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Major Depressive DisorderPhase 2NCT03739632

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

A Phase 2 study testing Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 scores 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?
Yes, some participants may receive a placebo
How many people
240 participants
Where
19 sitesChina
Study dates
30 Nov 2018to 23 Dec 2019
Phase
Phase 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 or Inpatient, 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 forms

Who cannot join

  • Subjects accord with other mental disorders diagnosed by DSM-5
  • 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
  • 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
Show all 10Show fewer
  • Practicing 2 different treatment methods of antidepressants as recommended dose of full course (≥6 weeks)
  • 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
  • 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

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Hebei Mental Health Center

    Baoding, Hebei

  • Beijing Anding Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Huilongguan Hospital

    Beijing, Beijing Municipality

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality

  • Guangzhou Hui'ai Hospital

    Guangzhou, Guangdong

  • The 7th People's Hospital of Hangzhou

    Hangzhou, Zhejiang

  • the First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • The Third People's Hospital of Huzhou

    Huzhou, Zhejiang

  • Shandong Mental Health Center

    Jinan, Shandong

  • Jiangxi Mental Hospital

    Nanchang, Jiangxi

  • Nanjing Brain Hospital

    Nanjing, Jiangsu

  • Ningbo Kangning Hospital

    Ningbo, Zhejiang

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

  • Jilin Neuropsychiatric Hospital

    Siping, Jilin

  • Wuhan Mental Health Center

    Wuhan, Hubei

  • Wuxi Mental Health Center

    Wuxi, Jiangsu

  • Xi'an Mental Health Center

    Xi’an, Shanxi

  • Henan Psychiatric Hospital

    Xinxiang, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Hypidone Hydrochloride tablets, Placebo
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 will be given orally, twice daily, for 6 weeks

  • PlaceboOther

    Placebo tablets will be given orally, twice daily, for 6 weeks

Study groups in NCT03739632
Study groupRoleWhat they receive
10 mg of Hypidone Hydrochloride tabletsExperimentalHypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks
Receives: Drug: Hypidone Hydrochloride tablets
20 mg of Hypidone Hydrochloride tabletsExperimentalHypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks
Receives: Drug: Hypidone Hydrochloride tablets
40 mg of Hypidone Hydrochloride tabletsExperimentalHypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks
Receives: Drug: Hypidone Hydrochloride tablets
comparatorPlacebo comparatorPlacebo tablets is to be given orally, twice daily, for 6 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Baseline,43 days after treatment

Secondary outcomes (6)

  1. 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,43 days after treatment

  2. 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,43 days after treatment

  3. 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

  4. 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

  5. Change in Digit Symbol Substitution Test (DSST)

    Measured: Baseline, 43 days after treatment

  6. Change in Trail Making Test Parts A&B (TMT)

    Measured: Baseline, 43 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start30 Nov 2018
  3. Primary completion18 Dec 2019
  4. Study completion23 Dec 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739632
Sponsor's protocol ID
HYP202-CTP
Status last verified
Oct 2020
First submitted
9 Nov 2018
Last updated
30 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypidone Hydrochloride tablets in people with Major Depressive Disorder, run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 19 sites 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 19 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline,43 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03739632.

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.

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