Major DepressionNCT07463911
Treatment Response In ECT Patients
An observational study of Major Depression and Bipolar Affective Disorder, run by Nurdan Sağbaş at 1 site in Turkey (Türkiye).
Trial summary
Clarification Regarding Study Type: Observational This study is a prospective, non-interventional observational study. The decision to administer Electroconvulsive Therapy (ECT) and the selection of the anesthetic agent (ketamine + propofol or propofol alone) are made entirely by the treating psychiatrist as part of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Bipolar Affective Disorder, Bipolar Depression Depressed Phase
- What is being tested?
- Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 20 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Being an inpatient at Pamukkale University Faculty of Medicine, Department of Mental Health and Diseases Hospital
Who may be able to join
- Diagnosed with depression or bipolar depression according to DSM-5
- Having an indication for ECT (Electroconvulsive Therapy)
Who cannot join
- Mental limitations such as intellectual disability
- Refusal to undergo ECT
- Patients not suitable for general anesthesia
- Substance use disorder
- Alcohol dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study Of Suıcıdal Ideatıon, Dıssocıactive Symptoms And Treatment Response In Psychıatrıc Patients Receıvıng Electroconvulsıve Therapy
Clarification Regarding Study Type: Observational
This study is a prospective, non-interventional observational study. The decision to administer Electroconvulsive Therapy (ECT) and the selection of the anesthetic agent (ketamine + propofol or propofol alone) are made entirely by the treating psychiatrist as part of routine clinical practice, independent of and prior to any research-related activities. Participants are not assigned to anesthetic groups by the investigators; rather, they are observed and grouped according to the anesthetic regimen already determined by their clinical team based on standard medical care. The investigators do not intervene in, alter, or influence the treatment process in any way. Data collection consists solely of administering validated psychiatric rating scales at predefined time points to monitor naturally occurring clinical outcomes. Therefore, this study meets the definition of an observational study as outlined in the Protocol Registration Data Element Definitions: participants receive interventions as part of routine medical care, and the researcher studies the effect of the intervention without assigning it.
Read more
Summary of the Study
This research project, titled "A Prospective Observational Study of Suicidal Ideation, Dissociative Symptoms, and Treatment Response in Psychiatric Patients Receiving Electroconvulsive Therapy (ECT)", aims to investigate clinical outcomes associated with different anesthetic agents used during ECT in patients diagnosed with Major Depressive Disorder (MDD) or Bipolar Depression. As these disorders constitute some of the most disabling psychiatric conditions globally, effective and timely treatment remains critical. Despite the widespread use of antidepressant medications, a substantial proportion of patients-particularly those classified under Treatment-Resistant Depression (TRD)-fail to achieve adequate remission. For such individuals, ECT continues to be one of the most reliable and evidence-based therapeutic options.
The study focuses on how anesthetic choice during ECT influences three key clinical parameters:
Depression severity, Suicidal ideation, and Dissociative symptoms. Ketamine, an NMDA receptor antagonist, has gained particular interest due to its rapid antidepressant properties and unique neurobiological profile. It has shown promise in reducing depressive symptoms more quickly than traditional anesthetic agents, although it may also trigger transient dissociative experiences. In contrast, propofol-another commonly used anesthetic during ECT-has more neutral sedative characteristics and lacks the rapid antidepressant effects attributed to ketamine. Understanding how these anesthetics influence clinical trajectories during ECT may help optimize treatment approaches for complex depressive disorders.
This non-interventional, prospective observational study will include 65 patients aged 18-65, all of whom meet DSM-5 criteria for MDD or Bipolar Disorder in a depressive episode and have an established clinical indication for ECT. Participants will be assigned naturally, based on clinical practice, to one of two groups:
Ketamine + Propofol anesthesia group (n=30) Propofol-only anesthesia group (n=35)
Researchers will not intervene in the anesthesia selection process. Instead, they will observe and measure clinical progress using validated psychiatric assessment tools:
Montgomery-Åsberg Depression Rating Scale (MADRS) for depression severity, Beck Suicidal Ideation Scale (BSI) for suicidal thoughts and planning, and Clinician-Administered Dissociative States Scale (CADSS) for dissociative symptoms such as depersonalization, derealization, and amnesia.
