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

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ClinicalTrials.gov Identifier: NCT03404466
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : February 1, 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 score from baseline to week 6.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Hypidone Hydrochloride tablets Phase 1 Phase 2

Detailed Description:
A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter,Randomized,Open-label,Parallel-group,and Adaptive Design Clinical Study to Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With Major Depressive Disorder
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group one
10 mg of Hypidone Hydrochloride tablets
Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks

Experimental: experimental group two
20 mg of Hypidone Hydrochloride tablets
Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks




Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment ]
    Change from baseline in MADRS scores,the *total* score ranges[0,60],higher values represent a worse outcome


Secondary Outcome Measures :
  1. Change in Hamilton Depression Scale 17 items(HAMD17) [ Time Frame: Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment ]
    Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome

  2. Change in Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment ]
    Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome

  3. Change in 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. Change in 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. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline,15 day after treatment,43 day after treatment ]
    Safety index,no total score



Information from the National Library of Medicine

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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, 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

Exclusion Criteria:

  1. Patients accord with other mental disorders diagnosed by DSM-5
  2. Attempts to suicide, or who presently have a high risk of suicide, or 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
  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, 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): NCT03404466


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

Locations
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China, Shanghai
Shanghai mental health center 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.

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Responsible Party: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT03404466     History of Changes
Other Study ID Numbers: HYP201-CTP
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms