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

NCT05762458 | Unknown Phase 2 DMC

• 1 other identifier: HA1406-005
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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)

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)

  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.

  Baseline and week 8

Secondary Outcomes (9)

• Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6, 8

  Baseline, week 1, 2, 4 ,6 and 8

• Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6, 8

  Baseline, week 1, 2, 4 ,6 and 8

• Change from baseline in CGI-S score at week 1, 2, 4, 6, 8

  Baseline, week 1, 2, 4, 6 and 8

• Change from baseline in MADRS score at week 1, 2, 4, 6

  baseline, week 1, 2 and 4, 6

• CGI-I scores at the end of 8 weeks of treatment at week 1, 2, 4, 6, 8

  Baseline, week 1, 2, 4, 6 and 8

Study Arms (3)

Ammoxetine group-cohort 1

EXPERIMENTAL

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

Drug: Ammoxetine; Drug: Placebo

Ammoxetine group-cohort 2

EXPERIMENTAL

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

Drug: Ammoxetine; Drug: Placebo

Placebo group

PLACEBO COMPARATOR

The eligible subjects will receive placebo to Ammoxetine.

Drug: Placebo

Interventions

Ammoxetine DRUG

Ammoxetine hydrochloride enteric-coated tablets

Ammoxetine group-cohort 1; Ammoxetine group-cohort 2

Placebo DRUG

placebo to Ammoxetine.

Ammoxetine group-cohort 1; Ammoxetine group-cohort 2; 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 at screening and baseline;
• Subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline;
• A score of ≥2 on the first item (depressed mood) of the HAMD-17 scale at the screening and baseline;
• 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 behavior 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, etc., within 4 weeks prior to randomization;
• lead ECG system showed degree Ⅱ or Ш atrioventricular block, long QT syndrome or QTc \> 450 ms (male) / 460 ms (female) at screening;

Sponsors & Collaborators

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

Related Publications (1)

• He S, Chen JX, Yu X, Lin H, Wang Z, Li X, Zhou Y, Liu YS, Zhang H, Wang J, An C, Liu H, Li C, Ni S, Li H. Efficacy and Safety of Ammoxetine in Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532650. doi: 10.1001/jamanetworkopen.2025.32650.

  PMID: 40982284 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ammoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Zhao Qian

CONTACT

+86-15893878757; zhaoq@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: March 9, 2023
• Study Start: February 28, 2023
• Primary Completion: May 15, 2024
• Study Completion: October 15, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share