Investigations on the efficacy of ketamine in depression in comparison to electroconvulsive therapy

This is a multi-centre, longitudinal, randomized, crossover trial comparing ECT and ketamine infusion. Participants enrolled in this study will be randomized to receive either ECT (3 per week for 3 or 4 weeks at the discretion of treating psychiatrist) or ketamine infusions (3 per week for 3 or 4 weeks based on their response). Should participants respond, they will move into the maintenance phase of the study. Should they not respond, they will move into the crossover phase of the study and receive the other treatment option. During the maintenance phase, participants in the ECT treatment arm will receive ECT at the discretion of the treating psychiatrist, and participants in the ketamine infusion treatment arm will receive infusions less frequently over time.  This study is a joint effort between the Mood Disorders Research Unit and the ECT Department.

Age range: 

18-70 years of age

Gender: 

Males and females 

Individuals are eligible if they:

  • Is a candidate for standard ECT treatment for their mood disorder.

  • Men and women aged between 18 and 70 years, inclusive. 

  • Body mass index (BMI) < 35.

  • Meets criteria for MDD or BP without psychotic symptoms and currently in a MDE.

  • Be able to understand and comply with the requirements of the study.

Individuals are not eligible if they:

  • Depression secondary to stroke, cancer or other severe medical illnesses.

  • Prior or current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence.

  • Unwilling to maintain their current antidepressant regimen.

  • Unwilling or unable to hold benzodiazepines from noon the day prior to infusions.

  • Unwilling to discontinue any narcotic for a minimum of 5 drug half-lives prior to infusions.

  • Known history of intolerance or hypersensitivity to ketamine. 

  • Evidence of clinically relevant disease, e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, history of cerebrovascular accident, viral hepatitis B or C, acquired immunodeficiency syndrome.

  • Uncorrected hypothyroidism or hyperthyroidism.

  • History of seizure disorder, except febrile convulsions.

This is not a complete list of inclusion/exclusion criteria.  All criteria will be assessed prior to participation in the study. 

Location

The Royal's Institute of Mental Health Research, affiliated with the University of Ottawa
1145 Carling Ave, Ottawa, ON

Recruitment via

Principal Investigator

Dr. Pierre Blier, PhD 

Contact:

Ubah Mohamed, Research Coordinator
+1 (613) 722-6521 x 7828
ubah.mohamed@theroyal.ca

*This study is currently recruiting participants