Major Depressive Disorder (MDD)Phase 2AmmoxetineNCT05762458
The Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
A Phase 2 study testing Ammoxetine in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Ammoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2023to 15 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 12-lead ECG system showed degree Ⅱ or Ш atrioventricular block, long QT syndrome or QTc > 450 ms (male) / 460 ms (female) at screening;
- Subjects discontinued use of a combination of drugs that prolong the QT interval prior to randomization, or drugs that can cause prolongation of the QT and may induce TdP for less than 5 half-lives of the drugs;
- In screening period, subjects with ALT or AST 2 times higher than the upper limit of laboratory normal value; and abnormalities in 2 or more of the 5 indicators of thyroid function (TSH, FT3, FT4, TT3 or TT4 0.9 times below the lower limit of normal value or 1.1 times above the upper limit of normal value);
- Subjects have used monoamine oxidase inhibitors within 2 weeks before randomization;
- Subjects discontinuing antipsychotics, antidepressants or mood stabilizers for less than 5 half-lives of the drug before randomization;
- Subjects who are using long half-life drugs (such as fluoxetine, long-acting antipsychotics, etc.);
- Subjects who have received electroconvulsive therapy (ECT), systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavior therapy, etc.), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), phototherapy, etc. within 3 months before screening, or subjects who, in the judgment of the investigator, are currently in need of such treatment;
- 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;
- Subjects who have participated in other clinical trials within 3 months before screening and are taking the test drug;
- Subjects who, in the opinion of the investigator, have any other condition that makes them unsuitable for participation in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase Ⅱ Study
The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.
Read the detailed description
In this study, a randomized, double-blind, placebo-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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Ammoxetine, Placebo
- Keywords
- MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmmoxetineDrug
Ammoxetine hydrochloride enteric-coated tablets
PlaceboDrug
placebo to Ammoxetine.
| Study group | Role | What they receive |
|---|---|---|
| Ammoxetine group-cohort 1 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo. Receives: Drug: Ammoxetine; Drug: Placebo |
| Ammoxetine group-cohort 2 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo. Receives: Drug: Ammoxetine; Drug: Placebo |
| Placebo group | Placebo comparator | The eligible subjects will receive placebo to Ammoxetine. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 8
Secondary outcomes (9)
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6, 8
Measured: Baseline, week 1, 2, 4 ,6 and 8
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6, 8
Measured: Baseline, week 1, 2, 4 ,6 and 8
Change from baseline in CGI-S score at week 1, 2, 4, 6, 8
Measured: Baseline, week 1, 2, 4, 6 and 8
Change from baseline in MADRS score at week 1, 2, 4, 6
Measured: 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
Measured: Baseline, week 1, 2, 4, 6 and 8
The efficiency and remission of the MADRS score
Effectiveness is defined as ≥ 50% reduction in MADRS score relative to baseline after treatment. Remission is defined as ≤ 10 MADRS score after treatment.
Measured: Baseline, Baseline, week 1, 2, 4, 6 and 8
Efficacy and remission of HAMD-17 scores
Effectiveness is defined as ≥50% reduction in HAMD-17 score relative to baseline after treatment. Remission is defined as HAMD-17 score ≤7 after treatment.
Measured: Baseline, week 1, 2, 4, 6 and 8
The percentage of subjects with a MARDS score reduction ≥ 25%
Measured: Week 1 and 2
Incidence of adverse events (AE)
Measured: Throughout the study period（From baseline to week 10）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start28 Feb 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762458
- Sponsor's protocol ID
- HA1406-005
- Acronym
- Ammoxetine
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40982284
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase Ⅱ Study
- ClinicalTrials.gov ID
- NCT05762458
- Acronym / sponsor ID
- Ammoxetine / HA1406-005
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, placebo-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ammoxetine group-cohort 1 | Experimental | Drug: Ammoxetine, Drug: PlaceboThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo. |
| Ammoxetine group-cohort 2 | Experimental | Drug: Ammoxetine, Drug: PlaceboThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo. |
| Placebo group | Placebo comparator | Drug: PlaceboThe eligible subjects will receive placebo to Ammoxetine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmmoxetineAmmoxetine hydrochloride enteric-coated tablets | Drug | Ammoxetine group-cohort 1, Ammoxetine group-cohort 2 |
| Placeboplacebo to Ammoxetine. | Drug | Ammoxetine group-cohort 1, Ammoxetine group-cohort 2, Placebo group |
Primary outcome
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
Time frame: Baseline and 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.
9 secondary outcomes
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6, 8
Time frame: Baseline, week 1, 2, 4 ,6 and 8
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6, 8
Time frame: Baseline, week 1, 2, 4 ,6 and 8
Change from baseline in CGI-S score at week 1, 2, 4, 6, 8
Time frame: Baseline, week 1, 2, 4, 6 and 8
Change from baseline in MADRS score at week 1, 2, 4, 6
Time frame: 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
Time frame: Baseline, week 1, 2, 4, 6 and 8
The efficiency and remission of the MADRS score
Time frame: Baseline, Baseline, week 1, 2, 4, 6 and 8
Efficacy and remission of HAMD-17 scores
Time frame: Baseline, week 1, 2, 4, 6 and 8
The percentage of subjects with a MARDS score reduction ≥ 25%
Time frame: Week 1 and 2
Incidence of adverse events (AE)
Time frame: Throughout the study period（From baseline to week 10）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 40982284He 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ammoxetine in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Qian (+86-15893878757, zhaoq@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8) (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.