Major Depressive DisorderEarly Phase 1LTP-DUCIECTNCT06733558
Long-term Potentiation Disruption Underlying Cognitive Impairment in ECT
A Early Phase 1 study testing Electroconvulsive Therapy in people with Major Depressive Disorder and Bipolar Disorder II, run by University of New Mexico at 1 site in United States.
Trial summary
Cognitive problems, like memory loss, are common after brain injuries like trauma or stroke. These problems make daily life harder, and the investigators don't yet know the best ways to help the brain recover. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder II
- What is being tested?
- Electroconvulsive Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to Jul 2026
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of major depressive disorder (MDD; with or without psychotic features) or bipolar 2 most recent episode depressed;
- clinical indications for ECT with right unilateral electrode placement including treatment resistance or a need for a rapid and definitive response,
- age range adults 18-85 years, and
- English-speaking (many of the neuropsychological tests are only available in English). Antidepressant medications will be continued as clinically indicated. To maintain feasibility and retention, as needed medications will be permitted for anxiety and insomnia.
Who cannot join
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease);
- other psychiatric conditions (e.g., schizophrenia, bipolar I disorder);
- current drug or alcohol use disorder (except for nicotine);
- prisoners; and
- pregnancy (pre- menopausal participants will receive pregnancy test, which is clinically indicated for ECT and not part of study protocol).
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive problems, like memory loss, are common after brain injuries like trauma or stroke. These problems make daily life harder, and the investigators don't yet know the best ways to help the brain recover. Scientists think that a process in the brain called long-term potentiation (LTP) is important for memory and learning. When LTP isn't working properly, it may cause problems with thinking and memory. But studying LTP in people is hard because it happens deep inside the brain.
Our research uses a treatment called electroconvulsive therapy (ECT) to better understand LTP. ECT is a treatment for severe depression that works by causing a controlled seizure in the brain. While ECT often helps depression, it can temporarily cause memory and thinking problems, which usually improve over time. This makes ECT a good way to study how thinking and memory recover.
Read more
The investigators will use a tool called electroencephalography (EEG) to measure brain activity during different stages of ECT treatment. EEG is a safe and non-invasive way to track changes in LTP. Specifically, the investigators will measure how the brain responds to visual signals using something called visual evoked potentials (VEPs). These signals can show how LTP is affected by ECT.
The study's main goal is to track changes in LTP using VEPs during and after ECT. By studying these changes, the investigators hope to learn how ECT affects the brain and how it recovers. This could help improve treatments for brain injuries and other conditions that cause memory and thinking problems.
Read the detailed description
This study aims to investigate changes in long-term potentiation (LTP)-like phenomena using visual evoked potentials (VEPs) in patients undergoing electroconvulsive therapy (ECT) for treatment-resistant depression. LTP is a fundamental neurophysiological process involved in synaptic plasticity and memory formation, and its disruption has been proposed as a potential mechanism underlying the cognitive side effects of ECT.
Study Design:
The study employs a paired pre- and post-intervention design. VEPs will be recorded using electroencephalography (EEG) at two time points:
Pre-ECT: Prior to the initiation of the ECT treatment series. Post-ECT: Immediately following the completion of the ECT series. The VEP paradigm consists of repetitive visual stimulation presented on a computer monitor. The primary outcome is the amplitude of the N1 component of the VEP, a negative deflection occurring approximately 100 milliseconds after stimulus onset, which is sensitive to changes in LTP-like synaptic plasticity.
Methodology:
Participants will undergo EEG sessions using a high-density EEG system with either a 64-lead cap. Visual stimuli will be presented in a controlled environment to elicit VEPs, and the data will be analyzed to assess changes in the N1 component amplitude between the pre- and post-ECT recordings.
Analysis:
A paired t-test will be used to compare N1 amplitudes before and after the ECT series to evaluate the hypothesis that ECT disrupts LTP-like phenomena, as reflected by changes in VEPs.
This study provides a novel application of VEPs to investigate the neurophysiological effects of ECT and aims to enhance our understanding of synaptic plasticity in the context of therapeutic brain stimulation. Findings from this research could inform future strategies to mitigate the side effects of ECT while preserving its clinical efficacy.
