Clinical trial NCT03404466: To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD
Official title: A Multicenter,Randomized,Open-label,Parallel-group,and Adaptive Design Clinical Study to Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total score from baseline to week 6.

Detailed description: A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments The subjects will accept the drug treatment twice daily orally for 6 weeks, During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment ,43±2 days after treatment to evaluate the safety and efficacy of the drug.

Eligibility criteria: Inclusion Criteria:

1. Outpatient, 18-65 years old, Male or female
2. Current major depressive disorder diagnosed by DSM-5,single episode(296.21, 296.22, 296.23),or recurrent episode(296.31, 296.32, 296.33)
3. Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
4. The first item of MADRS in both Screening and Baseline ≥ 3
5. CGI-S in both Screening and Baseline ≥ 4
6. Able to provide written informed consent

Exclusion Criteria:

1. Patients accord with other mental disorders diagnosed by DSM-5
2. Attempts to suicide, or who presently have a high risk of suicide, or The tenth item (Suicidal ideation) of C-SSRS ≥ 3
3. Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
4. Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
5. Subjects with clinically significant ECG abnormal(Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec )
6. Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
7. practicing 2 different treatment methods of antidepressants as recommended dose of full course
8. Subjects who have had a Vagus Nerve Stimulation(VNS) device implanted or who have received Modified Electric Convulsive Therapy(MECT) or Transcranial Magnetic Stimulation (TMS) within 3 months of Screening, received light treatment, laser treatment, acupuncture and other Chinese medicine treatment, biofeedback treatment within 2 weeks of Screening
9. Subjects with a history of true allergic response to more than 1 class of medications
10. Subjects who participated in a clinical trial within the last 30 days.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Secondary outcomes:
measure: Change in Hamilton Depression Scale 17 items(HAMD17)
timeFrame: Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
measure: Change in Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment
measure: Change in Clinical Global Impression of Severity Scale(CGI-S)
timeFrame: Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
measure: Change in Clinical Global Impression of Improvement Scale(CGI-I)
timeFrame: 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline,15 day after treatment,43 day after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai mental health center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: