Loading clinical trials...

The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Double-Dummy, Placebo-controlled and Sertraline Active-controlled, Parallel-group, Phase III Study

NCT06827431•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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, double-dummy, placebo-controlled and Sertraline active-controlled multicenter study will be conducted to evaluate the efficacy and safety of different doses of Ammoxetine hydrochloride enteric coated tablets in the treatment of depression.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 (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;
•3\. 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.

Exclusion Criteria

•1\. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
•2\. There is a clinically significant risk of suicide or risk of self-injury and harm to others. Those who meet any of the following:
•1. A score of ≥4 on item 10 (Suicidal Ideation) of the MADRS scale;
•2. 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);
•3. Attempted suicide during the current depressive episode;
•3\. 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.)
•4\. Subjects who meet any of the following diagnoses of depressive disorders:
•1. 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);
•2. Subjects with depressive disorders due to other types of mental disorders or somatic diseases (e.g., depressive disorders due to hypothyroidism);
•3. Subjects with depressive disorders due to substances/drugs;
+27 more criteria

Key Dates

Start Date

February 14, 2025

Primary Completion Date

June 30, 2026

Completion Date

September 30, 2026

Last Updated

February 14, 2025

Enrollment

770

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD)

Interventions

Ammoxetine

DRUG

Ammoxetine

DRUG

Placebo

DRUG

Sertraline

DRUG

Contacts

Clinical Trials Information Group officer

CONTACT

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

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

View study

RECRUITINGNA

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

NCT07025720

Major Depressive Disorder (MDD)Suicidal Ideation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Group Therapy for Major Depression: Comparing Expectation-Focused and Reward-Focused Psychotherapy Approaches

Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)

Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine