Treatment Resistant DepressionNCT02522377
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
A study testing Ketamine and Midazolam in people with Treatment Resistant Depression and Major Depressive Disorder, run by The Cleveland Clinic at 1 site in United States.
Trial summary
In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days. Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder, Severe Depression
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 1 Mar 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males/females at least 18 years of age but no older than 65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
- A current depressive episode that has lasted a minimum of 4 weeks.
- Have > 3 trials of antidepressants/augmentation strategies.
- Have a support system capable of transporting the patient post-treatment.
Who cannot join
- Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
- Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, 44195
About this study
Official title: Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days.
Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.
Read the detailed description
The study will compare the effects of standard ketamine dosing with an active placebo arm.
Hypothesis 1:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.
Hypothesis 2:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.
Methods and Design:
Patients with treatment resistant depression who are deemed to be eligible for Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo
Electroconvulsive Treatments:
All patients (independent of their depression scores) will receive the same Electroconvulsive Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment administered by using Thymatron Electroconvulsive Treatment machine.
Study blinding:
Neither the patients, nor the treating psychiatrist or the nurse will be aware of the patient's assigned arm. The success of blinding will be tested after each ketamine treatment with a questionnaire given to the subject, raters, and treating physician.
- Keywords
- Ketamine, Electroconvulsive Therapy, Major Depressive Disorder, Treatment Resistant Depression, electroconvulsive treatment, Severe depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar, Calypsol, Ketanest, Tekam
inter venous injections
MidazolamDrug
Also called Dormicum, Hypnovel, Versed
inter venous injections
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusions | Experimental | Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments. Receives: Drug: Ketamine |
| Midazolam | Active comparator | Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
Measured: visit 17
Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
Measured: visit 17
Secondary outcomes (4)
Montreal Cognitive Assessment (MOCA) at Last Infusion
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
Measured: visit 17
Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.
Measured: visit 17
Controlled Oral Word Association Test (COWAT) at Last Infusion
This is a verbal fluency measure. Outcome is the count of words that meet criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Higher scores reflect a better outcome.
Measured: visit 17
Responder Rate on HAMD-17 by Last Infusion
Count of the patients who showed response (>50% decrease).
Measured: visit 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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 Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Murat Altinay, The Cleveland Clinic
- Investigators
- Murat Altinay, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522377
- Sponsor's protocol ID
- Ketamine ECT
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2015
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02522377
- Acronym / sponsor ID
- Ketamine ECT
- Keywords
- Ketamine, Electroconvulsive Therapy, Major Depressive Disorder, Treatment Resistant Depression, electroconvulsive treatment, Severe depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days.
Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.
Detailed description
The study will compare the effects of standard ketamine dosing with an active placebo arm.
Hypothesis 1:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.
Hypothesis 2:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.
Methods and Design:
Patients with treatment resistant depression who are deemed to be eligible for Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo
Electroconvulsive Treatments:
All patients (independent of their depression scores) will receive the same Electroconvulsive Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment administered by using Thymatron Electroconvulsive Treatment machine.
Study blinding:
Neither the patients, nor the treating psychiatrist or the nurse will be aware of the patient's assigned arm. The success of blinding will be tested after each ketamine treatment with a questionnaire given to the subject, raters, and treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusions | Experimental | Drug: KetamineSubjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments. |
| Midazolam | Active comparator | Drug: MidazolamSubjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males/females at least 18 years of age but no older than 65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
- A current depressive episode that has lasted a minimum of 4 weeks.
- Have > 3 trials of antidepressants/augmentation strategies.
- Have a support system capable of transporting the patient post-treatment.
Key exclusion criteria (3 listed)
- Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
- Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
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: Ketalar, Calypsol, Ketanest, Tekaminter venous injections | Drug | Ketamine Infusions |
| MidazolamAlso: Dormicum, Hypnovel, Versedinter venous injections | Drug | Midazolam |
Primary outcome
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
Time frame: visit 17
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
Time frame: visit 17
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
4 secondary outcomes
Montreal Cognitive Assessment (MOCA) at Last Infusion
Time frame: visit 17
Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
Time frame: visit 17
Controlled Oral Word Association Test (COWAT) at Last Infusion
Time frame: visit 17
Responder Rate on HAMD-17 by Last Infusion
Time frame: visit 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Murat Altinay, MD principal investigator
The Cleveland Clinic
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 Midazolam in people with Treatment Resistant Depression and Major Depressive Disorder, run by The Cleveland Clinic 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 5 inclusion and 3 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 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2019). 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?
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion (time frame: visit 17). 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?
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 Aug 2019.