Assessments will be conducted at four time points to monitor the evolution of symptoms during treatment:
Before initiation of ECT, After the first ECT session, After the third ECT session, At the completion of the full ECT course. By comparing these clinical measurements across different anesthetic groups, the research seeks to determine whether ketamine offers measurable advantages in terms of speed of antidepressant response, reduction in suicidal thoughts, or increase in dissociative phenomena, compared with propofol. Prior studies have suggested that ketamine may produce faster mood improvement, especially in TRD, but may also lead to short-term cognitive and perceptual disturbances. This study will contribute real-world data from a psychiatric inpatient population undergoing standardized ECT procedures.
The expected outcome is a clearer understanding of how anesthetic choice influences the clinical course of patients undergoing ECT for depressive disorders. Such knowledge has the potential to guide personalized treatment strategies, optimize patient safety, and improve outcomes for individuals who have not responded to standard pharmacological interventions. Additionally, identifying dissociative responses linked specifically to ketamine may help clarify whi
- Being tested
- Electroconvulsive Therapy (ECT)
- Keywords
- Electroconvulsıve Therapy, ketamine, major depression, bipolar affective disorder, propofol
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT)Device
Also called Ketamine+propofol
Patients in this group receive a combination of Ketamine and Propofol as the anesthetic agent during their clinically indicated Electroconvulsive Therapy (ECT) sessions. The dosage and administration are determined by the clinical anesthesia team.
Electroconvulsive Therapy (ECT)Device
Also called Propofol
Patients in this group receive Propofol as the sole anesthetic agent during their clinically indicated Electroconvulsive Therapy (ECT) sessions. The dosage and administration are determined by the clinical anesthesia team.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Propofol Group | Group 1 (Ketamine+Propofol): Patients receiving a combination of Ketamine and Propofol as the anesthetic agent during ECT sessions. Receives: Device: Electroconvulsive Therapy (ECT) | |
| propofol group | Group 2 (Propofol): Patients receiving only Propofol as the anesthetic agent during ECT sessions. Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Severity (MADRS Score)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes. Each item is scored from 0 to 6, with a total score ranging from 0 to 60. Higher scores indicate more severe depression.
Measured: Periprocedural
Secondary outcomes (1)
Change in Suicidal Ideation (BSI Score)
The Beck Suicidal Ideation Scale (BSI) is a 19-item scale used to evaluate the intensity of suicidal thoughts and plans. Each item is scored from 0 to 2, with higher total scores indicating stronger suicidal ideation.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 May 2025
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurdan Sağbaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurdan Sağbaş, Pamukkale University
- Investigators
- ceyhan M şengül balcı, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463911
- Sponsor's protocol ID
- E-60116787-20-695838
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okamoto N, Nakai T, Sakamoto K, Nagafusa Y, Higuchi T, Nishikawa T. Rapid antidepressant effect of ketamine anesthesia during electroconvulsive therapy of treatment-resistant depression: comparing ketamine and propofol anesthesia. J ECT. 2010 Sep;26(3):223-7. doi: 10.1097/YCT.0b013e3181c3b0aa.
PubMed 19935085Liu Y, Yang J, Liu Y. Ketamine and electroconvulsive therapy for severe depression: A network meta-analysis of efficacy and safety. J Psychiatr Res. 2024 Jul;175:218-226. doi: 10.1016/j.jpsychires.2024.05.022. Epub 2024 May 11.
PubMed 38744161Zhang M, Rosenheck R, Lin X, Li Q, Zhou Y, Xiao Y, Huang X, Fan N, He H. A randomized clinical trial of adjunctive ketamine anesthesia in electro-convulsive therapy for depression. J Affect Disord. 2018 Feb;227:372-378. doi: 10.1016/j.jad.2017.11.034. Epub 2017 Nov 10.
PubMed 29149755
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Of Suıcıdal Ideatıon, Dıssocıactive Symptoms And Treatment Response In Psychıatrıc Patients Receıvıng Electroconvulsıve Therapy
- ClinicalTrials.gov ID
- NCT07463911
- Acronym / sponsor ID
- E-60116787-20-695838
- Keywords
- Electroconvulsıve Therapy, ketamine, major depression, bipolar affective disorder, propofol
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Nurdan SağbaşUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
Clarification Regarding Study Type: Observational
This study is a prospective, non-interventional observational study. The decision to administer Electroconvulsive Therapy (ECT) and the selection of the anesthetic agent (ketamine + propofol or propofol alone) are made entirely by the treating psychiatrist as part of routine clinical practice, independent of and prior to any research-related activities. Participants are not assigned to anesthetic groups by the investigators; rather, they are observed and grouped according to the anesthetic regimen already determined by their clinical team based on standard medical care. The investigators do not intervene in, alter, or influence the treatment process in any way. Data collection consists solely of administering validated psychiatric rating scales at predefined time points to monitor naturally occurring clinical outcomes. Therefore, this study meets the definition of an observational study as outlined in the Protocol Registration Data Element Definitions: participants receive interventions as part of routine medical care, and the researcher studies the effect of the intervention without assigning it.
Summary of the Study
This research project, titled "A Prospective Observational Study of Suicidal Ideation, Dissociative Symptoms, and Treatment Response in Psychiatric Patients Receiving Electroconvulsive Therapy (ECT)", aims to investigate clinical outcomes associated with different anesthetic agents used during ECT in patients diagnosed with Major Depressive Disorder (MDD) or Bipolar Depression. As these disorders constitute some of the most disabling psychiatric conditions globally, effective and timely treatment remains critical. Despite the widespread use of antidepressant medications, a substantial proportion of patients-particularly those classified under Treatment-Resistant Depression (TRD)-fail to achieve adequate remission. For such individuals, ECT continues to be one of the most reliable and evidence-based therapeutic options.
The study focuses on how anesthetic choice during ECT influences three key clinical parameters:
Depression severity, Suicidal ideation, and Dissociative symptoms. Ketamine, an NMDA receptor antagonist, has gained particular interest due to its rapid antidepressant properties and unique neurobiological profile. It has shown promise in reducing depressive symptoms more quickly than traditional anesthetic agents, although it may also trigger transient dissociative experiences. In contrast, propofol-another commonly used anesthetic during ECT-has more neutral sedative characteristics and lacks the rapid antidepressant effects attributed to ketamine. Understanding how these anesthetics influence clinical trajectories during ECT may help optimize treatment approaches for complex depressive disorders.
This non-interventional, prospective observational study will include 65 patients aged 18-65, all of whom meet DSM-5 criteria for MDD or Bipolar Disorder in a depressive episode and have an established clinical indication for ECT. Participants will be assigned naturally, based on clinical practice, to one of two groups:
Ketamine + Propofol anesthesia group (n=30) Propofol-only anesthesia group (n=35)
Researchers will not intervene in the anesthesia selection process. Instead, they will observe and measure clinical progress using validated psychiatric assessment tools:
Montgomery-Åsberg Depression Rating Scale (MADRS) for depression severity, Beck Suicidal Ideation Scale (BSI) for suicidal thoughts and planning, and Clinician-Administered Dissociative States Scale (CADSS) for dissociative symptoms such as depersonalization, derealization, and amnesia.
