Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03739632
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Hypidone Hydrochloride tablets Other: Placebo Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Hamilton Depression Scale 17 items(HAMD17) [ Time Frame: Baseline,43 days after treatment ]
    Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome

  2. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline,43 days after treatment ]
    Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome

  3. Clinical Global Impression of Severity Scale(CGI-S) [ Time Frame: Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment ]
    Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome

  4. Clinical Global Impression of Improvement Scale(CGI-I) [ Time Frame: 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment ]
    the *total* score ranges[0,7],higher values represent a worse outcome

  5. Change in Digit Symbol Substitution Test (DSST) [ Time Frame: Baseline, 43 days after treatment ]
  6. Change in Trail Making Test Parts A&B (TMT) [ Time Frame: Baseline, 43 days after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739632


Contacts
Layout table for location contacts
Contact: Huafang Li, PhD 021-34289888 ext 3128 lhlh_5@163.com
Contact: Yifeng Shen, PhD 021-64387250 shenyifeng@yahoo.com

Locations
Layout table for location information
China, Shanghai
Shanghai mental health center Not yet recruiting
Shanghai, Shanghai, China, 200030
Contact: Hhuafang Li, PhD    021-34289888 ext 3128    lhlh_5@163.com   
Sponsors and Collaborators
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.

Layout table for additonal information
Responsible Party: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT03739632     History of Changes
Other Study ID Numbers: HYP202-CTP
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms