Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
NCT ID: NCT03739632
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2018-11-30
2019-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks
Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
20 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks
Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
40 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks
Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
comparator
Placebo tablets is to be given orally, twice daily, for 6 weeks
Placebo
Placebo tablets will be given orally, twice daily, for 6 weeks
Interventions
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Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
Placebo
Placebo tablets will be given orally, twice daily, for 6 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Huahai Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Huafang Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Guangzhou Hui'ai Hospital
Guangzhou, Guangdong, China
Hebei Mental Health Center
Baoding, Hebei, China
Henan Psychiatric Hospital
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Mental Health Center
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Jiangxi Mental Hospital
Nanchang, Jiangxi, China
Jilin Neuropsychiatric Hospital
Siping, Jilin, China
Shandong Mental Health Center
Jinan, Shandong, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Xi'an Mental Health Center
Xi’an, Shanxi, China
The 7th People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
The Third People's Hospital of Huzhou
Huzhou, Zhejiang, China
Ningbo Kangning Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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HYP202-CTP
Identifier Type: -
Identifier Source: org_study_id