KetaminePhase 4NCT03666494
Ketamine Co-induction for Patients With Major Depressive Disorder
A Phase 4 study testing Ketamine Hydrochloride, Propofol and Fentanyl in people with Ketamine and Depression, run by University of Saskatchewan.
Trial summary
Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ketamine, Depression, Anesthesia
- What is being tested?
- Ketamine Hydrochloride, Propofol and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder
- Presentation for gynecologic surgery requiring a general anesthetic
Who cannot join
- Marked co-morbid cardiovascular disease
- Marked co-morbid respiratory disease
- History of intracranial hypertension
- History of seizures
- ASA Physical Status Classification IV or greater
- History of psychosis
- Current pregnancy
- Contraindication to ketamine administration
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.
- Conditions
- Ketamine, Depression, Anesthesia
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.
PropofolDrug
As part of the patient's anesthetic induction, they will receive propofol.
FentanylDrug
As part of the patient's anesthetic induction, they will receive fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | As part of the patient's anesthetic induction, they will receive propofol and fentanyl. Receives: Drug: Propofol; Drug: Fentanyl |
| Ketamine Arm | Active comparator | As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride. Receives: Drug: Ketamine Hydrochloride; Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Measured: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
Depression Severity
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Measured: 72 hours post-operative
Depression Severity
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Measured: 7-days post-operative
Depression Severity
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Measured: 30-days post-operative
Secondary outcomes (10)
Pain Score
Verbally reported numeric pain score (out of 10)
Measured: Pre-operatively
Pain Score
Verbally reported numeric pain score (out of 10)
Measured: Upon discharge from PACU, up to 3 hours postoperative
Pain Score
Verbally reported numeric pain score (out of 10)
Measured: 72 hours post-opertaive
Pain Score
Verbally reported numeric pain score (out of 10)
Measured: 7-days post-op
Pain Score
Verbally reported numeric pain score (out of 10)
Measured: 30-days post-op
Analgesia use
Morphine equivalents (in milligrams)
Measured: Pre-operatively
Analgesia use
Morphine equivalents (in milligrams)
Measured: Upon discharge from PACU, up to 3 hours postoperative
Analgesia use
Morphine equivalents (in milligrams)
Measured: 72 hours post-operative
Analgesia use
Morphine equivalents (in milligrams)
Measured: 7-days post-operative
Analgesia use
Morphine equivalents (in milligrams)
Measured: 30-days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for KetamineStudies 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, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Gamble, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666494
- Sponsor's protocol ID
- Bio 18-19
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.
PubMed 12088953McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.
PubMed 25010396Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15.
PubMed 25698228Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20.
PubMed 25038867Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.
PubMed 21557878Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739.
PubMed 24688759Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
PubMed 10686270
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03666494
- Acronym / sponsor ID
- Bio 18-19
- Conditions
- Ketamine, Depression, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Sep 2018 (actual)
- 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.
Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Propofol, Drug: FentanylAs part of the patient's anesthetic induction, they will receive propofol and fentanyl. |
| Ketamine Arm | Active comparator | Drug: Ketamine Hydrochloride, Drug: Propofol, Drug: FentanylAs part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depressive disorder
- Presentation for gynecologic surgery requiring a general anesthetic
Key exclusion criteria (8 listed)
- Marked co-morbid cardiovascular disease
- Marked co-morbid respiratory disease
- History of intracranial hypertension
- History of seizures
- ASA Physical Status Classification IV or greater
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 |
|---|---|---|
| Ketamine HydrochlorideAs part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg. | Drug | Ketamine Arm |
| PropofolAs part of the patient's anesthetic induction, they will receive propofol. | Drug | Control Arm, Ketamine Arm |
| FentanylAs part of the patient's anesthetic induction, they will receive fentanyl. | Drug | Control Arm, Ketamine Arm |
Primary outcome
Depression Severity
Time frame: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Depression Severity
Time frame: 72 hours post-operative
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Depression Severity
Time frame: 7-days post-operative
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
Depression Severity
Time frame: 30-days post-operative
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and >34 is severe depression.
10 secondary outcomes
Pain Score
Time frame: Pre-operatively
Pain Score
Time frame: Upon discharge from PACU, up to 3 hours postoperative
Pain Score
Time frame: 72 hours post-opertaive
Pain Score
Time frame: 7-days post-op
Pain Score
Time frame: 30-days post-op
Analgesia use
Time frame: Pre-operatively
Analgesia use
Time frame: Upon discharge from PACU, up to 3 hours postoperative
Analgesia use
Time frame: 72 hours post-operative
Analgesia use
Time frame: 7-days post-operative
Analgesia use
Time frame: 30-days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 12088953Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.
- Background: PubMed 25010396McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.
- Background: PubMed 25698228Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15.
- Background: PubMed 25038867Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20.
- Background: PubMed 21557878Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.
- Background: PubMed 24688759Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739.
- Background: PubMed 10686270Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
- 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.
Jonathan Gamble, MD principal investigator
University of Saskatchewan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride, Propofol and Fentanyl in people with Ketamine and Depression, run by University of Saskatchewan.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Gamble, MD (306-655-1183, j_gamble@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: At time of discharge from post-anesthetic care unit, until 3 hours post operatvie). The study lists 4 primary outcomes in all. 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 NCT03666494, which also lists 7 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 13 Sep 2018.