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

20 augustus 2026 bijgewerkt door: Sunshine Lake Pharma Co., Ltd.

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 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

600

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523871
        • Werving
        • Sunshine Lake Pharma Co., Ltd.
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mitizodone Phosphate tablet 10mg
Mitizodone Phosphate tablet 10mg ,orally,once daily for 8 weeks, then placebo,orally,once daily for 2 weeks.
Geneesmiddel: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Andere namen:
  • HEC113995PA•H2O
Experimenteel: Mitizodone Phosphate tablet 20mg
Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 7 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then placebo,orally,once daily for 1 weeks.
Geneesmiddel: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Andere namen:
  • HEC113995PA•H2O
Experimenteel: Mitizodone Phosphate tablet 40mg
Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 40mg ,orally,once daily for 6 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks.
Geneesmiddel: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Andere namen:
  • HEC113995PA•H2O
Actieve vergelijker: Placebo
Placebo,tablet,orally,once daily for 10 weeks.
Geneesmiddel: Placebo-matching tablets
Placebo will be administered with food.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8
Tijdsspanne: baseline and week 8
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement.
baseline and week 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of subjects With a MADRS Response at Week 8
Tijdsspanne: baseline and week 8
Response is defined as a subject with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline.
baseline and week 8
Percentage of Participants in MADRS Remission at Week 8
Tijdsspanne: week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10.
week 8
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1、week 2 、week 4、week 6.
Tijdsspanne: baseline 、 week 1、week 2 、week 4 and week 6.
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement.
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.
Tijdsspanne: baseline、week 1、week 2 、week 4、week 6 and week 8.
The Clinical Global Impression-Severity of illness scale assesses the subject's Severity as assessed by the clinician at the moment on a 8-point scale: 0, not assessed ; 1, normal，not at all ill ; 2, borderline mentally ill ; 3, mildly ill ; 4, moderately ill ; 5 , markedly ill ; 6, severely ill；7，among the most extremely ill patients.
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
Tijdsspanne: week 1、week 2 、week 4、week 6 and week 8.
The Clinical Global Impression- Improvement scale assesses the subject's improvement (or worsening) as assessed by the clinician relative to Baseline on a 8-point scale: 0, not assessed ;1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
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.
Tijdsspanne: baseline、week 1、week 2 、week 4、week 6 and week 8.
the HAM-A is a anxiety rating scale consisting of 14 items, each rated 0 (none) to 4 (very severe). The 14 items represent the core symptoms of anxiety illness. The overall score ranges from 0 (symptoms absent) to 56 (severe anxiety). A decrease in the total score or on individual items indicates improvement.
baseline、week 1、week 2 、week 4、week 6 and week 8.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sunshine Lake Pharma Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 december 2021

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

21 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2021

Eerst geplaatst (Werkelijk)

30 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HEC113995-P-5

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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