Major Depressive Disorder (MDD)Phase 2NCT05018013
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
A Phase 2 study testing Ammoxetine hydrochloride enteric-coated tablets and Duloxetine hydrochloride enteric-coated capsules in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 hydrochloride enteric-coated tablets and Duloxetine hydrochloride enteric-coated capsules
- 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
- 1 siteChina
- Study dates
- 21 Aug 2021to 30 Dec 2022
- 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
- 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 (DSM-IV-TR criteria, classification code 296.2/296.3), without psychotic symptoms;
- 3. Subjects with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 and subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline;
- 4. For 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;
- 5. Be able to read and understand the content of the informed consent and voluntarily sign the informed consent.
Who cannot join
- 1. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
- 2. 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.);
- 3. Subjects are diagnosed as DSM-5 drug use disorder;
- 4. Refractory depression (subjects who had previously used two different mechanisms of antidepressants and failed after receiving adequate treatment (at least 8 weeks);
- 5. Organic mental disorders, such as depression caused by hypothyroidism;
- 6. Depression caused by psychoactive substances or non-addictive substances;
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- 7. Subjects with other diseases or other types of mental disorders with depressive symptoms;
- 8. 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 behaviour within 6 months prior to screening;
- 9. Allergic constitution (e.g. allergic to two or more drugs or to serotonin norepinephrine reuptake inhibitors (SNRIs));
- 10.Previous history of malignant tumor;
- 11.Previous history of elevated intraocular pressure or narrow angle glaucoma;
- 12.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;
- 13.Subjects with diseases that interfere with the absorption of oral medications, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc;
- 14.Subjects who have used drugs or foods that alter the activity of liver enzymes (CYP2C19 and CYP3A4) such as dexamethasone, rifampicin, omeprazole, grapefruit, etc., within 4 weeks prior to screening;
- 15.12-lead ECG system showed degree II or III atrioventricular block, long QT syndrome or QTc > 450 ms (male) / 470 ms (female) at screening;
- 16.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;
- 17.In screening period, subjects with ALT or AST 1.5 times higher than the upper limit of laboratory normal value; creatinine 1.1 times higher than the upper limit of 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);
- 18.Subjects have used monoamine oxidase inhibitors within 2 weeks before randomization;
- 19.Subjects discontinuing antipsychotics, antidepressants or mood stabilizers for less than 5 half-lives of the drug before randomization;
- 20.Subjects who are using long half-life drugs (such as fluoxetine, long-acting antipsychotics, etc.);
- 21.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;
- 22.Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study;
- 23.Alcohol or drug dependence within 3 months before screening;
- 24.Subjects who have participated in other clinical trials within 3 months before screening and are taking the test drug;
- 25.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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Li Huafang, Ph.D, 86-021-34773128
About this study
Official title: Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Double-dummy, Active- and 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, duloxetine hydrochloride enteric coated capsule positive and placebo-controlled multicenter study was used to evaluate the efficacy and safety of different doses of amxetine hydrochloride enteric coated tablets in the treatment of depression.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Ammoxetine hydrochloride enteric-coated tablets, Duloxetine hydrochloride enteric-coated capsules, Placebo to Ammoxetine, Placebo to Duloxetine
- 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.
Ammoxetine hydrochloride enteric-coated tabletsDrug
Also called Ammoxetine
Ammoxetine hydrochloride enteric-coated tablets
Duloxetine hydrochloride enteric-coated capsulesDrug
Also called Duloxetine
Duloxetine hydrochloride enteric-coated capsules
Placebo to AmmoxetineDrug
Also called Placebo
Placebo to Ammoxetine
Placebo to DuloxetineDrug
Also called Placebo
Placebo to Duloxetine
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine group | Active comparator | The eligible subjects will receive duloxetine hydrochloride enteric-coated capsules plus placebo to Ammoxetine. Receives: Drug: Duloxetine hydrochloride enteric-coated capsules; Drug: Placebo to Ammoxetine |
| Placebo group | Placebo comparator | The eligible subjects will receive placebo to Ammoxetine and placebo to Duloxetine. Receives: Drug: Placebo to Ammoxetine; Drug: Placebo to Duloxetine |
| Ammoxetine group-cohort 1 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine |
| Ammoxetine group-cohort 2 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine |
| Ammoxetine group-cohort 3 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine |
| Ammoxetine group-cohort 4 | Experimental | The eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets; Drug: Placebo to Duloxetine |
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 6)
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.
Change = (Week 6 post-dose score - baseline week 0 score). at the end of treatment (week 6)
Measured: Baseline and week 6
Secondary outcomes (6)
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6
The HAMD-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Change = (Week 1, 2, 4 and 6 post-dose score - baseline week 0 score).
Measured: Baseline, week 1, 2, 4 and 6
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6
The HAMA is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAMA total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Change = (Week 1, 2, 4 and 6 post-dose score - baseline week 0 score).
