Major Depressive Disorder (MDD)Phase 3NCT06827431
The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
A Phase 3 study testing Ammoxetine and Sertraline in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites 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 and Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 786 participants
- Where
- 2 sitesChina
- Study dates
- 21 Feb 2025to 20 Aug 2026
- Phase
- Phase 3
- 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 (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.
Who cannot join
- 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:
- 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;
- 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.)
Show all 38Show fewer
- 4. 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;
- 5. 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;
- 6. 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;
- 7. Subjects who stopped using MAOI (e.g., phenelzine, isocarbazide, antiphencyclidine, linezolid, methylene blue, etc.) for less than 2 weeks before randomization;
- 8. Subjects on long half-life antipsychotics;
- 9. 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.)
- Systemic Transcranial magnetic stimulation therapy (TMS)
- Systemic Vagus Nerve Stimulation (VNS)
- Systemic Light therapy, etc.
- Or those who, in the judgment of the investigator, currently require the above treatments
- 10. Participation in any clinical trial within 3 months prior to screening;
- 11. 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.)
- 12. 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);
- 13. Allergic constitution (e.g. allergic to two or more drugs or to SNRIs);
- 14. Prior history of seizures; or any other condition that increases the risk of seizures (e.g., stroke, severe head trauma, significant metabolic disorders, etc.);
- 15. 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;
- 16. 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;
- 17. Previous history of increased intraocular pressure or narrow-angle glaucoma;
- 18. Subjects with conditions that interfere with the absorption of oral medications, such as active enteropathy, partial or complete intestinal obstruction, and chronic diarrhea, etc;
- 19. Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study;
- 20. Alcohol or drug dependence within 3 months before screening;
- 21. 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;
- 22. The subject meets any of the following conditions: unable to read or understand the study procedures or trial requirements; unwilling to comply with the trial restrictions or unable to return to the study site for assessments as scheduled; unable to personally provide informed consent (sign the informed consent form) prior to the trial.
- 23. 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
2 sites in 1 country.
China2 sites
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100000
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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
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, 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Ammoxetine, Placebo, Sertraline
- 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
Drug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Ammoxetine and Sertraline.
AmmoxetineDrug
Drug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Sertraline.
PlaceboDrug
Drug: Placebo placebo to Ammoxetine hydrochlorid and Sertraline.
SertralineDrug
Drug: Sertraline positive control Drug: Placebo placebo to Ammoxetine hydrochlorid.
| Study group | Role | What they receive |
|---|---|---|
| Ammoxetine group-cohort 1 | Experimental | The eligible subjects will receive Ammoxetine plus placebo. Receives: Drug: Ammoxetine |
| Ammoxetine group-cohort 2 | Experimental | The eligible subjects will receive Ammoxetine plus placebo. Receives: Drug: Ammoxetine |
| Placebo group | Placebo comparator | The eligible subjects will receive placebo. Receives: Drug: Placebo |
| Sertraline group | Active comparator | The eligible subjects will receive Sertraline plus placebo. Receives: Drug: Sertraline |
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: From baseline to Week 8
Secondary outcomes (13)
Change from baseline in Hamilton Depression Scale (HAMD-17) at the end of treatment (week 8)
The HAMD-17 is a clinician-based assessment of depressive symptoms. The total score ranges from 0 to 53 with a higher score indicating more depression. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
Measured: 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)
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Measured: From baseline to Week 8
Clinical Global Impression Scale of Improvement (CGI-I) score at the end of treatment (week 8)
The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms of depression. It is a 7-point scale where a score of 1 indicates that the participant is "very much improved," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse."
Measured: Week 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 MADRS score ≤ 10 after treatment.
Measured: Baseline and week 8
The efficiency and remission of the HAMD-17 score
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 and week 8
CGI-I score
The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms of depression. It is a 7-point scale where a score of 1 indicates that the participant is "very much improved," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse."
