Mood DisordersNCT06355180
Esketamine vs ECT for Acute Suicidality
A study testing Esketamine and Electroconvulsive therapy in people with Mood Disorders and Suicidal Ideation, run by Capital Medical University at 6 sites in China.
Trial summary
This study is a multicenter, randomized, non-inferiority, parallel-group clinical trial designed to evaluate the efficacy and safety of esketamine compared with electroconvulsive therapy (ECT) in the treatment of suicidal ideation during depressive episodes in patients with mood disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorders, Suicidal Ideation, Depressive Episode
- What is being tested?
- Esketamine and Electroconvulsive therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 6 sitesChina
- Study dates
- 16 Apr 2024to 28 Aug 2025
- Phase
- Interventional
- 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
Inclusion Criteria (all five criteria must be met for an individual to be included):
- Outpatients or inpatients aged 18 to 65 years (inclusive);
- Having a current diagnosis of MDD or depressive episode in bipolar I/II disorder, established using the Mini-International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2) and according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria;
- Having a total score of 6 or more on the SSI at screening;
- Having at least primary school education and the ability to comprehend assessment scales;
- Having provided written informed consent.
Exclusion Criteria (an individual will be excluded if any one of the following criteria is met):
- Having a current or historical diagnosis of neurodevelopmental, neurocognitive, psychotic, or substance-related disorders according to the DSM-5 criteria;
- Having active delusions or hallucinations;
- Suffering from severe/unstable systemic illness (illness affecting the central nervous system, cardiovascular, respiratory, hepatic, renal, endocrine, or hematologic systems) and judged by the investigator as unsuitable for participation;
- Being judged by the investigator as at risk for substance abuse or addiction;
- Using reserpine currently;
- Contraindications to general anesthesia;
- Having a history of seizure disorders (except for uncomplicated childhood febrile seizures);
- Having severe drug or food allergies or allergy to any component of the study medication;
- Having a history of treatment non-response or severe adverse reactions to esketamine, ketamine, or ECT;
- Having participated in any other clinical trials within the three months before the enrollment;
- Being pregnant, breastfeeding, or planning to become pregnant (for female participants) or planning to father a child (for male participants) during the study or within 12 weeks after the last dose of medication;
- Being judged by researchers as unsuitable for participation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088
Beijing Chaoyang District Third Hospital
Beijing
Beijing Daxing District Xinkang Hospital
Beijing
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali
Inner Mongolia Autonomous Region Mental Health Center
Hohhot
Wuhu Fourth People's Hospital
Wuhu, Anhui, 241002
About this study
Official title: Esketamine Versus Electroconvulsive Therapy for Suicidal Ideation in Depressive Episodes: a Multicenter Randomized Controlled Trial
This study is a multicenter, randomized, non-inferiority, parallel-group clinical trial designed to evaluate the efficacy and safety of esketamine compared with electroconvulsive therapy (ECT) in the treatment of suicidal ideation during depressive episodes in patients with mood disorders. Furthermore, it aims to investigate the potential mechanisms underlying the anti-suicidal effects of esketamine.
Read the detailed description
Suicide is a major global public health concern, yet current treatments for suicidal ideation (SI) remain limited in efficacy. This study evaluates whether a two-week course of six administrations of adjunctive intravenous esketamine is non-inferior to electroconvulsive therapy (ECT) in reducing SI among adults experiencing depressive episodes of mood disorders. This multicenter, randomized, non-inferiority, parallel-group trial will enroll 340 adults diagnosed with mood disorders with clinically significant SI during a depressive episode. Participants will be randomized in a 1:1 ratio to receive either six administrations of adjunctive intravenous esketamine or ECT over a two-week intervention period, followed by a 10-week observational follow-up phase (the total study duration will be 12 weeks). The primary outcome is the rate of remission of SI, defined as a Scale for Suicidal Ideation (SSI) score of less than 4, at the end of the two-week intervention. Secondary outcomes include comparative evaluations of treatment efficacy on depressive symptoms, cognitive function, quality of life, and social functioning, as well as safety. Exploratory outcomes include the identification of biomarker and neurobiological mechanisms of treatment response through analyses of biological specimens (blood, urine, and feces), multimodal magnetic resonance imaging (MRI), and electroencephalographic (EEG) measures.
- Conditions
- Mood Disorders, Suicidal Ideation, Depressive Episode
- Being tested
- Esketamine, Electroconvulsive therapy
- Keywords
- Esketamine, Depressive Episode, Suicidal Ideation, Mood Disorders, Multicenter, Randomized Controlled Study, Electroconvulsive therapy
- Medical subject headings
- Mood Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
The experimental group will receive intravenous esketamine hydrochloride. Participants will be asked to fast for 8 hours prior to administration. On treatment days, esketamine will be administered at a dose of 0.2 mg/kg, diluted in 0.9% sodium chloride solution. The infusion rate will be controlled with an infusion pump or syringe pump to ensure a minimum administration duration of 40 minutes. Treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks, totaling six sessions. For participants demonstrating intolerance to either the dose of 0.2 mg/kg or the six-session regimen, investigators could modify the treatment protocol based on efficacy and safety assessments.
Electroconvulsive therapyDevice
The control group will receive ECT. Prior to each session, participants will undergo safety evaluations and concomitant medication adjustments. Following an 8-hour fast and bladder evacuation, other preoperative preparations include intravenous administration of anticholinergic agents, short-acting anesthetics, and muscle relaxants. Electrodes will be placed unilaterally on the non-dominant hemisphere, with the seizure threshold determined via titration. The treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks (six sessions in total). The protocol permitted regimen modifications for participants unable to tolerate the full course, based on efficacy and safety assessments.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous esketamine | Experimental | The experimental group will receive six administrations of adjunctive intravenous esketamine over a two-week intervention period, followed by a 10-week observational follow-up phase. Receives: Drug: Esketamine |
| Electroconvulsive therapy | Active comparator | The control group will receive six administrations of adjunctive ECT over a two-week intervention period, followed by a 10-week observational follow-up phase. Receives: Device: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of suicidal ideation
The Scale for Suicide Ideation (SSI) is a 19-item clinician-administered scale assessing the severity of suicidal ideation. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 38, with higher scores indicating greater suicidal intent.
The primary outcome is the rate of remission of suicidal ideation following the 2-week intervention (after 6 treatments), with the remission of suicidal ideation defined as having an SSI score of less than 4 (which indicates the absence of clinically significant suicidal ideation).
Measured: Baseline, after the sixth treatments (week 2)
Secondary outcomes (20)
Remission rate of suicidal ideation
Compare the suicide ideation remission rates between the two groups after the first treatment, after the third treatment, at week 4, week 8, and week 12. Suicide remission rate is defined as an SSI score of less than 4.
Measured: Baseline, after the first treatment, after the third treatment, at week 4, week 8, and week 12
Rates of sustained remission and recurrence of suicide ideation
Sustained remission: Defined as having SSI scores of less than 4 in two consecutive assessments.
Recurrence: Defined as the emergence of suicidal behavior, an SSI score of 6 or more, or other composite indicators, following two consecutive assessments with SSI scores of less than 4.
Compare the sustained remission rates and recurrence rates of suicidal ideation between the two groups after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in SSI Scores
Compare the changes in SSI scores at each visit compared to baseline.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Compare the changes in C-SSRS scores at each visit compared to baseline.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Response rate of depressive symptoms
Response of depressive symptoms is defined as a 50% or more reduction from baseline in the Montgomery-Åsberg Depression Rating Scale(MADRS) score. Compare the response rates of depressive symptoms between the two groups at each visit.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Remission rate of depressive symptoms
Remission of depressive symptoms is defined as a MADRS score of less than 12. Compare the remission rates of depressive symptoms between the two groups at each visit.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Montgomery Asberg Depression Rating Scale (MADRS) Scores
Compare the changes in MADRS scores at each visit compared to baseline.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Quick Inventory of Depressive Symptoms Self Report (QIDS-SR-16) Scores
Compare the changes in QIDS-SR-16 scores at each visit compared to baseline.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Clinical Global Impressions (CGI) Scores
Compare the changes in CGI scores at each visit compared to baseline.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Short Form 12 Health Survey (SF-12) Scores
Self-reported questionnaire. The Short Form 12 Health Survey (SF-12) is a condensed version of the SF-36 health survey, designed to measure health-related quality of life. It includes 12 questions covering physical and mental health domains. These questions generate two main scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), which are standardized to a mean of 50 and a standard deviation of 10 in the general population.
Compare the changes in SF-12 scores at each visit compared to baseline.
Measured: Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Sheehan Disability Scale (SDS) Scores
Self-reported questionnaire. Scale Range: 0-30. Higher scores indicate greater functional impairment.
Compare the changes in SDS scores at each visit compared to baseline.
Measured: Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Digital Span Test (DST) Scores
Self-reported questionnaire. Scale Range: 0-22. Higher scores indicate better working memory and attention.
