Major Depressive DisorderPhase 1NCT03785652

Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

A Phase 1 study testing LY03005 extended-release tablets 40 mg, LY03005 extended-release tablets 80 mg group and LY03005 extended-release tablets 120 mg group in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site 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

This study was a multicenter, randomized, double-blind, placebo, parallel-controlled, dose-finding Phase II clinical trial to find the optimal dose of LY03005 Extended-release Tablets for the treatment of MDD and to evaluate the preliminary efficacy and safety, providing a basis for the design of phase III clinical… 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?: LY03005 extended-release tablets 40 mg, LY03005 extended-release tablets 80 mg group and LY03005 extended-release tablets 120 mg group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 1 siteChina
Study dates: 9 Oct 2015to 31 Oct 2015
Phase: Phase 1
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

Male and female aged 18 to 65 years subjects from outpatient or inpatient;
Subjects who meet the diagnostic criteria for MDD in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) with either single or recurrent episodes (296.2/296.3) without psychotic characteristics;
Total scores of 17-item Hamilton Depression Scale (HAM-D17) ≥ 20 points at screening and baseline visits；
First item (depressive mood) score of HAM-D17 scale ≥ 2 points at screening and baseline visits;
Clinical global impression scale-disease severity (CGI-S) score ≥ 4 points at screening and baseline visits;
At screening and baseline, women of childbearing age (e.g., women who have not undergone surgical sterilization or less than one year after menopause) have a urine negative pregnancy test result. Male and female subjects of childbearing age agree to take effective contraceptive measures during the entire study period and at least 28 days after the last dose of investigatory drug;
Subjects voluntarily participate in the trial by signing the informed consent form and are able to follow the schedule in the protocol for visits, treatment, laboratory tests and other research procedures.

Who cannot join

Allergic or known to be allergic to venlafaxine and desvenlafaxine;
MDD subjects who were not responsive to the previous venlafaxine treatment with sufficient amount and duration or TRD, to at least two different mechanisms of action antidepressants with adequate amount and duration in the past;
Total scores of HAM-D17 scale at baseline was decreased ≥25% compared with the one at screening;
There is a clear suicide attempt or behavior and score of the 3rd item (suicidal thought) in HAM-D17 total scale ≥ 3 points;
Gestational and lactating women or the subjects of childbearing age who do not take effective contraception or who do not agree to continue using contraception within 28 days of the last dose;
Suppressed subjects who also meet other diagnoses on the DSM-IV-TR axis I or received the treatment for such diagnoses (including current or previous diagnosis of anorexia nervosa or bulimia nervosa), or was diagnosed as dysthymia in the past 2 years;

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MDD secondary to other mental illnesses or physical illnesses;
Those with a history of seizures (except for convulsions caused by febrile seizures in children);
Those receiving electroconvulsive therapy (ECT) within 3 months prior to screening or according to the investigator's judgment that ECT is currently required; Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months prior to screening；Those who have received transcranial magnetic stimulation (TMS) within 3 months prior to screening, or have received light therapy within 2 weeks prior to screening;
Subjects who have regularly taken anti-depressants within 2 weeks prior to screening, and have stopped the anti-depressants less than 2 weeks or psychotropic drugs for less than 7 half-lives prior to study randomization (monoamine oxidase inhibitor for at least 2 weeks, fluoxetine for at least 1 month);
Subjects who have seriously unstable cardiovascular, liver, kidneys, blood, endocrine and other physical diseases or a medical history;
Hypertensive patients with poor blood pressure control (SBP≥140 mmHg or DBP≥90 mmHg at screening and baseline);
There is a history of gastrointestinal disease known to interfere with drug absorption or excretion or a history of surgery known to interfere with drug absorption or excretion;
A history of increased intra-ocular pressure or narrow-angle glaucoma;
Clinically significant abnormalities based in investigators judgment during screening (for example, such as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than upper limit of normal range; creatinine (Cr) is higher than the upper limit of normal ranges and clinical significant abnormal thyroid function);
Electrocardiogram (ECG) abnormalities are clinically significant at screening and the investigators believe that it is inappropriate for the subjects to be enrolled, such as QTc interval ≥450 ms for male and QTc interval ≥460 ms for female;
Those who have participated in other clinical trials within 3 months prior to screening;
Those with serious acute or chronic diseases, mental illnesses or clinically significant abnormalities in laboratory tests, of which investigators believe that the subjects are not suitable for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Approval Letter of Ethics Committee of The Sixth Hospital of Peking University
Haidian District,, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

Read the detailed description

The study consisted of two periods: a screening and washout period of 2 weeks (recommended 8 days) and a double-blind treatment period (6 weeks). The first period is the screening and washing period, the longest is 14 days and the shortest is 8 days (recommended 8 days), in which the enrolled MDD subjects will start a one-week placebo wash period and receive prescribed a placebo, 2 pills once a day for 7 consecutive days. The second period was a double-blind treatment period of 6 weeks. After the placebo washout period, 260 enrolled subjects were randomized into one of 5 study groups in the 1:1:1:1:1 ratio, 4 LY03005 Extended-release Tablets treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, 4 pills once a day and followed up at the end of 1, 2, 4 and 6 weeks.

Effectiveness of the investigational drug was evaluated using 17 Hamilton Depression Scale (HAM-D17), Montgomery-Asberg Depression Scale (MADRS), Hamilton Anxiety Scale (HAMA), Clinical Global Impression Scale (CGI) and Visual Analog Scale-Pain intensity (VAS-PI) scores. Safety of the treatment was evaluated by adverse events, vital signs, laboratory measurements (blood routine, urine routine, blood biochemistry and serology), 12-lead ECG, physical examination, the Arizona Sexual Experience Scale (ASEX) and the Columbia-Suicide Severity Rating Scale (C-SSRS) scores.

