Mitizodone Phosphate tablets for major depressive disorder

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

This study will try Mitizodone Phosphate tablets in adults with major depressive disorder to see if they improve depressive symptoms compared with placebo.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sunshine Lake Pharma Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Dongguan, Guangdong)
• Trial ID: NCT04984512 on ClinicalTrials.gov

What this trial studies

This is an adaptive phase 2/3, double-blind, randomized, placebo-controlled study that first uses an 8-week phase 2 dose-finding period across three Mitizodone dose groups and placebo. The optimal dose identified in phase 2 will be carried forward into an 8-week phase 3 confirmatory period to compare efficacy and safety against placebo. Eligible participants must meet DSM-5 criteria for major depressive disorder and have moderate-to-severe symptom scores (MADRS ≥26 and CGI-S ≥4). Key exclusions include psychotic features, bipolar disorder, schizophrenia, substance dependence, and significant neurological or serious medical conditions.

Who should consider this trial

Good fit: Adults with major depressive disorder per DSM-5 who have moderate-to-severe symptoms (MADRS ≥26 and CGI-S ≥4) and do not have psychotic features or major comorbid psychiatric or neurological disorders are ideal candidates.

Not a fit: People with psychotic depression, bipolar disorder, schizophrenia, active substance abuse or dependence, significant neurological disease, or serious uncontrolled medical conditions are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, Mitizodone could become a new oral option that reduces depressive symptoms for people with moderate-to-severe major depressive disorder.

How similar studies have performed: Randomized, double-blind, placebo-controlled dose-finding followed by confirmatory trials are a common pathway for antidepressants, though Mitizodone itself is novel and unproven.

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.

Where this trial is running

Dongguan, Guangdong

• Sunshine Lake Pharma Co., Ltd. — Dongguan, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: gang wang, Ph.D

Conditions Depressive Disorder, Major