Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression

NCT ID: NCT05018013

Last Updated: 2021-11-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-21
• Study Completion Date: 2022-12-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.

Detailed Description

In this study, a randomized, double-blind, duloxetine hydrochloride enteric coated capsule positive and placebo-controlled multicenter study was used to evaluate the efficacy and safety of different doses of amxetine hydrochloride enteric coated tablets in the treatment of depression.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ammoxetine group-cohort 1

The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine.

Group Type: EXPERIMENTAL

Ammoxetine hydrochloride enteric-coated tablets

Intervention Type: DRUG

Ammoxetine hydrochloride enteric-coated tablets

Placebo to Duloxetine

Intervention Type: DRUG

Placebo to Duloxetine

Ammoxetine group-cohort 2

The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine.

Group Type: EXPERIMENTAL

Ammoxetine hydrochloride enteric-coated tablets

Intervention Type: DRUG

Ammoxetine hydrochloride enteric-coated tablets

Placebo to Duloxetine

Intervention Type: DRUG

Placebo to Duloxetine

Ammoxetine group-cohort 3

The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine.

Group Type: EXPERIMENTAL

Ammoxetine hydrochloride enteric-coated tablets

Intervention Type: DRUG

Ammoxetine hydrochloride enteric-coated tablets

Placebo to Duloxetine

Intervention Type: DRUG

Placebo to Duloxetine

Ammoxetine group-cohort 4

The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine.

Group Type: EXPERIMENTAL

Ammoxetine hydrochloride enteric-coated tablets

Intervention Type: DRUG

Ammoxetine hydrochloride enteric-coated tablets

Placebo to Duloxetine

Intervention Type: DRUG

Placebo to Duloxetine

Duloxetine group

The eligible subjects will receive duloxetine hydrochloride enteric-coated capsules plus placebo to Ammoxetine.

Group Type: ACTIVE_COMPARATOR

Duloxetine hydrochloride enteric-coated capsules

Intervention Type: DRUG

Duloxetine hydrochloride enteric-coated capsules

Placebo to Ammoxetine

Intervention Type: DRUG

Placebo to Ammoxetine

Placebo group

The eligible subjects will receive placebo to Ammoxetine and placebo to Duloxetine.

Group Type: PLACEBO_COMPARATOR

Placebo to Ammoxetine

Intervention Type: DRUG

Placebo to Ammoxetine

Placebo to Duloxetine

Intervention Type: DRUG

Placebo to Duloxetine

Interventions

Ammoxetine hydrochloride enteric-coated tablets

Ammoxetine hydrochloride enteric-coated tablets

Intervention Type: DRUG

Duloxetine hydrochloride enteric-coated capsules

Duloxetine hydrochloride enteric-coated capsules

Intervention Type: DRUG

Placebo to Ammoxetine

Placebo to Ammoxetine

Intervention Type: DRUG

Placebo to Duloxetine

Placebo to Duloxetine

Intervention Type: DRUG

Other Intervention Names

Ammoxetine; Duloxetine; Placebo; Placebo

Eligibility Criteria

Inclusion Criteria

• 1. Subjects aged 18 and 65 years (inclusive), no gender limitation;
• 2. Subject has recurrent Major Depressive Disorder (MDD) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5, 5th Edition), single episode or recurrent episodes (DSM-IV-TR criteria, classification code 296.2/296.3), without psychotic symptoms;
• 3. Subjects with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 and subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline;
• 4. For male or female with fertility: must agree to use effective contraceptive method during the study and within 1 month after the end of the trial;
• 5. Be able to read and understand the content of the informed consent and voluntarily sign the informed consent.

Exclusion Criteria

• 1. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
• 2. Subjects meet DSM-5 diagnostic criteria for other mental disorders (schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, etc.);
• 3. Subjects are diagnosed as DSM-5 drug use disorder;
• 4. Refractory depression (subjects who had previously used two different mechanisms of antidepressants and failed after receiving adequate treatment (at least 8 weeks);
• 5. Organic mental disorders, such as depression caused by hypothyroidism;
• 6. Depression caused by psychoactive substances or non-addictive substances;
• 7. Subjects with other diseases or other types of mental disorders with depressive symptoms;
• 8. Subjects assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) and those judged by the investigator to be at risk for suicide, or to have engaged in suicidal behaviour within 6 months prior to screening;
• 9. Allergic constitution (e.g. allergic to two or more drugs or to serotonin norepinephrine reuptake inhibitors (SNRIs));
• 10.Previous history of malignant tumor;
• 11.Previous history of elevated intraocular pressure or narrow angle glaucoma;
• 12.Subjects suffered from other serious physical diseases, such as uncontrolled hypertension or unstable cardiovascular disease, serious liver disease, kidney disease, blood disease, endocrine disease, neurological disease, etc;
• 13.Subjects with diseases that interfere with the absorption of oral medications, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc;
• 14.Subjects who have used drugs or foods that alter the activity of liver enzymes (CYP2C19 and CYP3A4) such as dexamethasone, rifampicin, omeprazole, grapefruit, etc., within 4 weeks prior to screening;
• 15.12-lead ECG system showed degree II or III atrioventricular block, long QT syndrome or QTc > 450 ms (male) / 470 ms (female) at screening;
• 16.Subjects discontinued use of a combination of drugs that prolong the QT interval prior to randomization, or drugs that can cause prolongation of the QT and may induce TdP for less than 5 half-lives of the drugs;
• 17.In screening period, subjects with ALT or AST 1.5 times higher than the upper limit of laboratory normal value; creatinine 1.1 times higher than the upper limit of normal value; and abnormalities in 2 or more of the 5 indicators of thyroid function (TSH, FT3, FT4, TT3 or TT4 0.9 times below the lower limit of normal value or 1.1 times above the upper limit of normal value);
• 18.Subjects have used monoamine oxidase inhibitors within 2 weeks before randomization;
• 19.Subjects discontinuing antipsychotics, antidepressants or mood stabilizers for less than 5 half-lives of the drug before randomization;
• 20.Subjects who are using long half-life drugs (such as fluoxetine, long-acting antipsychotics, etc.);
• 21.Subjects who have received electroconvulsive therapy (ECT), systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavior therapy, etc.), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), phototherapy, etc. within 3 months before screening, or subjects who, in the judgment of the investigator, are currently in need of such treatment;
• 22.Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study;
• 23.Alcohol or drug dependence within 3 months before screening;
• 24.Subjects who have participated in other clinical trials within 3 months before screening and are taking the test drug;
• 25.Subjects who, in the opinion of the investigator, have any other condition that makes them unsuitable for participation in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huang Yanli, MD

Role: STUDY_DIRECTOR

CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd

Li Huafang, Ph.D

Role: STUDY_CHAIR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yang, MA

Role: CONTACT

Phone: +86-13321898532

Email: lcliyang@mail.ecspc.com

Facility Contacts

Li Huafang, Ph.D

Role: primary

Other Identifiers

HA1406-CSP-003

Identifier Type: -

Identifier Source: org_study_id