To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD

NCT03404466 | Completed Phase 1

• 1 other identifier: HYP201-CTP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  Change from baseline in MADRS scores，the \*total\* score ranges\[0,60\],higher values represent a worse outcome

  Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

Secondary Outcomes (5)

• Change in Hamilton Depression Scale 17 items(HAMD17)

  Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

• Change in Hamilton Anxiety Rating Scale (HAM-A)

  Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment

• Change in Clinical Global Impression of Severity Scale(CGI-S)

  Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

• Change in Clinical Global Impression of Improvement Scale(CGI-I)

  8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline,15 day after treatment,43 day after treatment

Study Arms (2)

experimental group one

EXPERIMENTAL

10 mg of Hypidone Hydrochloride tablets

Drug: Hypidone Hydrochloride tablets

experimental group two

EXPERIMENTAL

20 mg of Hypidone Hydrochloride tablets

Drug: Hypidone Hydrochloride tablets

Interventions

Hypidone Hydrochloride tablets DRUG

Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks

experimental group one; experimental group two

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, 18-65 years old, Male or female
• 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)
• Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
• The first item of MADRS in both Screening and Baseline ≥ 3
• CGI-S in both Screening and Baseline ≥ 4
• Able to provide written informed consent

You may not qualify if:

• Patients accord with other mental disorders diagnosed by DSM-5
• Attempts to suicide, or who presently have a high risk of suicide, or The tenth item (Suicidal ideation) of C-SSRS ≥ 3
• Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
• Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
• Subjects with clinically significant ECG abnormal(Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec )
• Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
• practicing 2 different treatment methods of antidepressants as recommended dose of full course
• 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
• Subjects with a history of true allergic response to more than 1 class of medications
• Subjects who participated in a clinical trial within the last 30 days.

Sponsors & Collaborators

• Zhejiang Huahai Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai mental health center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang Li, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: February 24, 2018
• Primary Completion: July 10, 2018
• Study Completion: July 17, 2018
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

CN (1)