Compare the changes in DST scores at each visit compared to baseline.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Digit Symbol Substitution Test (DSST) Scores
Self-reported questionnaire. Scale Range: 0-90. Higher scores indicate better cognitive processing speed and attention.
Compare the changes in DSST scores at each visit compared to baseline.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Perceived Deficit Questionnaire for Depression 5-item (PDQ-D-5) Scores
Self-reported questionnaire. Scale Range: 0-20. Higher scores indicate a greater perceived cognitive deficit.
Compare the changes in PDQ-D-5 scores at each visit compared to baseline.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Young Mania Rating Scale (YMRS) Scores
Clinician rated scales. Scale Range: 0-60. Higher scores indicate more severe manic symptoms.
Compare the changes in YMRS scores at each visit compared to baseline.
Measured: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Clinician Administered Dissociative States Scale (CADSS) Scores
Clinician rated scales. Scale Range: 0-92. Higher scores indicate more severe dissociative symptoms.
Compare the changes in CADSS scores at each esketamine treatment compared to baseline.
Measured: Baseline, after the 1st, 2nd, 3rd, 4th, 5th, and 6th esketamine treatments
Adverse event
Compare the incidence of adverse events and serious adverse events between the two groups.
Measured: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in neuroimaging metrics
Explore changes in neuroimaging metrics after the sixth treatment compared to baseline.
Measured: Baseline, after the sixth treatments (week 2)
Changes in Electroencephalogram (EEG) metrics
Explore changes in EEG metrics after the first and sixth treatment compared to baseline.
Measured: Baseline, after the first treatment, after the sixth treatments (week 2)
Changes in biological indicators
Biological samples (blood, urine, and feces) will be collected from a subset of participants at baseline, after the first treatment, and after the sixth treatment for multi-omics profiling, including genomic, transcriptomic, epigenomic, metabolomic, microbiome, immunological, proteomic, and pharmacogenomic analyses.
Measured: Baseline, after the first treatment, after the sixth treatments (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start16 Apr 2024
- Primary completion13 Jun 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhu Fourth People's Hospital, The Second People's Hospital of Dali Bai Autonomous Prefecture, Inner Mongolia Autonomous Region Mental Health Center, Beijing Chaoyang District Third Hospital, Beijing Daxing District Xinkang Hospital
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
- Investigators
- Gang Wang, MD, Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355180
- Sponsor's protocol ID
- Shoudufazhan2024-1-2122
- Status last verified
- Aug 2025
- First submitted
- 27 Mar 2024
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine Versus Electroconvulsive Therapy for Suicidal Ideation in Depressive Episodes: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06355180
- Acronym / sponsor ID
- Shoudufazhan2024-1-2122
- Conditions
- Mood Disorders, Suicidal Ideation, Depressive Episode
- Keywords
- Esketamine, Depressive Episode, Suicidal Ideation, Mood Disorders, Multicenter, Randomized Controlled Study, Electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Wuhu Fourth People's Hospital, The Second People's Hospital of Dali Bai Autonomous Prefecture, Inner Mongolia Autonomous Region Mental Health Center, Beijing Chaoyang District Third Hospital, Beijing Daxing District Xinkang Hospital
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 9 Apr 2024 (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.
This study is a multicenter, randomized, non-inferiority, parallel-group clinical trial designed to evaluate the efficacy and safety of esketamine compared with electroconvulsive therapy (ECT) in the treatment of suicidal ideation during depressive episodes in patients with mood disorders. Furthermore, it aims to investigate the potential mechanisms underlying the anti-suicidal effects of esketamine.