- Conditions
- Major Depressive Disorder, Bipolar Disorder II
- Being tested
- Electroconvulsive Therapy
- Keywords
- electroconvulsive therapy, brain recovery, major depressive disorder, long-term potentiation, cognitive impairment, bipolar disorder, type II
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyProcedure or surgery
Electroconvulsive therapy (ECT) is a medical treatment that uses controlled electrical stimulation to induce a brief, generalized seizure in the brain. This intervention is performed under general anesthesia with muscle relaxants to ensure patient comfort and safety. ECT is typically used to treat severe depression, bipolar disorder, and other mental health conditions when other treatments, such as medication and psychotherapy, have not been effective.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing ECT | Experimental | Participants undergoing ECT for depressive episode Receives: Procedure: Electroconvulsive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Evoked Potential
The primary outcome of this study is to measure changes in long-term potentiation (LTP)-like phenomena using visual evoked potentials (VEPs), a non-invasive marker of brain activity recorded through electroencephalography (EEG). VEPs are brain responses to visual stimuli, and the N1 component, a negative peak occurring approximately 100 milliseconds after the stimulus, serves as a reliable index of LTP-like phenomena in humans.
In this study, participants will undergo a visual stimulation paradigm designed to elicit and measure changes in the amplitude of the N1 component. This approach allows us to assess changes in synaptic plasticity (a key feature of LTP) before, during, and after a series of electroconvulsive therapy (ECT) treatments. These measurements will be correlated with cognitive performance and memory changes to explore the relationship between ECT-induced cognitive effects and LTP disruption.
Measured: From enrollment to eight weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start21 Jan 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: NIGMS, the funding agency, does not consider this study a clinical trial and they asked to remove from the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be only one group that will be studied, those undergoing ECT.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733558
- Sponsor's protocol ID
- 23-286
- Other IDs
- 5P20GM109089-10
- Acronym
- LTP-DUCIECT
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) is currently undecided. While the study aims to contribute to scientific knowledge and improve understanding of electroconvulsive therapy (ECT)-associated cognitive impairment, logistical and regulatory considerations regarding data de-identification, storage, and sharing policies are still under review. The research team is evaluating whether sharing IPD, such as de-identified EEG data and cognitive performance results, would align with institutional guidelines and participant consent. Updates on the IPD sharing decision will be provided upon final determination.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Potentiation Disruption Underlying Cognitive Impairment in ECT
- ClinicalTrials.gov ID
- NCT06733558
- Acronym / sponsor ID
- LTP-DUCIECT / 23-286
- Conditions
- Major Depressive Disorder, Bipolar Disorder II
- Keywords
- electroconvulsive therapy, brain recovery, major depressive disorder, long-term potentiation, cognitive impairment, bipolar disorder, type II
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NIGMS, the funding agency, does not consider this study a clinical trial and they asked to remove from the system.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Dec 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.
Cognitive problems, like memory loss, are common after brain injuries like trauma or stroke. These problems make daily life harder, and the investigators don't yet know the best ways to help the brain recover. Scientists think that a process in the brain called long-term potentiation (LTP) is important for memory and learning. When LTP isn't working properly, it may cause problems with thinking and memory. But studying LTP in people is hard because it happens deep inside the brain.
Our research uses a treatment called electroconvulsive therapy (ECT) to better understand LTP. ECT is a treatment for severe depression that works by causing a controlled seizure in the brain. While ECT often helps depression, it can temporarily cause memory and thinking problems, which usually improve over time. This makes ECT a good way to study how thinking and memory recover.
The investigators will use a tool called electroencephalography (EEG) to measure brain activity during different stages of ECT treatment. EEG is a safe and non-invasive way to track changes in LTP. Specifically, the investigators will measure how the brain responds to visual signals using something called visual evoked potentials (VEPs). These signals can show how LTP is affected by ECT.
The study's main goal is to track changes in LTP using VEPs during and after ECT. By studying these changes, the investigators hope to learn how ECT affects the brain and how it recovers. This could help improve treatments for brain injuries and other conditions that cause memory and thinking problems.
Detailed description
This study aims to investigate changes in long-term potentiation (LTP)-like phenomena using visual evoked potentials (VEPs) in patients undergoing electroconvulsive therapy (ECT) for treatment-resistant depression. LTP is a fundamental neurophysiological process involved in synaptic plasticity and memory formation, and its disruption has been proposed as a potential mechanism underlying the cognitive side effects of ECT.