Assessments will be conducted at four time points to monitor the evolution of symptoms during treatment:
Before initiation of ECT, After the first ECT session, After the third ECT session, At the completion of the full ECT course. By comparing these clinical measurements across different anesthetic groups, the research seeks to determine whether ketamine offers measurable advantages in terms of speed of antidepressant response, reduction in suicidal thoughts, or increase in dissociative phenomena, compared with propofol. Prior studies have suggested that ketamine may produce faster mood improvement, especially in TRD, but may also lead to short-term cognitive and perceptual disturbances. This study will contribute real-world data from a psychiatric inpatient population undergoing standardized ECT procedures.
The expected outcome is a clearer understanding of how anesthetic choice influences the clinical course of patients undergoing ECT for depressive disorders. Such knowledge has the potential to guide personalized treatment strategies, optimize patient safety, and improve outcomes for individuals who have not responded to standard pharmacological interventions. Additionally, identifying dissociative responses linked specifically to ketamine may help clarify whi
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Propofol Group | – | Device: Electroconvulsive Therapy (ECT)Group 1 (Ketamine+Propofol): Patients receiving a combination of Ketamine and Propofol as the anesthetic agent during ECT sessions. |
| propofol group | – | Device: Electroconvulsive Therapy (ECT)Group 2 (Propofol): Patients receiving only Propofol as the anesthetic agent during ECT sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Being an inpatient at Pamukkale University Faculty of Medicine, Department of Mental Health and Diseases Hospital
Key inclusion criteria (2 listed)
- Diagnosed with depression or bipolar depression according to DSM-5
- Having an indication for ECT (Electroconvulsive Therapy)
Key exclusion criteria (5 listed)
- Mental limitations such as intellectual disability
- Refusal to undergo ECT
- Patients not suitable for general anesthesia
- Substance use disorder
- Alcohol dependence
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 |
|---|---|---|
| Electroconvulsive Therapy (ECT)Also: Ketamine+propofolPatients in this group receive a combination of Ketamine and Propofol as the anesthetic agent during their clinically indicated Electroconvulsive Therapy (ECT) sessions. The dosage and administration are determined by the clinical anesthesia team. | Device | Ketamine + Propofol Group |
| Electroconvulsive Therapy (ECT)Also: PropofolPatients in this group receive Propofol as the sole anesthetic agent during their clinically indicated Electroconvulsive Therapy (ECT) sessions. The dosage and administration are determined by the clinical anesthesia team. | Device | propofol group |
Primary outcome
Change in Depression Severity (MADRS Score)
Time frame: Periprocedural
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes. Each item is scored from 0 to 6, with a total score ranging from 0 to 60. Higher scores indicate more severe depression.
1 secondary outcome
Change in Suicidal Ideation (BSI Score)
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 19935085Okamoto N, Nakai T, Sakamoto K, Nagafusa Y, Higuchi T, Nishikawa T. Rapid antidepressant effect of ketamine anesthesia during electroconvulsive therapy of treatment-resistant depression: comparing ketamine and propofol anesthesia. J ECT. 2010 Sep;26(3):223-7. doi: 10.1097/YCT.0b013e3181c3b0aa.
- Background: PubMed 38744161Liu Y, Yang J, Liu Y. Ketamine and electroconvulsive therapy for severe depression: A network meta-analysis of efficacy and safety. J Psychiatr Res. 2024 Jul;175:218-226. doi: 10.1016/j.jpsychires.2024.05.022. Epub 2024 May 11.
- Background: PubMed 29149755Zhang M, Rosenheck R, Lin X, Li Q, Zhou Y, Xiao Y, Huang X, Fan N, He H. A randomized clinical trial of adjunctive ketamine anesthesia in electro-convulsive therapy for depression. J Affect Disord. 2018 Feb;227:372-378. doi: 10.1016/j.jad.2017.11.034. Epub 2017 Nov 10.
- Individual participant dataSharing planned: Undecided
Related trials for Major Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
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.
ceyhan M şengül balcı principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Bipolar Affective Disorder, run by Nurdan Sağbaş at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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 in Depression Severity (MADRS Score) (time frame: Periprocedural). 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 NCT07463911, which also lists 3 linked publications.
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 13 Mar 2026.