Electroconvulsive TherapyEarly Phase 1NCT04022226
EEG Characteristics in ECT
A Early Phase 1 study testing Ketamine and Methohexital in people with Electroconvulsive Therapy and Direct Current Electroencephalogram, run by University of New Mexico at 1 site in United States.
Trial summary
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Electroconvulsive Therapy, Direct Current Electroencephalogram, Ketamine
- What is being tested?
- Ketamine and Methohexital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Oct 2020
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
- The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
- Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and
- Age range between 18 and 65 years of age.
Who cannot join
- Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease);
- Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- Current drug or alcohol use disorder, except for nicotine and marijuana
- Adults unable to consent, pregnant women, prisoner
- Non-English speakers
- Patients that cannot tolerate Methohexital and Ketamine.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Mental Health Center
Albuquerque, New Mexico, 87106
About this study
Official title: A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
Read the detailed description
This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.
- Conditions
- Electroconvulsive Therapy, Direct Current Electroencephalogram, Ketamine, Spreadind Depression
- Being tested
- Ketamine, Methohexital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Induction agent that suppresses infra-slow waves
MethohexitalDrug
Induction agent that does not suppress infra-slow waves
| Study group | Role | What they receive |
|---|---|---|
| Methohexital | Active comparator | Standard of care anesthesia that does not affect slow wave characteristics Receives: Drug: Methohexital |
| Ketamine | Experimental | Standard of care anesthesia that suppresses slow wave characteristics Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assessed for Clinical Efficacy of ECT
Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression.
Inadequate sample size due to COVID. Study was closed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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.
- Other trials for Electroconvulsive TherapyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Miller, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022226
- Sponsor's protocol ID
- 19-228
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2019
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT04022226
- Acronym / sponsor ID
- 19-228
- Conditions
- Electroconvulsive Therapy, Direct Current Electroencephalogram, Ketamine, Spreadind Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
Detailed description
This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methohexital | Active comparator | Drug: MethohexitalStandard of care anesthesia that does not affect slow wave characteristics |
| Ketamine | Experimental | Drug: KetamineStandard of care anesthesia that suppresses slow wave characteristics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
- The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
- Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and
- Age range between 18 and 65 years of age.
Key exclusion criteria (6 listed)
- Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease);
- Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- Current drug or alcohol use disorder, except for nicotine and marijuana
- Adults unable to consent, pregnant women, prisoner
- Non-English speakers
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 |
|---|---|---|
| KetamineInduction agent that suppresses infra-slow waves | Drug | Ketamine |
| MethohexitalInduction agent that does not suppress infra-slow waves | Drug | Methohexital |
Primary outcome
Number of Participants Assessed for Clinical Efficacy of ECT
Time frame: 1 year
Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression. Inadequate sample size due to COVID. Study was closed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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 Early Phase 1 study testing Ketamine and Methohexital in people with Electroconvulsive Therapy and Direct Current Electroencephalogram, 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 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 26 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2024). 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?
Number of Participants Assessed for Clinical Efficacy of ECT (time frame: 1 year). 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 26 Oct 2024.