Mitizodone Phosphate tablets for major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: gang wang, Ph.D
• Email: gangwangdoc@gmail.com
• Phone: 86-010-58303236

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brenipatide added to standard care for adults with major depressive disorder

  This study tests whether brenipatide, given alongside standard care, can help delay the return of depressive symptoms in adults with major depressive disorder.

  Recruiting at 47 sites Phase 3 Eli Lilly and Company · Birmingham, Alabama and 169 other locations · NCT07775300

• Student Precarity and Psychiatry: How Financial Struggles Relate to Depression and Loneliness

  This observational study looks at whether financial hardship and social isolation are linked to depression, suicidal thoughts, and loneliness among French university students.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, IDF · NCT07618208

• Seltorexant (JNJ-42847922) as monotherapy for adults and older adults with major depressive disorder

  This trial will test whether seltorexant works better than a placebo to reduce depressive symptoms in adults and elderly people with major depressive disorder.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Bryant, Arkansas and 52 other locations · NCT07573176

• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

  This study tests a collaborative mental health program for pregnant or recently postpartum patients hospitalized for medical problems to see if it can be delivered feasibly and acceptably.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07540585

• Brenipatide added to standard antidepressant treatment for adults with major depression

  This trial will see if adding brenipatide to your current antidepressant treatment can delay the return of major depressive symptoms in adults with major depressive disorder.

  Recruiting at 170 sites Phase 3 Eli Lilly and Company · Moorpark, California and 179 other locations · NCT07412756

• Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

  This will test whether adding intranasal esketamine to usual care helps hospitalized adolescents with major depressive disorder and acute suicidal thoughts or behavior feel better faster than a psychoactive placebo plus usual care.

  Recruiting at 49 sites Phase 3 Janssen Research & Development, LLC · Birmingham, Alabama and 48 other locations · NCT07227454

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.