Treatment Response In ECT Patients

March 11, 2026 updated by: Nurdan Sağbaş

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.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Being an inpatient at Pamukkale University Faculty of Medicine, Department of Mental Health and Diseases Hospital

Description

Inclusion Criteria:

  1. Diagnosed with depression or bipolar depression according to DSM-5
  2. Having an indication for ECT (Electroconvulsive Therapy)

Exclusion Criteria:

  1. Mental limitations such as intellectual disability
  2. Refusal to undergo ECT
  3. Patients not suitable for general anesthesia
  4. Substance use disorder
  5. Alcohol dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ketamine + Propofol Group
Group 1 (Ketamine+Propofol): Patients receiving a combination of Ketamine and Propofol as the anesthetic agent during ECT sessions.
Device: Electroconvulsive Therapy (ECT)
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.
Other Names:
  • Ketamine+propofol
Device: Electroconvulsive Therapy (ECT)
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.
Other Names:
  • Propofol
propofol group
Group 2 (Propofol): Patients receiving only Propofol as the anesthetic agent during ECT sessions.
Device: Electroconvulsive Therapy (ECT)
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.
Other Names:
  • Ketamine+propofol
Device: Electroconvulsive Therapy (ECT)
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.
Other Names:
  • Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Suicidal Ideation (BSI Score)
Time Frame: Periprocedural
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.
Periprocedural

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Dissociative Symptoms (CADSS Score)
Time Frame: Periprocedural
The Clinician-Administered Dissociative States Scale (CADSS) is a 19-item scale used to measure transient dissociative states (amnesia, depersonalization, and derealization). Each item is rated from 0 (not at all) to 4 (extremely). Higher scores indicate more severe dissociative symptoms.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nurdan Sağbaş

Investigators

  • Principal Investigator: ceyhan M şengül balcı, Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-60116787-20-695838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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