Measured: Week 1, week 2, week 4 and week 6
Change from baseline in HAMD-17 score
The HAMD-17 is a clinician-based assessment of depressive symptoms. The total score ranges from 0 to 53 with a higher score indicating more depression. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
Measured: Week 1, week 2, week 4 and week 6
Change from baseline in MADRS score
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: Week 1, week 2, week 4 and week 6
Change from baseline in HAMA score
The HAMA is a clinician-rated instrument administered to assess severity of anxiety, its improvement during the course of treatment, and the timing of such improvement. This instrument will be completed by qualified and trained Investigator site raters based on a semi-structured interview for his/her assessment of the participant. The scale consists of 14 items. Each item is rated on a scale of 0 (feeling not present) to 4 (very severe prevalence of the feeling). The HAMA total score is the sum of the 14 items and the score ranges from 0 to 56.
Measured: Week 1, week 2, week 4 and week 6
Change from baseline in CGI-S score
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Measured: Week 1, week 2, week 4 and week 6
The efficiency and remission of the HAMD-17 score
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: Week 1, week 2, week 4 and week 6
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 MADRS score ≤ 10 after treatment.
Measured: Week 1, week 2, week 4 and week 6
The percentage of subjects with a MARDS score reduction ≥ 25%
Measured: Week 1and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start21 Feb 2025
- Primary completion14 Jul 2026
- Study completion20 Aug 2026
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827431
- Sponsor's protocol ID
- HA1406-007
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2024
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06827431
- Acronym / sponsor ID
- HA1406-007
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 14 Feb 2025 (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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ammoxetine group-cohort 1 | Experimental | Drug: AmmoxetineThe eligible subjects will receive Ammoxetine plus placebo. |
| Ammoxetine group-cohort 2 | Experimental | Drug: AmmoxetineThe eligible subjects will receive Ammoxetine plus placebo. |
| Placebo group | Placebo comparator | Drug: PlaceboThe eligible subjects will receive placebo. |
| Sertraline group | Active comparator | Drug: SertralineThe eligible subjects will receive Sertraline plus placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 (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.
Key exclusion criteria (38 listed)
- 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:
- 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:
- 5. Subjects who stopped using the following drugs for less than 5 half-lives prior to randomization:
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 |
|---|---|---|
| AmmoxetineDrug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Ammoxetine and Sertraline. | Drug | Ammoxetine group-cohort 1 |
| AmmoxetineDrug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Sertraline. | Drug | Ammoxetine group-cohort 2 |
| PlaceboDrug: Placebo placebo to Ammoxetine hydrochlorid and Sertraline. | Drug | Placebo group |
| SertralineDrug: Sertraline positive control Drug: Placebo placebo to Ammoxetine hydrochlorid. | Drug | Sertraline group |
Primary outcome
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
Time frame: 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
13 secondary outcomes
Change from baseline in Hamilton Depression Scale (HAMD-17) at the end of treatment (week 8)
Time frame: 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)
Time frame: From baseline to Week 8
Clinical Global Impression Scale of Improvement (CGI-I) score at the end of treatment (week 8)
Time frame: Week 8
The efficiency and remission of the MADRS score
Time frame: Baseline and week 8
The efficiency and remission of the HAMD-17 score
Time frame: Baseline and week 8
CGI-I score
Time frame: Week 1, week 2, week 4 and week 6
Change from baseline in HAMD-17 score
Time frame: Week 1, week 2, week 4 and week 6
Change from baseline in MADRS score
Time frame: Week 1, week 2, week 4 and week 6
Change from baseline in HAMA score
Time frame: Week 1, week 2, week 4 and week 6
Change from baseline in CGI-S score
Time frame: Week 1, week 2, week 4 and week 6
The efficiency and remission of the HAMD-17 score
Time frame: Week 1, week 2, week 4 and week 6
The efficiency and remission of the MADRS score
Time frame: Week 1, week 2, week 4 and week 6
The percentage of subjects with a MARDS score reduction ≥ 25%
Time frame: Week 1and week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ammoxetine and Sertraline in people with Major Depressive Disorder (MDD), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites 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 4 inclusion and 38 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: From baseline to Week 8). 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 30 Oct 2026.