Electroconvulsive TherapyNCT07526454
Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder
A study testing Electroconvulsive Therapy and Ketamine in people with Electroconvulsive Therapy and Intravenous Ketamine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Electroconvulsive Therapy, Intravenous Ketamine, Treatment-Resistant
- What is being tested?
- Electroconvulsive Therapy and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years.
- Current diagnosis of major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Treatment resistance defined as failure to respond to ≥2 adequate antidepressant trials in the current episode.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20.
- Capacity to provide informed consent.
Who cannot join
- History of psychotic disorders or bipolar disorder.
- Current substance use disorder.
- Significant neurological disorders or traumatic brain injury.
- Uncontrolled hyper- tension.
- cardiovascular diseases in the past six months.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder
This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD).
Read the detailed description
Treatment resistant depression is defined as a lack of adequate response to at least two antidepressant trials of sufficient dose, duration, and adherence in the current depressive episode.
Recent studies estimate treatment-resistant depression (TRD) by 30% of people with major depressive disorder (MDD) leading to significant challenges in care. This condition can increase disability, healthcare costs, and suicide risk, making effective treatments crucial.
- Conditions
- Electroconvulsive Therapy, Intravenous Ketamine, Treatment-Resistant, Major Depressive Disorder
- Being tested
- Electroconvulsive Therapy, Ketamine
- 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.
Electroconvulsive TherapyDrug
Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).
KetamineDrug
Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| ECT Group | Experimental | Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks). Receives: Drug: Electroconvulsive Therapy |
| Ketamine Group | Active comparator | Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks). Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) was recorded from baseline to end of 3-week treatment period. The MADRS comprises the following 10 items: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. With a, maximum score of 60, where higher scores indicate greater severity
Measured: 3 weeks post-procedure
Secondary outcomes (2)
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) for cognitive function was recorded from baseline to end of 3-week treatment period. MoCA is a rapid, 10-15 minute screening tool used to detect mild cognitive impairment (MCI) and early dementia, scoring a maximum of 30 points, with a score of 26 or higher considered normal.
Measured: 3 weeks post-procedure
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-administered diagnostic tool used by clinicians to screen for the presence and severity of depression. It assesses symptoms over the past two weeks based on DSM-IV criteria, with scores ranging from 0 to 27, where higher scores indicate greater depression severity.
Measured: 3 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive TherapyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed ElNeanay, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526454
- Sponsor's protocol ID
- 36264PR1275/7/25
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07526454
- Acronym / sponsor ID
- 36264PR1275/7/25
- Conditions
- Electroconvulsive Therapy, Intravenous Ketamine, Treatment-Resistant, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 13 Apr 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.
This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD).
Detailed description
Treatment resistant depression is defined as a lack of adequate response to at least two antidepressant trials of sufficient dose, duration, and adherence in the current depressive episode.
Recent studies estimate treatment-resistant depression (TRD) by 30% of people with major depressive disorder (MDD) leading to significant challenges in care. This condition can increase disability, healthcare costs, and suicide risk, making effective treatments crucial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT Group | Experimental | Drug: Electroconvulsive TherapyPatients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks). |
| Ketamine Group | Active comparator | Drug: KetaminePatients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-75 years.
- Current diagnosis of major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Treatment resistance defined as failure to respond to ≥2 adequate antidepressant trials in the current episode.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20.
- Capacity to provide informed consent.
Key exclusion criteria (6 listed)
- History of psychotic disorders or bipolar disorder.
- Current substance use disorder.
- Significant neurological disorders or traumatic brain injury.
- Uncontrolled hyper- tension.
- cardiovascular diseases in the past six months.
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 TherapyPatients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks). | Drug | ECT Group |
| KetaminePatients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks). | Drug | Ketamine Group |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale
Time frame: 3 weeks post-procedure
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) was recorded from baseline to end of 3-week treatment period. The MADRS comprises the following 10 items: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. With a, maximum score of 60, where higher scores indicate greater severity
2 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 3 weeks post-procedure
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 weeks post-procedure
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy and Ketamine in people with Electroconvulsive Therapy and Intravenous Ketamine, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 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 13 Apr 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 Egypt. 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?
Change in Montgomery-Åsberg Depression Rating Scale (time frame: 3 weeks post-procedure). 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 13 Apr 2026.