Major Depressive EpisodePhase 4NCT00680433
Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
A Phase 4 study testing Ketamine and Saline in people with Major Depressive Episode, run by Northside Clinic, Australia at 1 site in Australia.
Trial summary
Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Ketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2008to Oct 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Satisfy DSM-IV-TR criteria for Major Depressive Episode
- 18 years or over
- Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
- No known sensitivity to ketamine
- No ECT in the last 3 months
- No drug or alcohol abuse in the last 12 months
- Able to give informed consent
- Score at least 24 on Mini Mental State Examination
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties.
In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.
Read the detailed description
This study will report on two related trials. In the outpatient trial, patients will be administered adjunctive ketamine at two different doses (0.25mg/kg; 0.5mg/kg), and a placebo (saline), across 3 consecutive sessions within their regular maintenance ECT course. The order of conditions will be randomised across participants. Patients will be required to learn some words and faces 20 minutes prior to ECT, and complete a detailed cognitive battery 4 hours after ECT on each of the 3 occasions. The purpose of this trial is to determine whether ketamine is superior to placebo in reducing cognitive impairment following ECT and what the optimal dose of ketamine is for minimising cognitive and other side effects. Projected sample for this trial is N = 17.
In the inpatient trial, patients will be randomly assigned to receive ketamine or placebo for the duration of the acute ECT course. Patients will be administered a detailed cognitive battery the day before commencing ECT treatment, the day after the 6th treatment, and 1-3 days and 1 month following the end of the acute ECT course. The purpose of this trial is to examine whether patients in the ketamine condition had superior cognitive outcomes to those in the placebo condition during and following a course of ECT. In addition, depressive symptomatology will be examined throughout the ECT course to determine whether ketamine anaesthesia during ECT has antidepressant, as well as, cognitive benefits. Projected sample for this trial is N = 34.
This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.
- Conditions
- Major Depressive Episode
- Being tested
- Ketamine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.
SalineDrug
Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Ketamine Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Saline (placebo) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory tests
Measured: Before ECT, after 6 ECT treatments, at the end of the ECT course
Secondary outcomes (1)
Depression rating scale
Measured: Before ECT, after each week of treatment, at the end of the ECT course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Major Depressive EpisodeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Clinic, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Wesley Mission
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen K Loo, MB BS FRANZCP, MD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680433
- Sponsor's protocol ID
- HREC 07281
- Status last verified
- Mar 2013
- First submitted
- 16 May 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.
PubMed 16801824Ostroff R, Gonzales M, Sanacora G. Antidepressant effect of ketamine during ECT. Am J Psychiatry. 2005 Jul;162(7):1385-6. doi: 10.1176/appi.ajp.162.7.1385. No abstract available.
PubMed 15994728Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23.
PubMed 9034696White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.
PubMed 6892475Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.
PubMed 12556568Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.
PubMed 18379337MacPherson RD, Loo CK. Cognitive impairment following electroconvulsive therapy--does the choice of anesthetic agent make a difference? J ECT. 2008 Mar;24(1):52-6. doi: 10.1097/YCT.0b013e31815ef25b.
PubMed 18379336Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411Loo CK, Katalinic N, Garfield JB, Sainsbury K, Hadzi-Pavlovic D, Mac-Pherson R. Neuropsychological and mood effects of ketamine in electroconvulsive therapy: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):233-40. doi: 10.1016/j.jad.2012.04.032. Epub 2012 Aug 2.
PubMed 22858219
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
- ClinicalTrials.gov ID
- NCT00680433
- Acronym / sponsor ID
- HREC 07281
- Conditions
- Major Depressive Episode
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Northside Clinic, AustraliaUniversity, hospital or other
- Collaborators
- Wesley Mission
- Study start
- Apr 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 May 2008 (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.
Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties.
In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.
Detailed description
This study will report on two related trials. In the outpatient trial, patients will be administered adjunctive ketamine at two different doses (0.25mg/kg; 0.5mg/kg), and a placebo (saline), across 3 consecutive sessions within their regular maintenance ECT course. The order of conditions will be randomised across participants. Patients will be required to learn some words and faces 20 minutes prior to ECT, and complete a detailed cognitive battery 4 hours after ECT on each of the 3 occasions. The purpose of this trial is to determine whether ketamine is superior to placebo in reducing cognitive impairment following ECT and what the optimal dose of ketamine is for minimising cognitive and other side effects. Projected sample for this trial is N = 17.
In the inpatient trial, patients will be randomly assigned to receive ketamine or placebo for the duration of the acute ECT course. Patients will be administered a detailed cognitive battery the day before commencing ECT treatment, the day after the 6th treatment, and 1-3 days and 1 month following the end of the acute ECT course. The purpose of this trial is to examine whether patients in the ketamine condition had superior cognitive outcomes to those in the placebo condition during and following a course of ECT. In addition, depressive symptomatology will be examined throughout the ECT course to determine whether ketamine anaesthesia during ECT has antidepressant, as well as, cognitive benefits. Projected sample for this trial is N = 34.
This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: KetamineKetamine |
| Placebo | Placebo comparator | Drug: SalineSaline (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Satisfy DSM-IV-TR criteria for Major Depressive Episode
- 18 years or over
- Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
- No known sensitivity to ketamine
- No ECT in the last 3 months
Key exclusion criteria (0 listed)
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 IV will be administered after the administration of the normal anaesthetic agents for ECT. | Drug | Active |
| SalineSaline (placebo) will be administered after the normal anaesthetic agents in ECT. | Drug | Placebo |
Primary outcome
Memory tests
Time frame: Before ECT, after 6 ECT treatments, at the end of the ECT course
1 secondary outcome
Depression rating scale
Time frame: Before ECT, after each week of treatment, at the end of the ECT course
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 29 Mar 2013.
- Background: PubMed 16801824McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.
- Background: PubMed 15994728Ostroff R, Gonzales M, Sanacora G. Antidepressant effect of ketamine during ECT. Am J Psychiatry. 2005 Jul;162(7):1385-6. doi: 10.1176/appi.ajp.162.7.1385. No abstract available.
- Background: PubMed 9034696Rasmussen KG, Jarvis MR, Zorumski CF. Ketamine anesthesia in electroconvulsive therapy. Convuls Ther. 1996 Dec;12(4):217-23.
- Background: PubMed 6892475White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.
- Background: PubMed 12556568Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.
- Background: PubMed 18379337Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.
- Background: PubMed 18379336MacPherson RD, Loo CK. Cognitive impairment following electroconvulsive therapy--does the choice of anesthetic agent make a difference? J ECT. 2008 Mar;24(1):52-6. doi: 10.1097/YCT.0b013e31815ef25b.
- Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
- Derived from this study: PubMed 22858219Loo CK, Katalinic N, Garfield JB, Sainsbury K, Hadzi-Pavlovic D, Mac-Pherson R. Neuropsychological and mood effects of ketamine in electroconvulsive therapy: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):233-40. doi: 10.1016/j.jad.2012.04.032. Epub 2012 Aug 2.
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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.
Colleen K Loo, MB BS FRANZCP, MD principal investigator
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Saline in people with Major Depressive Episode, run by Northside Clinic, Australia at 1 site in Australia.
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 8 inclusion and 0 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 29 Mar 2013. 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Memory tests (time frame: Before ECT, after 6 ECT treatments, at the end of the ECT course). 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 NCT00680433, which also lists 9 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 29 Mar 2013.