Measured: Baseline, week 1, 2, 4 and 6
Change from baseline in CGI-S score at week 1, 2, 4, 6,7
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.
Change = (Week 1, 2, 4, 6 and 7 post-dose score - baseline week 0 score).
Measured: Baseline, week 1, 2, 4, 6 and 7
The percentage of subjects with a MARDS score reduction ≥ 25%
The score reduction rate is defined as (screening period MARDS scale score - post-dose MARDS scale score)/screening period MARDS scale score x 100%.
Measured: Week 1 and 2
Incidence of adverse events (AE)
The AEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
Measured: Throughout the study period,an average of 18 months
Change from baseline in MADRS score at week 1, 2, 4
Change = (Week 1, 2 and 4 post-dose score - baseline week 0 score).
Measured: baseline, week 1, 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start21 Aug 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang Yanli, MD, Study director, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., LtdLi Huafang, Ph.D, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018013
- Sponsor's protocol ID
- HA1406-CSP-003
- Status last verified
- Nov 2021
- First submitted
- 30 Jul 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. 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, Double-dummy, Active- and Placebo-controlled, Parallel-group, Phase II Study
- ClinicalTrials.gov ID
- NCT05018013
- Acronym / sponsor ID
- HA1406-CSP-003
- Conditions
- Major Depressive Disorder (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
- 21 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 24 Aug 2021 (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, duloxetine hydrochloride enteric coated capsule positive and placebo-controlled multicenter study was used to evaluate the efficacy and safety of different doses of amxetine hydrochloride enteric coated tablets in the treatment of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Duloxetine group | Active comparator | Drug: Duloxetine hydrochloride enteric-coated capsules, Drug: Placebo to AmmoxetineThe eligible subjects will receive duloxetine hydrochloride enteric-coated capsules plus placebo to Ammoxetine. |
| Placebo group | Placebo comparator | Drug: Placebo to Ammoxetine, Drug: Placebo to DuloxetineThe eligible subjects will receive placebo to Ammoxetine and placebo to Duloxetine. |
| Ammoxetine group-cohort 1 | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tablets, Drug: Placebo to DuloxetineThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. |
| Ammoxetine group-cohort 2 | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tablets, Drug: Placebo to DuloxetineThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. |
| Ammoxetine group-cohort 3 | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tablets, Drug: Placebo to DuloxetineThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. |
| Ammoxetine group-cohort 4 | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tablets, Drug: Placebo to DuloxetineThe eligible subjects will receive Ammoxetine hydrochloride enteric-coated tablets plus placebo to Duloxetine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (DSM-IV-TR criteria, classification code 296.2/296.3), without psychotic symptoms;
- 3. Subjects with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 and subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline;
- 4. For 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;
- 5. Be able to read and understand the content of the informed consent and voluntarily sign the informed consent.
Key exclusion criteria (25 listed)
- 1. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;
- 2. 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.);
- 3. Subjects are diagnosed as DSM-5 drug use disorder;
- 4. Refractory depression (subjects who had previously used two different mechanisms of antidepressants and failed after receiving adequate treatment (at least 8 weeks);
- 5. 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 |
|---|---|---|
| Ammoxetine hydrochloride enteric-coated tabletsAlso: AmmoxetineAmmoxetine hydrochloride enteric-coated tablets | Drug | Ammoxetine group-cohort 1, Ammoxetine group-cohort 2, Ammoxetine group-cohort 3, Ammoxetine group-cohort 4 |
| Duloxetine hydrochloride enteric-coated capsulesAlso: DuloxetineDuloxetine hydrochloride enteric-coated capsules | Drug | Duloxetine group |
| Placebo to AmmoxetineAlso: PlaceboPlacebo to Ammoxetine | Drug | Duloxetine group, Placebo group |
| Placebo to DuloxetineAlso: PlaceboPlacebo to Duloxetine | Drug | Ammoxetine group-cohort 1, Ammoxetine group-cohort 2, Ammoxetine group-cohort 3, Ammoxetine group-cohort 4, Placebo group |
Primary outcome
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 6)
Time frame: Baseline and week 6
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. Change = (Week 6 post-dose score - baseline week 0 score). at the end of treatment (week 6)
6 secondary outcomes
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 1, 2, 4, 6
Time frame: Baseline, week 1, 2, 4 and 6
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 1, 2, 4, 6
Time frame: Baseline, week 1, 2, 4 and 6
Change from baseline in CGI-S score at week 1, 2, 4, 6,7
Time frame: Baseline, week 1, 2, 4, 6 and 7
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,an average of 18 months
Change from baseline in MADRS score at week 1, 2, 4
Time frame: baseline, week 1, 2 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- 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.
Huang Yanli, MD study director
CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd
Li Huafang, Ph.D study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ammoxetine hydrochloride enteric-coated tablets and Duloxetine hydrochloride enteric-coated capsules in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 5 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Li Yang, MA (+86-13321898532 ext. +86-021606739, lcliyang@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 6) (time frame: Baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2021.