- Current or history of significant neurological disorders including epilepsy, Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease
- Serious medical diseases such as neurological, cardiovascular, hepatic, renal, blood system, or endocrine disorders
- Current or history of cancer except basal cell skin cancer and preinvasive carcinoma of cervix uteri
- Current or history of angle-closure glaucoma
- Suicide behavior within the past year or a score of 4 or more on item 10 (suicidal thoughts) of MADRS
- Use of fluoxetine within 4 weeks prior to initial dosing
- Use of other antidepressant or antipsychotic medications within 2 weeks prior to initial dosing
- Psychotherapy at screening or baseline visits
- Physiotherapy within 3 months prior to initial dosing
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels greater than 1.5 times the upper limit of normal
- Alanine aminotransferase or aspartate aminotransferase levels greater than 2 times the upper limit of normal; or total bilirubin, direct bilirubin, creatinine levels greater than 1.5 times the upper limit of normal; or abnormal thyroid stimulating hormone
- Abnormal electrocardiogram considered clinically significant
- History of severe allergies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunshine Lake Pharma Co., Ltd.
Dongguan, Guangdong, China, 523871
Actively Recruiting
Research Team
G
gang wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here