Conditions: Major Depressive Disorder
Being tested: LY03005 extended-release tablets 40 mg, LY03005 extended-release tablets 80 mg group, LY03005 extended-release tablets 120 mg group, LY03005 extended-release tablets 160 mg group, Placebo group
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.

LY03005 extended-release tablets 40 mgDrug
LY03005 extended-release tablets 40 mg group :40mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfas
LY03005 extended-release tablets 80 mg groupDrug
LY03005 extended-release tablets 80 mg group :
80mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
LY03005 extended-release tablets 120 mg groupDrug
LY03005 extended-release tablets 120 mg group :
120mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
LY03005 extended-release tablets 160 mg groupDrug
LY03005 extended-release tablets 160 mg group :
160mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
Placebo groupDrug
Placebo group :
Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast

Study groups in NCT03785652
Study group	Role	What they receive
LY03005 extended-release tablets	Experimental	LY03005 extended-release tablets at 4 doses 40 mg, 80mg, 120mg or 160mg Receives: Drug: LY03005 extended-release tablets 40 mg; Drug: LY03005 extended-release tablets 80 mg group; Drug: LY03005 extended-release tablets 120 mg group; Drug: LY03005 extended-release tablets 160 mg group
Placebo	Placebo comparator	Placebo tablet Receives: Drug: Placebo group

What is being measured

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

Hamilton Depression Scale
Changes from baseline in the total score of 17 items of Hamilton Depression Scale (HAM-D17) at the end of treatment
Measured: 8 weeks

Secondary outcomes (2)

Montgomery- Åsberg Depression Rating Scale(MADRS)
Changes from baseline in the 10-items Montgomery- Åsberg Depression Rating Scale(MADRS) total scores at the end of treatment;
Measured: 8 Weeks
Clinical Global Impression Scale - improvement (CGI-I)
Changes in the Clinical Global Impression Scale - improvement (CGI-I) scores at the end of treatment
Measured: 8 Weeks

Timeline

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

9 Oct 201531 Oct 2015

First posted24 Dec 2018
Study start9 Oct 2015
Primary completion31 Oct 2015
Study completion31 Oct 2015

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.
More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03785652
Sponsor's protocol ID: LY03005-CHN-204
Status last verified: Dec 2018
First submitted: 17 Dec 2018
Last updated: 24 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT03785652
Acronym / sponsor ID: LY03005-CHN-204
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
Collaborators: Shandong Luye Pharmaceutical Co., Ltd.
Study start: 9 Oct 2015 (actual)
Primary completion: 31 Oct 2015 (actual)
Study completion: 31 Oct 2015 (actual)
First posted: 24 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY03005 extended-release tablets	Experimental	Drug: LY03005 extended-release tablets 40 mg, Drug: LY03005 extended-release tablets 80 mg group, Drug: LY03005 extended-release tablets 120 mg group, Drug: LY03005 extended-release tablets 160 mg groupLY03005 extended-release tablets at 4 doses 40 mg, 80mg, 120mg or 160mg
Placebo	Placebo comparator	Drug: Placebo groupPlacebo tablet

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female aged 18 to 65 years subjects from outpatient or inpatient;
Subjects who meet the diagnostic criteria for MDD in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) with either single or recurrent episodes (296.2/296.3) without psychotic characteristics;
Total scores of 17-item Hamilton Depression Scale (HAM-D17) ≥ 20 points at screening and baseline visits；
First item (depressive mood) score of HAM-D17 scale ≥ 2 points at screening and baseline visits;
Clinical global impression scale-disease severity (CGI-S) score ≥ 4 points at screening and baseline visits;

Key exclusion criteria (18 listed)

Allergic or known to be allergic to venlafaxine and desvenlafaxine;
MDD subjects who were not responsive to the previous venlafaxine treatment with sufficient amount and duration or TRD, to at least two different mechanisms of action antidepressants with adequate amount and duration in the past;
Total scores of HAM-D17 scale at baseline was decreased ≥25% compared with the one at screening;
There is a clear suicide attempt or behavior and score of the 3rd item (suicidal thought) in HAM-D17 total scale ≥ 3 points;
Gestational and lactating women or the subjects of childbearing age who do not take effective contraception or who do not agree to continue using contraception within 28 days of the last dose;

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
LY03005 extended-release tablets 40 mgLY03005 extended-release tablets 40 mg group :40mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfas	Drug	LY03005 extended-release tablets
LY03005 extended-release tablets 80 mg groupLY03005 extended-release tablets 80 mg group : 80mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast	Drug	LY03005 extended-release tablets
LY03005 extended-release tablets 120 mg groupLY03005 extended-release tablets 120 mg group : 120mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast	Drug	LY03005 extended-release tablets
LY03005 extended-release tablets 160 mg groupLY03005 extended-release tablets 160 mg group : 160mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast	Drug	LY03005 extended-release tablets
Placebo groupPlacebo group : Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast	Drug	Placebo

Primary outcome

Hamilton Depression Scale
Time frame: 8 weeks
Changes from baseline in the total score of 17 items of Hamilton Depression Scale (HAM-D17) at the end of treatment

2 secondary outcomes

Montgomery- Åsberg Depression Rating Scale(MADRS)
Time frame: 8 Weeks
Clinical Global Impression Scale - improvement (CGI-I)
Time frame: 8 Weeks

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 24 Dec 2018.
Individual participant dataSharing planned: No

Related trials for Major Depressive Disorder

Recruiting
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Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
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RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
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RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
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Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 18 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 24 Dec 2018. 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. 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 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.

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?

Hamilton Depression Scale (time frame: 8 weeks). 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 NCT03785652.

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 24 Dec 2018.