Study Design:
The study employs a paired pre- and post-intervention design. VEPs will be recorded using electroencephalography (EEG) at two time points:
Pre-ECT: Prior to the initiation of the ECT treatment series. Post-ECT: Immediately following the completion of the ECT series. The VEP paradigm consists of repetitive visual stimulation presented on a computer monitor. The primary outcome is the amplitude of the N1 component of the VEP, a negative deflection occurring approximately 100 milliseconds after stimulus onset, which is sensitive to changes in LTP-like synaptic plasticity.
Methodology:
Participants will undergo EEG sessions using a high-density EEG system with either a 64-lead cap. Visual stimuli will be presented in a controlled environment to elicit VEPs, and the data will be analyzed to assess changes in the N1 component amplitude between the pre- and post-ECT recordings.
Analysis:
A paired t-test will be used to compare N1 amplitudes before and after the ECT series to evaluate the hypothesis that ECT disrupts LTP-like phenomena, as reflected by changes in VEPs.
This study provides a novel application of VEPs to investigate the neurophysiological effects of ECT and aims to enhance our understanding of synaptic plasticity in the context of therapeutic brain stimulation. Findings from this research could inform future strategies to mitigate the side effects of ECT while preserving its clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be only one group that will be studied, those undergoing ECT.
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing ECT | Experimental | Procedure: Electroconvulsive TherapyParticipants undergoing ECT for depressive episode |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of major depressive disorder (MDD; with or without psychotic features) or bipolar 2 most recent episode depressed;
- clinical indications for ECT with right unilateral electrode placement including treatment resistance or a need for a rapid and definitive response,
- age range adults 18-85 years, and
- English-speaking (many of the neuropsychological tests are only available in English). Antidepressant medications will be continued as clinically indicated. To maintain feasibility and retention, as needed medications will be permitted for anxiety and insomnia.
Key exclusion criteria (5 listed)
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease);
- other psychiatric conditions (e.g., schizophrenia, bipolar I disorder);
- current drug or alcohol use disorder (except for nicotine);
- prisoners; and
- pregnancy (pre- menopausal participants will receive pregnancy test, which is clinically indicated for ECT and not part of study protocol).
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 TherapyElectroconvulsive therapy (ECT) is a medical treatment that uses controlled electrical stimulation to induce a brief, generalized seizure in the brain. This intervention is performed under general anesthesia with muscle relaxants to ensure patient comfort and safety. ECT is typically used to treat severe depression, bipolar disorder, and other mental health conditions when other treatments, such as medication and psychotherapy, have not been effective. | Procedure or surgery | Participants undergoing ECT |
Primary outcome
Visual Evoked Potential
Time frame: From enrollment to eight weeks after enrollment
The primary outcome of this study is to measure changes in long-term potentiation (LTP)-like phenomena using visual evoked potentials (VEPs), a non-invasive marker of brain activity recorded through electroencephalography (EEG). VEPs are brain responses to visual stimuli, and the N1 component, a negative peak occurring approximately 100 milliseconds after the stimulus, serves as a reliable index of LTP-like phenomena in humans. In this study, participants will undergo a visual stimulation paradigm designed to elicit and measure changes in the amplitude of the N1 component. This approach allows us to assess changes in synaptic plasticity (a key feature of LTP) before, during, and after a series of electroconvulsive therapy (ECT) treatments. These measurements will be correlated with cognitive performance and memory changes to explore the relationship between ECT-induced cognitive effects and LTP disruption.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) is currently undecided. While the study aims to contribute to scientific knowledge and improve understanding of electroconvulsive therapy (ECT)-associated cognitive impairment, logistical and regulatory considerations regarding data de-identification, storage, and sharing policies are still under review. The research team is evaluating whether sharing IPD, such as de-identified EEG data and cognitive performance results, would align with institutional guidelines and participant consent. Updates on the IPD sharing decision will be provided upon final determination.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
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 Early Phase 1 study testing Electroconvulsive Therapy in people with Major Depressive Disorder and Bipolar Disorder II, run by University of New Mexico at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 21 Jan 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Visual Evoked Potential (time frame: From enrollment to eight weeks after enrollment). 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 21 Jan 2026.