NCT06827431尚未招募3 期
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 770 人开始时间: 2025年2月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 770
- 主要终点
- Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Subjects who stopped using MAOI (e.g., phenelzine, isocarbazide, antiphencyclidine, linezolid, methylene blue, etc.) for less than 2 weeks before randomization;
- •Subjects on long half-life antipsychotics;
- •Subjects who have received any of the following non-pharmacologic treatments within 3 months prior to screening:
- •Electroconvulsive therapy (ECT)
- •Systemic psychotherapy (e.g., interpersonal therapy, motivational therapy, cognitive behavioral therapy, etc.)
- •Transcranial magnetic stimulation therapy (TMS)
- •Vagus Nerve Stimulation (VNS)
- •Light therapy, etc.
- •Or those who, in the judgment of the investigator, currently require the above treatments
- •Participation in any clinical trial within 3 months prior to screening;
- •Those with degree II or III AV block, long QT syndrome, or QTcF >450 ms (males)/460 ms (females) on 12-lead ECG at the time of screening, or those deemed unsuitable for enrollment by the investigator (e.g., tachyarrhythmias requiring clinical management, etc.)
- •Screening subjects with ALT or AST greater than 2 times the upper limit of laboratory normal; Severe subclinical hypothyroidism (thyroid function indices only with abnormally elevated TSH and TSH ≥ 10.0 mIU/L); Abnormalities in 2 or more of the 5 thyroid function parameters (TSH, FT3, FT4, TT3, or TT4 values less than 0.9 times the lower limit of normal or more than 1.1 times the upper limit of normal);
- •Allergic constitution (e.g. allergic to two or more drugs or to SNRIs);
- •Prior history of seizures; or any other condition that increases the risk of seizures (e.g., stroke, severe head trauma, significant metabolic disorders, etc.);
- •By the judgment of the investigator, presence of any clinically significant hematologic, endocrine/metabolic, cardiovascular, respiratory, renal, hepatic, gastrointestinal, infectious, or neurological disease or the presence of an unstable or progressive chronic disease that unsuitable for entry into the study;
- •History of malignancy, including solid tumors, hematologic malignancies, and carcinoma in situ (except completely resected and cured basal cell carcinoma of the skin, squamous cell carcinoma, and carcinoma in situ of the cervix), within 5 years prior to screening;
- •Previous history of increased intraocular pressure or narrow-angle glaucoma;
- •Subjects with conditions that interfere with the absorption of oral medications, such as active enteropathy, partial or complete intestinal obstruction, and chronic diarrhea, etc;
- •Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study;
- •Alcohol or drug dependence within 3 months before screening;
- •Male or female with fertility do not agree to use an effective method of contraception during the study and for 1 month after the end of the trial to ensure that contraception is effective for the sexual partner or for themselves;
- •Subjects who in the opinion of the investigator, have any other condition that makes them unsuitable for participation in this trial.
研究组 & 干预措施
Placebo group
Placebo Comparator
The eligible subjects will receive placebo.
干预措施: Placebo (Drug)
Ammoxetine group-cohort 1
Experimental
The eligible subjects will receive Ammoxetine plus placebo.
干预措施: Ammoxetine (Drug)
Ammoxetine group-cohort 2
Experimental
The eligible subjects will receive Ammoxetine plus placebo.
干预措施: Ammoxetine (Drug)
Sertraline group
Active Comparator
The eligible subjects will receive Sertraline plus placebo.
干预措施: Sertraline (Drug)
结局指标
主要结局
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
时间窗: From baseline to 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
次要结局
- Change from baseline in Hamilton Depression Scale (HAMD-17) 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)
- CGI-I score(Week 1, week 2, week 4 and week 6)
- 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)
- Change from baseline in CGI-S score(Week 1, week 2, week 4 and week 6)
- The efficiency and remission of the MADRS score(Week 1, week 2, week 4 and week 6)
- Change from baseline in HAMD-17 score(Week 1, week 2, week 4 and week 6)
- The efficiency and remission of the HAMD-17 score(Week 1, week 2, week 4 and week 6)
- Change from baseline in MADRS score(Week 1, week 2, week 4 and week 6)
- Change from baseline in HAMA score(Week 1, week 2, week 4 and week 6)
- The percentage of subjects with a MARDS score reduction ≥ 25%(Week 1and week 2)
研究者
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