Major Depressive DisorderPhase 1/2NCT03404466
To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD
A Phase 1/2 study testing Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Hypidone Hydrochloride tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2018to 17 Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai mental health center
Shanghai, Shanghai Municipality, 200030
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Hypidone Hydrochloride tablets
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypidone Hydrochloride tabletsDrug
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental group one | Experimental | 10 mg of Hypidone Hydrochloride tablets Receives: Drug: Hypidone Hydrochloride tablets |
| experimental group two | Experimental | 20 mg of Hypidone Hydrochloride tablets Receives: Drug: Hypidone Hydrochloride tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome
Measured: 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)
Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome
Measured: 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)
Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome
Measured: 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)
the *total* score ranges[0,7],higher values represent a worse outcome
Measured: 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Columbia-Suicide Severity Rating Scale (C-SSRS)
Safety index，no total score
Measured: Baseline,15 day after treatment,43 day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start24 Feb 2018
- Primary completion10 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Huahai Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huafang Li, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404466
- Sponsor's protocol ID
- HYP201-CTP
- Status last verified
- Oct 2020
- First submitted
- 12 Jan 2018
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03404466
- Acronym / sponsor ID
- HYP201-CTP
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zhejiang Huahai Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group one | Experimental | Drug: Hypidone Hydrochloride tablets10 mg of Hypidone Hydrochloride tablets |
| experimental group two | Experimental | Drug: Hypidone Hydrochloride tablets20 mg of Hypidone Hydrochloride tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypidone Hydrochloride tabletsHypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks | Drug | experimental group one, experimental group two |
Primary outcome
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
5 secondary outcomes
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 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 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 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
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline,15 day after treatment,43 day after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang Li, PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.