Clinical trial NCT03739632: Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 240
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 scores from baseline to week 6.

Detailed description: A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment.

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 or Inpatient, 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 forms

Exclusion Criteria:

1. Subjects accord with other mental disorders diagnosed by DSM-5
2. Subjects who attempted to suicide, or who presently have a high risk of suicide, or with 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 (≥6 weeks)
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, or who 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: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline,43 days after treatment
Secondary outcomes:
measure: Hamilton Depression Scale 17 items(HAMD17)
timeFrame: Baseline,43 days after treatment
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline,43 days after treatment
measure: 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: 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: Change in Digit Symbol Substitution Test (DSST)
timeFrame: Baseline, 43 days after treatment
measure: Change in Trail Making Test Parts A&B (TMT)
timeFrame: Baseline, 43 days after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Hui'ai Hospital
state: Guangdong
city: Baoding
country: China
facility: Hebei Mental Health Center
state: Hebei
city: Xinxiang
country: China
facility: Henan Psychiatric Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Mental Hospital
state: Jiangxi
city: Siping
country: China
facility: Jilin Neuropsychiatric Hospital
state: Jilin
city: Jinan
country: China
facility: Shandong Mental Health Center
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
city: Hangzhou
country: China
facility: The 7th People's Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Huzhou
country: China
facility: The Third People's Hospital of Huzhou
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Kangning Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: