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Trial record 47 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia (RCC2)

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ClinicalTrials.gov Identifier: NCT02761330
Recruitment Status : Active, not recruiting
First Posted : May 4, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
James S McDonnell Foundation
Information provided by (Responsible Party):
Ben Palanca, Washington University School of Medicine

Brief Summary:
This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.

Condition or disease Intervention/treatment Phase
Depression Delirium Seizures Cognitive Disorders Drug: Ketamine Procedure: Electroconvulsive Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia Reconstitution of Consciousness and Cognition (Phase 2)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Etomidate + ECT
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.
Procedure: Electroconvulsive Therapy
Dose of the ECT charge will be determined during titration session prior to randomization.
Other Name: ECT

Experimental: Ketamine + ECT
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.
Drug: Ketamine
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.

Procedure: Electroconvulsive Therapy
Dose of the ECT charge will be determined during titration session prior to randomization.
Other Name: ECT

Sham Comparator: Ketamine alone
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.
Drug: Ketamine
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.




Primary Outcome Measures :
  1. Change in cognitive function during recovery [ Time Frame: 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6. ]
    Cognition Test Battery


Secondary Outcome Measures :
  1. Change in delta band (0.5-4 Hz) power in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  2. Change in theta band (4-8 Hz) power in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  3. Change in alpha band (8-13 Hz) power in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  4. Change in beta band (13-30 Hz) power in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  5. Change in anterior-posterior functional connectivity in the scalp during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  6. Change in anterior-posterior phase-lag in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  7. Change in EEG entropy in the scalp EEG during recovery [ Time Frame: baseline, post-ECT from 0-120 minutes during treatments days 1-6 ]
    EEG from 5 minute epochs of eyes open and eyes closed, during behavioral tasks, and during quiet resting

  8. Delirium Incidence and Severity [ Time Frame: 0, 60, 120 minutes after return of consciousness during treatment days 1-6. ]
    Assessed using 3D Confusion Assessment Method (CAM)

  9. Suicidality [ Time Frame: assessed on treatment days 1-6 ]
    Scale of Suicidal Ideation

  10. ECT Seizure duration [ Time Frame: up to days 1-6 ]
  11. ECT Electrical dose [ Time Frame: up to 1 day ]
    The dose for each patient will have been determined on a dose-charge titration session prior to randomization and session 1.

  12. 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 ]
    To assess patient blinding of treatment performed, the patient will be asked: "Based on how you feel, did you have ECT today?"

  13. 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 ]
    Mood Self-Assessment Manikin (SAM)

  14. 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 ]
    PROMIS-CAT (Patient Reported Outcomes Measurement Information System-Computer Adaptive Testing) for depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment resistant depression requiring outpatient ECT
  • Planned right unilateral ECT stimulation
  • English speaking
  • Able to provide written informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761330


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
James S McDonnell Foundation

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Responsible Party: Ben Palanca, Assistant Professor of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02761330     History of Changes
Other Study ID Numbers: 201512110
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ben Palanca, Washington University School of Medicine:
Depression
Anesthesia
Electroconvulsive therapy
Delirium
Electroencephalography
Seizures
Ketamine
Etomidate
Physiological Effects of Drugs
Pharmacologic Actions
Confusion
Mental Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Neurologic Manifestations
Cognitive Disorders

Additional relevant MeSH terms:
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Depression
Seizures
Delirium
Cognition Disorders
Behavioral Symptoms
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurocognitive Disorders
Mental Disorders
Anesthetics
Ketamine
Etomidate
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives