Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Hypidone Hydrochloride tablets; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anding Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing HuiLongGuan Hospital
    • Beijing, Beijing, China
      • Peking University Sixth Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou Hui'ai Hospital
  • Hebei
    • Baoding, Hebei, China
      • Hebei Mental Health Center
  • Henan
    • Xinxiang, Henan, China
      • Henan Psychiatric Hospital
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Mental Health Center
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Brain Hospital
    • Wuxi, Jiangsu, China
      • Wuxi mental health center
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Mental Hospital
  • Jilin
    • Siping, Jilin, China
      • Jilin Neuropsychiatric Hospital
  • Shandong
    • Jinan, Shandong, China
      • Shandong Mental Health Center
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Xi'an, Shanxi, China
      • Xi'an Mental Health Center
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University
    • Hangzhou, Zhejiang, China
      • The 7th People's Hospital of Hangzhou
    • Huzhou, Zhejiang, China
      • The Third People's Hospital of Huzhou
    • Ningbo, Zhejiang, China
      • Ningbo Kangning Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 10 mg of Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks	Drug: Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
EXPERIMENTAL: 20 mg of Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks	Drug: Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
EXPERIMENTAL: 40 mg of Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks	Drug: Hypidone Hydrochloride tablets; Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
PLACEBO_COMPARATOR: comparator; Placebo tablets is to be given orally, twice daily, for 6 weeks	Other: Placebo; Placebo tablets will be given orally, twice daily, for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	Change from baseline in MADRS scores，the *total* score ranges[0,60],higher values represent a worse outcome	Baseline,43 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale 17 items(HAMD17)	Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome	Baseline,43 days after treatment
Hamilton Anxiety Rating Scale (HAM-A)	Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome	Baseline,43 days after treatment
Clinical Global Impression of Severity Scale(CGI-S)	Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome	Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Clinical Global Impression of Improvement Scale(CGI-I)	the *total* score ranges[0,7],higher values represent a worse outcome	8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in Digit Symbol Substitution Test (DSST)		Baseline, 43 days after treatment
Change in Trail Making Test Parts A&B (TMT)		Baseline, 43 days after treatment

Collaborators and Investigators

• Sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2018
• Primary Completion (ACTUAL): December 18, 2019
• Study Completion (ACTUAL): December 23, 2019

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (ACTUAL): November 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: HYP202-CTP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No