Major Depressive DisorderKAIDNCT02752724
Ketamine Anesthesia for Improvement of Depression in ECT
A study testing Ketamine and Methohexital in people with Major Depressive Disorder, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine and Methohexital
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 30 Apr 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients or inpatients at the Puget Sound VA with diagnosis of major depressive disorder or bipolar 1 or 2 over the age of 18 undergoing index course ECT
Who cannot join
- uncontrolled hypertension (blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit)
- renal failure
- neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months)
- myocardial infarction in the past 6 months
- known allergies or adverse reactions to ketamine
- American Society of Anesthesiology Physical Class greater than 3
- concomitant psychosis
- schizophrenia or current abuse of alcohol or illicit substances and pregnancy (any trimester)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.
This study is ONLY open to patients eligible to receive healthcare services through the Department of Veterans Affairs at the VA Puget Sound, which means service in the active military, naval or air service or separation under any condition other than dishonorable. Qualifications for VA health care benefits can be found at va.gov.
Read the detailed description
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.
For induction of general anesthesia for ECT, patients will receive either 1mg/kg of methohexital (standard arm) or 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks. The primary outcome in this trial is change in symptoms of depression assessed by standard questionnaires: Patient Health Questionnaire 9 (PHQ9) and Hamilton Depression Rating Scale (HAM-D) score changes from baseline and final ECT administration. Secondary outcomes are changes in cognitive status as assessed by the Montreal Cognitive Assessment (MoCA) scale, quality of seizures and after seizure, changes in serum metabolites (including kynurenine, D/L-serine and other glutamate intermediates) after treatment and need for further ECT courses (relapse) within 1 year after initial course.
Approximately 50 veterans with the diagnosis of major depressive disorder older than 18 years of age undergoing ECT will be randomized and blinded to the intervention. Operative ECT clinicians will not be blinded; clinicians evaluating patients will be blinded. Exclusion criteria for this study include uncontrolled hypertension, blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit, renal failure, neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months), myocardial infarction in the past 6 months, known allergies or adverse reactions to ketamine, American Society of Anesthesiology Physical Class greater than 3, concomitant psychosis, schizophrenia or current abuse of alcohol or illicit substances and pregnancy.
The long term objective of this trial is to systematically characterize ketamine's effect on depression outcomes utilizing validated scoring tools, its safety profile throughout an ECT index course, ketamine's effect on seizure quality and changes in novel translational endpoints to better understand mechanisms of action of ketamine and its potential role in treatment of psychiatric disorders.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine, Methohexital
- Keywords
- major depressive disorder, electroconvulsive therapy, metabolomics, treatment resistant depression, anesthesiology, ketamine, prospective randomized clinical trial
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Ketamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
MethohexitalDrug
Also called Brevital
Methohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Interventional Arm | Experimental | 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks Receives: Drug: Ketamine |
| Methohexital Control Arm | Active comparator | 1mg/kg of methohexital (standard arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks Receives: Drug: Methohexital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring
Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated depression scoring tool (Patient Health Questionnaire 9) administered 24 hours prior to starting an ECT index course treatment (baseline) with a PHQ9 score 72 hours after the last/final ECT session for approximately fifty patients. The PHQ9 Scoring ranges from 0 to 27 in order to monitor depression severity over time for newly diagnosed patients or patients in current treatment for depression.
Measured: Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session
Secondary outcomes (3)
Soluble Amino Acid Metabolomic Biomarkers
Measurement of biomarkers before/after ECT index course serum aqueous metabolites from patient venous blood drawn from intravenous line specifically concentration of serine, tryptophan, quinolinic acid, kynurenine in mcg/dL using mass spectrometry. Samples are collected 30 minutes prior to first ECT session and within 30 minutes after final ECT treatment session.
Measured: 30 minutes prior to first ECT session and within 30 minutes after final ECT session
ECT Seizure Duration
This trial will measure intra-operative seizure length/duration (in seconds) using a standard ECT machine which helps the ECT machine operator determine the total length of time a patient is seizing during each ECT seizure session. An index course of ECT treatment typically involves 6 to 12 seizures titrated to a patient's response. The investigators will record the length of seizure for every treatment session for every patient.
Measured: Length of each intraoperative ECT seizure during an index course typically 6-12 individual seizures measure from start of seizure in operating room to end of seizure in operating room.
Change in Montreal Cognitive Assessment (MoCA) Scoring
Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated cognitive scoring tool (Montreal Cognitive Assessment MoCA) administered 24 hours prior to starting an ECT index course treatment (baseline) with a MoCA score 72 hours after the last/final ECT session for approximately fifty patients. The MoCA Scoring ranges from 0 to 30 in order to rapidly screen for mild cognitive dysfunction.
Measured: Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completion30 Apr 2018
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Charles William Carspecken, MD, MBA, MSc, VA Puget Sound Health Care System
- Investigators
- Anna Borisovskaya, MD, Study director, Puget Sound VA Medical Center, Dept of PsychiatryIrene Rozet, MD, Principal investigator, Puget Sound VA Medical Center, Dept of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752724
- Sponsor's protocol ID
- 00850
- Acronym
- KAID
- Status last verified
- Jun 2018
- First submitted
- 25 Mar 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT02752724
- Acronym / sponsor ID
- KAID / 00850
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, electroconvulsive therapy, metabolomics, treatment resistant depression, anesthesiology, ketamine, prospective randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Apr 2016 (estimated)
- 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.
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.
This study is ONLY open to patients eligible to receive healthcare services through the Department of Veterans Affairs at the VA Puget Sound, which means service in the active military, naval or air service or separation under any condition other than dishonorable. Qualifications for VA health care benefits can be found at va.gov.
Detailed description
The purpose of this prospective randomized clinical trial is to determine if patients receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT) rather than standard of care will have improvement in symptoms of depression after a course of ECT treatments. The investigators hypothesize that utilization of ketamine for induction of general anesthesia during ECT treatments will improve symptoms of depression better than standard care.
For induction of general anesthesia for ECT, patients will receive either 1mg/kg of methohexital (standard arm) or 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks. The primary outcome in this trial is change in symptoms of depression assessed by standard questionnaires: Patient Health Questionnaire 9 (PHQ9) and Hamilton Depression Rating Scale (HAM-D) score changes from baseline and final ECT administration. Secondary outcomes are changes in cognitive status as assessed by the Montreal Cognitive Assessment (MoCA) scale, quality of seizures and after seizure, changes in serum metabolites (including kynurenine, D/L-serine and other glutamate intermediates) after treatment and need for further ECT courses (relapse) within 1 year after initial course.
Approximately 50 veterans with the diagnosis of major depressive disorder older than 18 years of age undergoing ECT will be randomized and blinded to the intervention. Operative ECT clinicians will not be blinded; clinicians evaluating patients will be blinded. Exclusion criteria for this study include uncontrolled hypertension, blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit, renal failure, neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months), myocardial infarction in the past 6 months, known allergies or adverse reactions to ketamine, American Society of Anesthesiology Physical Class greater than 3, concomitant psychosis, schizophrenia or current abuse of alcohol or illicit substances and pregnancy.
The long term objective of this trial is to systematically characterize ketamine's effect on depression outcomes utilizing validated scoring tools, its safety profile throughout an ECT index course, ketamine's effect on seizure quality and changes in novel translational endpoints to better understand mechanisms of action of ketamine and its potential role in treatment of psychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Interventional Arm | Experimental | Drug: Ketamine1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks |
| Methohexital Control Arm | Active comparator | Drug: Methohexital1mg/kg of methohexital (standard arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients or inpatients at the Puget Sound VA with diagnosis of major depressive disorder or bipolar 1 or 2 over the age of 18 undergoing index course ECT
Key exclusion criteria (8 listed)
- uncontrolled hypertension (blood pressure > 180/90 mmHg at the pre-anesthesia clinic visit)
- renal failure
- neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries in the past 6 months)
- myocardial infarction in the past 6 months
- known allergies or adverse reactions to ketamine
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 |
|---|---|---|
| KetamineAlso: KetalarKetamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites. | Drug | Ketamine Interventional Arm |
| MethohexitalAlso: BrevitalMethohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites. | Drug | Methohexital Control Arm |
Primary outcome
Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring
Time frame: Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session
Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated depression scoring tool (Patient Health Questionnaire 9) administered 24 hours prior to starting an ECT index course treatment (baseline) with a PHQ9 score 72 hours after the last/final ECT session for approximately fifty patients. The PHQ9 Scoring ranges from 0 to 27 in order to monitor depression severity over time for newly diagnosed patients or patients in current treatment for depression.
3 secondary outcomes
Soluble Amino Acid Metabolomic Biomarkers
Time frame: 30 minutes prior to first ECT session and within 30 minutes after final ECT session
ECT Seizure Duration
Time frame: Length of each intraoperative ECT seizure during an index course typically 6-12 individual seizures measure from start of seizure in operating room to end of seizure in operating room.
Change in Montreal Cognitive Assessment (MoCA) Scoring
Time frame: Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session
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 6 Jun 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.
Anna Borisovskaya, MD study director
Puget Sound VA Medical Center, Dept of Psychiatry
Irene Rozet, MD principal investigator
Puget Sound VA Medical Center, Dept of Anesthesiology
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 Methohexital in people with Major Depressive Disorder, run by VA Puget Sound Health Care System 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 1 inclusion and 8 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 6 Jun 2018. 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.
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 Depression Patient Health Questionnaire 9 (PHQ9) Scoring (time frame: Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session). 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 6 Jun 2018.