Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy

NCT01935115 | Completed Phase 4 DMC

• 1 other identifier: UofSKetamine-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of ketamine, compared to propofol, when used an an anesthetic agent for electroconvulsive therapy (ECT) in the treatment of major depressive disorder (MDD). We hypothesize that ketamine, compared to propofol, will improve the the symptoms of MDD when used as the anesthetic agent to facilitate ECT. Additionally, we hypothesize the dissociative and cardiovascular effects of ketamine will be minimal.

Conditions

Treatment Resistant Depression

Keywords

Depression; MDD; Treatment Resistant Depression; Electroconvulsive Therapy; ECT; Ketamine; Propofol; NMDA

Outcome Measures

Primary Outcomes (1)

• The primary outcome is defined as the number of ECT treatments required to reach a 50% reduction in baseline MADRS (Montgomery-Asberg Depression Scale) score.

  Standard of care for ECT in the Saskatoon Health Region are biweekly sessions for a total of 8 treatments. Occasionally, a patient meets early remission and may not require the full 8 treatments and may be eligible for early withdrawal.

  After 8 treatments or completion of therapy for an expected average of 4 weeks

Secondary Outcomes (9)

• Change in CADSS (Clinician Administered Dissociative States Scale)

  30 minutes after each ECT session and one day after each ECT session for an expected average of 4 weeks

• Change in ALS-18 (Affective Lability Scale)

  30 days after final ECT session for an expected average duration of 2 months

• Change in ECT energy settings and seizure quality

  Within 30 minutes of each treatment for an expected average of 4 weeks

• Hemodynamic instability and respiratory complications

  1 hour after each ECT for an expected average of 4 weeks

• Time to discharge

  1 hour after each treatment for an expected average of 4 weeks

Study Arms (2)

Propofol

ACTIVE COMPARATOR

The control group will receive propofol 1 mg/kg and remifentanil 1 mcg/kg intravenously

Drug: Propofol

Ketamine

EXPERIMENTAL

Study group will receive ketamine 0.75 mg/kg and remifentanil 1 mcg/kg intravenously

Drug: Ketamine

Interventions

Propofol DRUG

Propofol anesthesia for ECT

Also known as: Diprivan

Propofol

Ketamine DRUG

Ketamine anesthesia for ECT

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the diagnostic criteria for major depression according to the Diagnostic and Statistical Manual of Mental Disorders (most recent edition)
• Failure to respond to at least 2 adequate drug therapies for the current depression episode
• MADRS score of 20 or above (moderate - severe
• ASA physical status classification I to III

You may not qualify if:

• Inability to obtain informed consent
• ASA physical status classification IV
• Complication by any serious physical diseases such as cardiovascular disease (including untreated HTN), respiratory disease, cerebrovascular disease, intracranial HTN (including glaucoma), or seizures
• Presence of foreign body (including pacemaker)
• Pregnancy
• Allergies to anesthetics used in study Includes: a) Ketamine b) Propofol c) Eggs d) Egg products e) Soybeans f) Soy products

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatoon Health Region: collaborator
• Royal University Hospital Foundation: collaborator
• Schulman Research Award: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (7)

• Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.

  PMID: 16894061 BACKGROUND

• Berman 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.

  PMID: 10686270 BACKGROUND

• Zarate CA Jr, Brutsche NE, Ibrahim L, Franco-Chaves J, Diazgranados N, Cravchik A, Selter J, Marquardt CA, Liberty V, Luckenbaugh DA. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry. 2012 Jun 1;71(11):939-46. doi: 10.1016/j.biopsych.2011.12.010. Epub 2012 Jan 31.

  PMID: 22297150 BACKGROUND

• Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.

  PMID: 20679587 BACKGROUND

• Okamoto N, Nakai T, Sakamoto K, Nagafusa Y, Higuchi T, Nishikawa T. Rapid antidepressant effect of ketamine anesthesia during electroconvulsive therapy of treatment-resistant depression: comparing ketamine and propofol anesthesia. J ECT. 2010 Sep;26(3):223-7. doi: 10.1097/YCT.0b013e3181c3b0aa.

  PMID: 19935085 BACKGROUND

• Wang X, Chen Y, Zhou X, Liu F, Zhang T, Zhang C. Effects of propofol and ketamine as combined anesthesia for electroconvulsive therapy in patients with depressive disorder. J ECT. 2012 Jun;28(2):128-32. doi: 10.1097/YCT.0b013e31824d1d02.

  PMID: 22622291 BACKGROUND

• Gamble JJ, Bi H, Bowen R, Weisgerber G, Sanjanwala R, Prasad R, Balbuena L. Ketamine-based anesthesia improves electroconvulsive therapy outcomes: a randomized-controlled study. Can J Anaesth. 2018 Jun;65(6):636-646. doi: 10.1007/s12630-018-1088-0. Epub 2018 Feb 21.

  PMID: 29700801 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Interventions

Propofol; Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Jonathan Gamble, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)