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

NCT05018013 | Unknown Phase 2

• 1 other identifier: HA1406-CSP-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 6)

  The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement. Change = (Week 6 post-dose score - baseline week 0 score). at the end of treatment (week 6)

  Baseline and week 6

Secondary Outcomes (6)

• Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6

  Baseline, week 1, 2, 4 and 6

• Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6

  Baseline, week 1, 2, 4 and 6

• Change from baseline in CGI-S score at week 1, 2, 4, 6,7

  Baseline, week 1, 2, 4, 6 and 7

• The percentage of subjects with a MARDS score reduction ≥ 25%

  Week 1 and 2

• Incidence of adverse events (AE)

  Throughout the study period,an average of 18 months

Study Arms (6)

Duloxetine group

ACTIVE COMPARATOR

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

Drug: Duloxetine hydrochloride enteric-coated capsules; Drug: Placebo to Ammoxetine

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo to Ammoxetine; Drug: Placebo to Duloxetine

Ammoxetine group-cohort 1

EXPERIMENTAL

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

Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine

Ammoxetine group-cohort 2

EXPERIMENTAL

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

Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine

Ammoxetine group-cohort 3

EXPERIMENTAL

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

Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine

Ammoxetine group-cohort 4

EXPERIMENTAL

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

Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine

Interventions

Ammoxetine hydrochloride enteric-coated tablets DRUG

Ammoxetine hydrochloride enteric-coated tablets

Also known as: Ammoxetine

Ammoxetine group-cohort 1; Ammoxetine group-cohort 2; Ammoxetine group-cohort 3; Ammoxetine group-cohort 4

Duloxetine hydrochloride enteric-coated capsules DRUG

Duloxetine hydrochloride enteric-coated capsules

Also known as: Duloxetine

Duloxetine group

Placebo to Ammoxetine DRUG

Placebo to Ammoxetine

Also known as: Placebo

Duloxetine group; Placebo group

Placebo to Duloxetine DRUG

Placebo to Duloxetine

Also known as: Placebo

Ammoxetine group-cohort 1; Ammoxetine group-cohort 2; Ammoxetine group-cohort 3; Ammoxetine group-cohort 4; Placebo group

Eligibility Criteria

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

You may qualify if:

• \. Subjects aged 18 and 65 years (inclusive), no gender limitation;
• \. 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;
• \. 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;
• \. 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;
• \. Be able to read and understand the content of the informed consent and voluntarily sign the informed consent.

You may not qualify if:

• \. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
• \. 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.);
• \. Subjects are diagnosed as DSM-5 drug use disorder;
• \. Refractory depression (subjects who had previously used two different mechanisms of antidepressants and failed after receiving adequate treatment (at least 8 weeks);
• \. Organic mental disorders, such as depression caused by hypothyroidism;
• \. Depression caused by psychoactive substances or non-addictive substances;
• \. Subjects with other diseases or other types of mental disorders with depressive symptoms;
• \. 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;
• \. Allergic constitution (e.g. allergic to two or more drugs or to serotonin norepinephrine reuptake inhibitors (SNRIs));
• Previous history of malignant tumor;
• Previous history of elevated intraocular pressure or narrow angle glaucoma;
• 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;
• Subjects with diseases that interfere with the absorption of oral medications, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc;
• 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;
• lead ECG system showed degree II or III atrioventricular block, long QT syndrome or QTc \> 450 ms (male) / 470 ms (female) at screening;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ammoxetine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huang Yanli, MD

  CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd

  STUDY DIRECTOR

• Li Huafang, Ph.D

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Li Yang, MA

CONTACT

+86-13321898532; lcliyang@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 24, 2021
• Study Start: August 21, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 30, 2022
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)