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

NCT03785652 | Completed Phase 1

• 1 other identifier: LY03005-CHN-204
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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 trials and the determination of dosing regimens.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale

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

  8 weeks

Secondary Outcomes (2)

• Montgomery- Åsberg Depression Rating Scale(MADRS)

  8 Weeks

• Clinical Global Impression Scale - improvement (CGI-I)

  8 Weeks

Study Arms (2)

LY03005 extended-release tablets

EXPERIMENTAL

LY03005 extended-release tablets at 4 doses 40 mg, 80mg, 120mg or 160mg

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

Drug: Placebo group

Interventions

LY03005 extended-release tablets 40 mg DRUG

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

LY03005 extended-release tablets 80 mg group DRUG

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

LY03005 extended-release tablets 120 mg group DRUG

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

LY03005 extended-release tablets 160 mg group DRUG

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

LY03005 extended-release tablets

Placebo group DRUG

Placebo group : Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shandong Luye Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Approval Letter of Ethics Committee of The Sixth Hospital of Peking University

Haidian District,, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: October 9, 2015
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)