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

NCT06827431 | Not Yet Recruiting Phase 3

• 1 other identifier: HA1406-007
• Study Type: interventional
• Target: 770
• 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)

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

  From baseline to Week 8

Secondary Outcomes (13)

• Change from baseline in Hamilton Depression Scale (HAMD-17) at the end of treatment (week 8)

  From baseline to Week 8

• Change from baseline in The Clinical Global Impression Scale (CGI-S) scores at the end of treatment (week 8) at the end of treatment (week 8)

  From baseline to Week 8

• Clinical Global Impression Scale of Improvement (CGI-I) score at the end of treatment (week 8)

  Week 8

• The efficiency and remission of the MADRS score

  Baseline and week 8

• The efficiency and remission of the HAMD-17 score

  Baseline and week 8

Study Arms (4)

Ammoxetine group-cohort 1

EXPERIMENTAL

The eligible subjects will receive Ammoxetine plus placebo.

Drug: Ammoxetine

Ammoxetine group-cohort 2

EXPERIMENTAL

The eligible subjects will receive Ammoxetine plus placebo.

Drug: Ammoxetine

Placebo group

PLACEBO COMPARATOR

The eligible subjects will receive placebo.

Drug: Placebo

Sertraline group

ACTIVE COMPARATOR

The eligible subjects will receive Sertraline plus placebo.

Drug: Sertraline

Interventions

Ammoxetine DRUG

Drug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Ammoxetine and Sertraline.

Ammoxetine group-cohort 1

Placebo DRUG

Drug: Placebo placebo to Ammoxetine hydrochlorid and Sertraline.

Placebo group

Sertraline DRUG

Drug: Sertraline positive control Drug: Placebo placebo to Ammoxetine hydrochlorid.

Sertraline 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 (classification code 296.2/296.3).The duration of the current depressive episode should be ≥3 months for first-episode patients and ≥1 month for relapsing patients;
• \. 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. Score of first item (depressed mood) of the HAMD-17 scale ≥2 at the screening and baseline.
• Be able to read and understand the study procedures and trial requirements, agree to abide by the restrictions of the trial and return to the site on time for evaluation, and sign the informed consent form prior to the trial.

You may not qualify if:

• \. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
• \. There is a clinically significant risk of suicide or risk of self-injury and harm to others. Those who meet any of the following:
• A score of ≥4 on item 10 (Suicidal Ideation) of the MADRS scale;
• Subjects who in the judgment of the investigator, are at significant risk for suicide (e.g., participant answered "yes" to question 4 (active suicidal ideation with intent to act but no specific plan) or question 5 (active suicidal ideation with a specific plan and intent) on the Screening C-SSRS and the most recent suicidal intent or suicidal plan occurred within the last six months);
• Attempted suicide during the current depressive episode;
• \. Subjects meet DSM-5 diagnostic criteria for other mental disorders (Schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, substance-related and addiction disorders, etc.)
• \. Subjects who meet any of the following diagnoses of depressive disorders:
• Those who have been determined by the investigator to have TRD (current or prior use of 2 or more antidepressants with different mechanisms that have not been effective with a full course (at least 8 weeks) of treatment at the full dosage (the maximum recommended amount of the instructions);
• Subjects with depressive disorders due to other types of mental disorders or somatic diseases (e.g., depressive disorders due to hypothyroidism);
• Subjects with depressive disorders due to substances/drugs;
• \. Subjects who stopped using the following drugs for less than 5 half-lives prior to randomization:
• CYP2C19 and CYP3A4 strong inducers and strong inhibitors (e.g., fluoxetine, rifampicin, carbamazepine, etc.);
• Combined use of drugs that cause QTc interval prolongation (e.g., levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, and haloperidol, etc.) or drugs that can cause QTc interval prolongation and may induce torsade de pointes ventricular tachycardia;
• Antipsychotics, antidepressants, or mood stabilizers;
• \. Subjects who have failed previous treatment with a full course (at least 8 weeks) of sertraline at the maximum recommended dose or who have a known allergy to sertraline;

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ammoxetine; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 14, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share