The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mitizodone Phosphate tablet 10mg Mitizodone Phosphate tablet 10mg ,orally,once daily for 8 weeks, then placebo,orally,once daily for 2 weeks. |
Drug: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Other Names:
|
| Experimental: 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. |
Drug: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Other Names:
|
| Experimental: 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. |
Drug: Mitizodone Phosphate tablets
Mitizodone Phosphate tablets will be administered with food.
Other Names:
|
| Active Comparator: Placebo Placebo,tablet,orally,once daily for 10 weeks. |
Drug: Placebo-matching tablets
Placebo will be administered with food.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8 [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.
Secondary Outcome Measures
- Percentage of subjects With a MADRS Response at Week 8 [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.
- Percentage of Participants in MADRS Remission at Week 8 [week 8]
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10.
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 1、week 2 、week 4、week 6. [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.
- 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. [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.
- Clinical Global Impression - Improvement (CGI-I) Score at week 1、week 2 、week 4、week 6、Week 8 [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.
- Change From Baseline in the hamilton anxiety rating scale （HAM-A）Total Score at week 1、week 2 、week 4、week 6、week 8. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
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3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
Exclusion Criteria:
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1.has major depressive disorder with psychotic features according to the DSM-5.
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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.
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3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).
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- has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.
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- Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).
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- Current or history of angle-closure glaucoma.
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- 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 .
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8.has taken fluoxetine within 4 weeks prior to initial dosing.
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- has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.
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10.has psychotherap at Screening and/or Baseline Visits.
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11.has had physiotherapy within 3 months prior to initial dosing.
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12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
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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.
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14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.
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15.Has a history of severe allergies.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunshine Lake Pharma Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HEC113995-P-5