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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984512
• Other study ID #: HEC113995-P-5
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2021
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: gang wang, Ph.D
• Phone: 86-010-58303236
• Email: gangwangdoc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 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
Secondary	Percentage of subjects With a MADRS Response at 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
Secondary	Percentage of Participants in MADRS Remission at Week 8	Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score =10.	week 8
Secondary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1?week 2 ?week 4?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.
Secondary	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.	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.
Secondary	Clinical Global Impression - Improvement (CGI-I) Score at week 1?week 2 ?week 4?week 6?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.
Secondary	Change From Baseline in the hamilton anxiety rating scale (HAM-A)Total Score at week 1?week 2 ?week 4?week 6?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.