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Recruiting NCT04984512

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

Phase II / Phase III Interventional Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mitizodone Phosphate tablets, Placebo-matching tablets.
Who it may be relevant to
Registry conditions: Depressive Disorder, Major. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Mitizodone Phosphate tablets
    Mitizodone Phosphate tablets will be administered with food.
  • Drug Placebo-matching tablets
    Placebo will be administered with food.

Primary outcome measures

  • Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8 [Time frame: baseline and week 8]
Secondary outcome measures (6)
  • Percentage of subjects With a MADRS Response at Week 8 [Time frame: baseline and week 8]
  • Percentage of Participants in MADRS Remission at Week 8 [Time frame: week 8]
  • Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1、week 2 、week 4、week 6. [Time frame: 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. [Time frame: 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 [Time frame: week 1、week 2 、week 4、week 6 and week 8.]
  • Change From Baseline in the hamilton anxiety rating scale （HAM-A）Total Score at week 1、week 2 、week 4、week 6、week 8. [Time frame: baseline、week 1、week 2 、week 4、week 6 and week 8.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sunshine Lake Pharma Co., Ltd. — Dongguan

Identifiers

NCT: NCT04984512 · HEC113995-P-5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