New depression pill shows promise in large trial
NCT ID NCT04984512
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests a new drug called mitizodone phosphate in 600 adults with major depression. The goal is to see if it reduces depression symptoms better than a placebo over 8 weeks. The trial has two phases: first to find the best dose, then to confirm how well it works and if it's safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunshine Lake Pharma Co., Ltd.
RECRUITINGDongguan, Guangdong, 523871, China
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