Detailed description
Suicide is a major global public health concern, yet current treatments for suicidal ideation (SI) remain limited in efficacy. This study evaluates whether a two-week course of six administrations of adjunctive intravenous esketamine is non-inferior to electroconvulsive therapy (ECT) in reducing SI among adults experiencing depressive episodes of mood disorders. This multicenter, randomized, non-inferiority, parallel-group trial will enroll 340 adults diagnosed with mood disorders with clinically significant SI during a depressive episode. Participants will be randomized in a 1:1 ratio to receive either six administrations of adjunctive intravenous esketamine or ECT over a two-week intervention period, followed by a 10-week observational follow-up phase (the total study duration will be 12 weeks). The primary outcome is the rate of remission of SI, defined as a Scale for Suicidal Ideation (SSI) score of less than 4, at the end of the two-week intervention. Secondary outcomes include comparative evaluations of treatment efficacy on depressive symptoms, cognitive function, quality of life, and social functioning, as well as safety. Exploratory outcomes include the identification of biomarker and neurobiological mechanisms of treatment response through analyses of biological specimens (blood, urine, and feces), multimodal magnetic resonance imaging (MRI), and electroencephalographic (EEG) measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous esketamine | Experimental | Drug: EsketamineThe experimental group will receive six administrations of adjunctive intravenous esketamine over a two-week intervention period, followed by a 10-week observational follow-up phase. |
| Electroconvulsive therapy | Active comparator | Device: Electroconvulsive therapyThe control group will receive six administrations of adjunctive ECT over a two-week intervention period, followed by a 10-week observational follow-up phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EsketamineThe experimental group will receive intravenous esketamine hydrochloride. Participants will be asked to fast for 8 hours prior to administration. On treatment days, esketamine will be administered at a dose of 0.2 mg/kg, diluted in 0.9% sodium chloride solution. The infusion rate will be controlled with an infusion pump or syringe pump to ensure a minimum administration duration of 40 minutes. Treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks, totaling six sessions. For participants demonstrating intolerance to either the dose of 0.2 mg/kg or the six-session regimen, investigators could modify the treatment protocol based on efficacy and safety assessments. | Drug | Intravenous esketamine |
| Electroconvulsive therapyThe control group will receive ECT. Prior to each session, participants will undergo safety evaluations and concomitant medication adjustments. Following an 8-hour fast and bladder evacuation, other preoperative preparations include intravenous administration of anticholinergic agents, short-acting anesthetics, and muscle relaxants. Electrodes will be placed unilaterally on the non-dominant hemisphere, with the seizure threshold determined via titration. The treatment will be administered three times per week (the recommended interval between sessions is 1 to 2 days, adjustable based on clinical judgment) for two consecutive weeks (six sessions in total). The protocol permitted regimen modifications for participants unable to tolerate the full course, based on efficacy and safety assessments. | Device | Electroconvulsive therapy |
Primary outcome
Remission rate of suicidal ideation
Time frame: Baseline, after the sixth treatments (week 2)
The Scale for Suicide Ideation (SSI) is a 19-item clinician-administered scale assessing the severity of suicidal ideation. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 38, with higher scores indicating greater suicidal intent. The primary outcome is the rate of remission of suicidal ideation following the 2-week intervention (after 6 treatments), with the remission of suicidal ideation defined as having an SSI score of less than 4 (which indicates the absence of clinically significant suicidal ideation).
20 secondary outcomes
Remission rate of suicidal ideation
Time frame: Baseline, after the first treatment, after the third treatment, at week 4, week 8, and week 12
Rates of sustained remission and recurrence of suicide ideation
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in SSI Scores
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Response rate of depressive symptoms
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Remission rate of depressive symptoms
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Montgomery Asberg Depression Rating Scale (MADRS) Scores
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Quick Inventory of Depressive Symptoms Self Report (QIDS-SR-16) Scores
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Clinical Global Impressions (CGI) Scores
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Short Form 12 Health Survey (SF-12) Scores
Time frame: Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Sheehan Disability Scale (SDS) Scores
Time frame: Baseline, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Digital Span Test (DST) Scores
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Digit Symbol Substitution Test (DSST) Scores
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Perceived Deficit Questionnaire for Depression 5-item (PDQ-D-5) Scores
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Young Mania Rating Scale (YMRS) Scores
Time frame: Baseline, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in Clinician Administered Dissociative States Scale (CADSS) Scores
Time frame: Baseline, after the 1st, 2nd, 3rd, 4th, 5th, and 6th esketamine treatments
Adverse event
Time frame: Baseline, after the first treatment, after the third treatment, after the sixth treatment (week 2), at week 4, week 8, and week 12
Changes in neuroimaging metrics
Time frame: Baseline, after the sixth treatments (week 2)
Changes in Electroencephalogram (EEG) metrics
Time frame: Baseline, after the first treatment, after the sixth treatments (week 2)
Changes in biological indicators
Time frame: Baseline, after the first treatment, after the sixth treatments (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 5 Sep 2025.
- 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.
Gang Wang, MD principal investigator
Beijing Anding Hospital, Capital Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Electroconvulsive therapy in people with Mood Disorders and Suicidal Ideation, run by Capital Medical University at 6 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?
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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Remission rate of suicidal ideation (time frame: Baseline, after the sixth treatments (week 2)). 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 5 Sep 2025.