DepressionRCC2NCT02761330
Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia
A study testing Ketamine and Electroconvulsive Therapy in people with Depression and Delirium, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Delirium, Seizures
- What is being tested?
- Ketamine and Electroconvulsive Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Treatment resistant depression requiring outpatient ECT
- Planned right unilateral ECT stimulation
- English speaking
- Able to provide written informed consent
Who cannot join
- Known brain lesion or neurological illness that causes cognitive impairment
- Schizophrenia
- Schizoaffective disorder
- Blindness or deafness or motor impediments that may impair performance for cognitive testing battery
- Inadequate ECT seizure duration with etomidate
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia Reconstitution of Consciousness and Cognition (Phase 2)
This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.
Read the detailed description
Seizures are often associated with loss of consciousness, possibly through effects on sub-cortical arousal systems, disruption of cortical-subcortical interactions, and ultimately through depressed neocortical function. Furthermore, people are often confused in the post-ictal state even when consciousness returns after a seizure. Disrupted cognitive function during the postictal phase has not been fully characterized but presents short and long-term implications. Many experience an acute disorder of attention, consciousness, and cognition, referred to as delirium. Memory deficits are also common. The neurobiology for these phenomena are incomplete and challenging to test, as seizures are typically sporadic and vary in intensity and character. In contrast, the setting of electroconvulsive therapy (ECT) provides the opportunity to study the reconstitution of consciousness and cognition following seizures in an elective and predictable context.
There is no standard agent used to induce general anesthesia during ECT. Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery. Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate, a commonly used anesthetic for general anesthesia during ECT.
The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia. Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial. Each patient will complete seven study visits. The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia. After this session, patients will be randomized to three sessions each week for two weeks (six treatments total). Over the first week patients will be randomized in order for three treatment arms: (1) etomidate general anesthesia and ECT, (2) ketamine general anesthesia and ECT, and (3) ketamine alone. Patients will be blinded to the treatment arm for each session. Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions.
Patients that agree will have a MRI.
- Conditions
- Depression, Delirium, Seizures, Cognitive Disorders
- Being tested
- Ketamine, Electroconvulsive Therapy
- Keywords
- Anesthesia, Electroconvulsive therapy, Delirium, Electroencephalography, Seizures, Depression, Ketamine, Etomidate, Physiological Effects of Drugs, Pharmacologic Actions, Confusion, Mental Disorders, Neurobehavioral Manifestations, Signs and Symptoms, Neurologic Manifestations, Cognitive Disorders
- Medical subject headings
- Depression, Delirium, Seizures, Cognitive Dysfunction, Confusion, Mental Disorders, Neurobehavioral Manifestations, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.
Electroconvulsive TherapyProcedure or surgery
Also called ECT
Dose of the ECT charge will be determined during titration session prior to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate + ECT | Active comparator | General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. Receives: Procedure: Electroconvulsive Therapy |
| Ketamine + ECT | Experimental | General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. Receives: Drug: Ketamine; Procedure: Electroconvulsive Therapy |
| Ketamine alone | Sham comparator | General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function During Recovery: Rate of Recovery
A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses.
Cognition Test Battery:
- Psychomotor Vigilance Task (PVT)
- Digital Symbol Substitution Task (DSST)
- Motor Praxis Task (MP)
- Visual Object Learning Task (VOLT)
- Abstract Matching (AM)
Rate of Recovery for this measure is defined as the time (in inverse hours) for participants to return to their baseline performance for each task.
Measured: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
Change in Cognitive Function During Recovery: Initial Decrement
A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses.
Cognition Test Battery:
- Psychomotor Vigilance Task (PVT)
- Digital Symbol Substitution Task (DSST)
- Motor Praxis Task (MP)
- Visual Object Learning Task (VOLT)
- Abstract Matching (AM)
Initial Decrement for this measure is defined as the difference between response times (in seconds) at baseline and t=0 for each task.
Measured: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
Secondary outcomes (14)
Delirium Incidence and Severity
Assessed using 3D Confusion Assessment Method (CAM).
The groups/arms for this outcome are separated by anesthetic regimen; however, due to the crossover design of this study all participants are included in analyses for each group.
Measured: Immediately following return of consciousness (t=0) during treatment days 1-6.
Suicidality
The groups/arms for this outcome are combined as a whole-group analysis due to the crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. All participants included in analyses completed all treatments, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in suicidality from baseline to treatment 6 based on the Scale of Suicide Ideation.
The measure completed was the Scale of Suicide Ideation. For this study, participants completed the following questions of the questionnaire:
- wish to live (0 Moderate to Strong, 1 Weak, 2 None)
- wish to die (0 None, 1 Weak, 2 Moderate to Strong)
The total scores range from 0-4. Lower scores indicate high suicide ideation, and high scores indicate low suicide ideation.
Measured: assessed at baseline on treatment days 1-6.
ECT Seizure Duration
Duration (in seconds) of seizure induced by ECT treatment
Measured: up to days 1-6
ECT Electrical Dose
The electrical dose necessary for seizure induction is determined during a dose-charge titration session prior to participant randomization and session 1. These results report the average electrical dose across all participants for the first treatment session during Treatment Week 1.
The range for these data is 0 - 100% electrical charge.
Measured: First ECT treatment session during Treatment Week 1
Subjective Assessment of Whether ECT Was Performed, Determined by Asking the Patient.
To assess patient blinding of treatment performed, the patient will be asked: "Based on how you feel, did you have ECT today?"
Results indicate participants correctly answering the subjective assessment.
Measured: Assessed at 120 minutes after return of responsiveness on treatment days 1-6
Change in Mood Assessed Using the Mood Self-Assessment Manikin
Mood Self-Assessment Manikin (SAM) Scale: 1 (very unpleasant) - 9 (very pleasant).
The groups/arms for this outcome are combined as a whole-group analysis due to the Crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. Further, any statistical analyses would be underpowered due to low participant numbers in each arm. Thus, the results are combined and reported as a whole group analysis. All participants included in analyses completed all treatments included in the study, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in mood from baseline to treatment 6 based on the SAM. Additionally, data collected at baseline are not dependent on the study group/arm.
Measured: baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Average Change in Mood Based on the Depression PROMIS-CAT
PROMIS-CAT (Patient Reported Outcomes Measurement Information System-Computer Adaptive Testing) for depression
The groups/arms for this outcome are combined as a whole-group analysis due to the Crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. Further, any statistical analyses would be underpowered due to low participant numbers in each arm. Thus, the results are combined and reported as a whole group analysis. All participants included in analyses completed all treatments included in the study, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in mood from baseline to treatment 6 based on the PROMIS-CAT. Additionally, data collected at baseline are not dependent on the study group/arm.
Measured: baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Change in Delta Band (0.5-4 Hz) Relative Power in the Scale EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the delta band over the sum of total power between 0.5 - 70Hz.
Measured: baseline, post-ECT from 0-120 minutes
Change in Theta Band (4-8 Hz) Relative Power in the Scalp EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the theta band over the sum of total power between 0.5 - 70Hz.
Measured: baseline, post-ECT from 0-120 minutes
Change in Alpha Band (8-13 Hz) Power in the Scalp EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the alpha band over the sum of total power between 0.5 - 70Hz.
Measured: baseline, post-ECT from 0-120 minutes
Change in Beta Band (13-20 Hz) Relative Power in the Scalp EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the beta band over the sum of total power between 0.5 - 70Hz.
Measured: baseline, post-ECT from 0-120 minutes
Change in Anterior-Posterior Functional Connectivity in the Scalp During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the coherence measure, which is used for tracking changes in anterior-posterior functional connectivity.
Coherence is a measure of synchronization between two signals which is used to measure anterior-posterior functional connectivity. Coherence is a unitless measure between 0 and 1. High coherence between time-series of two neural populations reflects higher efficiency in communication between those populations and therefore stronger functional connectivity.
Measured: baseline, post-ECT from 0-120 minutes
Change in Anterior-Posterior Phase-lag in the Scalp EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Phase-lag was assessed using the Phase-Lag Index (PLI), a measure ranging from 0 - 1. A consistent phase-lag between two tim-series results in a PLI of 1. A time-series without coupling results in a PLI near or equaling 0. Results show the difference in anterior-posterior PLI between baseline and post-ECT.
Measured: baseline, post-ECT from 0 -120 minutes
Change in EEG Entropy in the Scalp EEG During Recovery
High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as permutation entropy (PE) measures in posterior regions, which we are using to track changes in scalp EEG entropy.
Permutation Entropy (PE) is a measure that is used to quantify the complexity of time series signals. It is a unitless measure between 0 and 1. Lower the PE represents a more regular and more deterministic time series while higher PE represents a more complex time series.
Measured: baseline, Post-ECT from 0 -120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- James S McDonnell Foundation
- Responsible party
- Principal investigator, Ben Palanca, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761330
- Sponsor's protocol ID
- 201512110
- Acronym
- RCC2
- Status last verified
- Jun 2021
- First submitted
- 30 Apr 2016
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hickman LB, Kafashan M, Labonte AK, Chan CW, Huels ER, Guay CS, Guan MJ, Ching S, Lenze EJ, Farber NB, Avidan MS, Hogan RE, Palanca BJA. Postictal generalized electroencephalographic suppression following electroconvulsive therapy: Temporal characteristics and impact of anesthetic regimen. Clin Neurophysiol. 2021 Apr;132(4):977-983. doi: 10.1016/j.clinph.2020.12.018. Epub 2021 Jan 28.
PubMed 33652270Hickman LB, Hogan RE, Labonte AK, Kafashan M, Chan CW, Huels ER, Ching S, Lenze EJ, Maccotta L, Eisenman LN, Keith Day B, Farber NB, Avidan MS, Palanca BJA. Voltage-based automated detection of postictal generalized electroencephalographic suppression: Algorithm development and validation. Clin Neurophysiol. 2020 Dec;131(12):2817-2825. doi: 10.1016/j.clinph.2020.08.015. Epub 2020 Sep 11.
PubMed 33137572Palanca BJA, Maybrier HR, Mickle AM, Farber NB, Hogan RE, Trammel ER, Spencer JW, Bohnenkamp DD, Wildes TS, Ching S, Lenze E, Basner M, Kelz MB, Avidan MS. Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol. Front Psychiatry. 2018 May 14;9:171. doi: 10.3389/fpsyt.2018.00171. eCollection 2018.
PubMed 29867602
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia Reconstitution of Consciousness and Cognition (Phase 2)
- ClinicalTrials.gov ID
- NCT02761330
- Acronym / sponsor ID
- RCC2 / 201512110
- Conditions
- Depression, Delirium, Seizures, Cognitive Disorders
- Keywords
- Anesthesia, Electroconvulsive therapy, Delirium, Electroencephalography, Seizures, Depression, Ketamine, Etomidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- James S McDonnell Foundation
- Study start
- Apr 2016 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Posted 28 Jun 2021
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 geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.
Detailed description
Seizures are often associated with loss of consciousness, possibly through effects on sub-cortical arousal systems, disruption of cortical-subcortical interactions, and ultimately through depressed neocortical function. Furthermore, people are often confused in the post-ictal state even when consciousness returns after a seizure. Disrupted cognitive function during the postictal phase has not been fully characterized but presents short and long-term implications. Many experience an acute disorder of attention, consciousness, and cognition, referred to as delirium. Memory deficits are also common. The neurobiology for these phenomena are incomplete and challenging to test, as seizures are typically sporadic and vary in intensity and character. In contrast, the setting of electroconvulsive therapy (ECT) provides the opportunity to study the reconstitution of consciousness and cognition following seizures in an elective and predictable context.
There is no standard agent used to induce general anesthesia during ECT. Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery. Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate, a commonly used anesthetic for general anesthesia during ECT.
The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia. Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial. Each patient will complete seven study visits. The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia. After this session, patients will be randomized to three sessions each week for two weeks (six treatments total). Over the first week patients will be randomized in order for three treatment arms: (1) etomidate general anesthesia and ECT, (2) ketamine general anesthesia and ECT, and (3) ketamine alone. Patients will be blinded to the treatment arm for each session. Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions.
Patients that agree will have a MRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etomidate + ECT | Active comparator | Procedure: Electroconvulsive TherapyGeneral anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. |
| Ketamine + ECT | Experimental | Drug: Ketamine, Procedure: Electroconvulsive TherapyGeneral anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. |
| Ketamine alone | Sham comparator | Drug: KetamineGeneral anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Treatment resistant depression requiring outpatient ECT
- Planned right unilateral ECT stimulation
- English speaking
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Known brain lesion or neurological illness that causes cognitive impairment
- Schizophrenia
- Schizoaffective disorder
- Blindness or deafness or motor impediments that may impair performance for cognitive testing battery
- Inadequate ECT seizure duration with etomidate
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 |
|---|---|---|
| KetamineKetamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg. | Drug | Ketamine + ECT, Ketamine alone |
| Electroconvulsive TherapyAlso: ECTDose of the ECT charge will be determined during titration session prior to randomization. | Procedure or surgery | Etomidate + ECT, Ketamine + ECT |
Primary outcome
Change in Cognitive Function During Recovery: Rate of Recovery
Time frame: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses. Cognition Test Battery: * Psychomotor Vigilance Task (PVT) * Digital Symbol Substitution Task (DSST) * Motor Praxis Task (MP) * Visual Object Learning Task (VOLT) * Abstract Matching (AM) Rate of Recovery for this measure is defined as the time (in inverse hours) for participants to return to their baseline performance for each task.
Change in Cognitive Function During Recovery: Initial Decrement
Time frame: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses. Cognition Test Battery: * Psychomotor Vigilance Task (PVT) * Digital Symbol Substitution Task (DSST) * Motor Praxis Task (MP) * Visual Object Learning Task (VOLT) * Abstract Matching (AM) Initial Decrement for this measure is defined as the difference between response times (in seconds) at baseline and t=0 for each task.
14 secondary outcomes
Delirium Incidence and Severity
Time frame: Immediately following return of consciousness (t=0) during treatment days 1-6.
Suicidality
Time frame: assessed at baseline on treatment days 1-6.
ECT Seizure Duration
Time frame: up to days 1-6
ECT Electrical Dose
Time frame: First ECT treatment session during Treatment Week 1
Subjective Assessment of Whether ECT Was Performed, Determined by Asking the Patient.
Time frame: Assessed at 120 minutes after return of responsiveness on treatment days 1-6
Change in Mood Assessed Using the Mood Self-Assessment Manikin
Time frame: baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Average Change in Mood Based on the Depression PROMIS-CAT
Time frame: baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Change in Delta Band (0.5-4 Hz) Relative Power in the Scale EEG During Recovery
Time frame: baseline, post-ECT from 0-120 minutes
Change in Theta Band (4-8 Hz) Relative Power in the Scalp EEG During Recovery
Time frame: baseline, post-ECT from 0-120 minutes
Change in Alpha Band (8-13 Hz) Power in the Scalp EEG During Recovery
Time frame: baseline, post-ECT from 0-120 minutes
Change in Beta Band (13-20 Hz) Relative Power in the Scalp EEG During Recovery
Time frame: baseline, post-ECT from 0-120 minutes
Change in Anterior-Posterior Functional Connectivity in the Scalp During Recovery
Time frame: baseline, post-ECT from 0-120 minutes
Change in Anterior-Posterior Phase-lag in the Scalp EEG During Recovery
Time frame: baseline, post-ECT from 0 -120 minutes
Change in EEG Entropy in the Scalp EEG During Recovery
Time frame: baseline, Post-ECT from 0 -120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33652270Hickman LB, Kafashan M, Labonte AK, Chan CW, Huels ER, Guay CS, Guan MJ, Ching S, Lenze EJ, Farber NB, Avidan MS, Hogan RE, Palanca BJA. Postictal generalized electroencephalographic suppression following electroconvulsive therapy: Temporal characteristics and impact of anesthetic regimen. Clin Neurophysiol. 2021 Apr;132(4):977-983. doi: 10.1016/j.clinph.2020.12.018. Epub 2021 Jan 28.
- Derived from this study: PubMed 33137572Hickman LB, Hogan RE, Labonte AK, Kafashan M, Chan CW, Huels ER, Ching S, Lenze EJ, Maccotta L, Eisenman LN, Keith Day B, Farber NB, Avidan MS, Palanca BJA. Voltage-based automated detection of postictal generalized electroencephalographic suppression: Algorithm development and validation. Clin Neurophysiol. 2020 Dec;131(12):2817-2825. doi: 10.1016/j.clinph.2020.08.015. Epub 2020 Sep 11.
- Derived from this study: PubMed 29867602Palanca BJA, Maybrier HR, Mickle AM, Farber NB, Hogan RE, Trammel ER, Spencer JW, Bohnenkamp DD, Wildes TS, Ching S, Lenze E, Basner M, Kelz MB, Avidan MS. Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol. Front Psychiatry. 2018 May 14;9:171. doi: 10.3389/fpsyt.2018.00171. eCollection 2018.
- 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.
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 Ketamine and Electroconvulsive Therapy in people with Depression and Delirium, run by Washington University School of Medicine 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: finished, as of the sponsor's last update on 28 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cognitive Function During Recovery: Rate of Recovery (time frame: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.). The study lists 2 primary outcomes in all. 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 NCT02761330, 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 28 Jun 2021.