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NMDA Receptor Antagonist
Ketamine for Treatment-Resistant Depression
Phase 3
Recruiting
Led By Abraham Nunes, MD PhD MBA FRCPC
Research Sponsored by Abraham Nunes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days before the first infusion, 7 days before the first infusion, 1 day before the first infusion, day of the infusions, 24 hours, 7 days, 20 days after each infusion
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to find out which patients with TRD are most likely to benefit from a single low dose of IV ketamine to reduce symptoms quickly.
Who is the study for?
This trial is for adults with treatment-resistant depression (TRD) who have not responded to at least two different antidepressant medications and one augmentation agent. Participants must be fluent in English, able to understand the study, provide consent, and commit to using birth control if applicable. Exclusions include certain medical conditions like liver disease or recent heart attack, substance abuse issues, use of specific drugs like naltrexone, and previous ketamine therapy.
What is being tested?
The trial tests whether a single low dose of IV ketamine can quickly relieve symptoms of TRD compared to an active placebo (Midazolam). It aims to identify predictors for who will benefit most from this treatment by observing responses at 24 hours and sustained effects up to two weeks after administration.
What are the potential side effects?
Ketamine may cause side effects such as disorientation, dizziness, nausea, increased blood pressure and heart rate shortly after infusion. Long-term safety is unclear; hence the study's focus on short-term response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days before the first infusion, 7 days before the first infusion, 1 day before the first infusion, day of the infusions, 24 hours, 7 days, 20 days after each infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days before the first infusion, 7 days before the first infusion, 1 day before the first infusion, day of the infusions, 24 hours, 7 days, 20 days after each infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Montgomery Åsberg Depression Rating Scale Score
Secondary study objectives
Basic Language Morningness Scale
Dimensional Anhedonia Rating Scale
Epworth Sleepiness Scale
+5 moreOther study objectives
Effect of treatment on mnemonic discrimination performance in depression
Measures of psychomotor behaviour to predict depressive severity
Migraine Severity Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
Participants will be randomly assigned to receive Ketamine or Midazolam
Group II: MidazolamActive Control1 Intervention
Participants will receive either Ketamine or Midazolam based on what they initially received
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
Nova Scotia Health AuthorityOTHER
288 Previous Clinical Trials
94,522 Total Patients Enrolled
6 Trials studying Bipolar Disorder
30,531 Patients Enrolled for Bipolar Disorder
Abraham NunesLead Sponsor
Abraham Nunes, MD PhD MBA FRCPCPrincipal InvestigatorNova Scotia Health Authority
Abraham Nunes MD PhD MBA FRCPCPrincipal InvestigatorNova Scotia Health Authority
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications that interact with ketamine or midazolam.I understand and can follow the study's requirements.I have undergone electroconvulsive therapy.I am currently using naltrexone or narcotics.I have been diagnosed with MDD or bipolar disorder without psychosis.I am not pregnant and will use birth control during the study.I've tried at least two different types of antidepressants and one additional medication without success.I have recently started or will start psychotherapy during the trial.My depression is due to another health condition like stroke or cancer.I do not have epilepsy, severe kidney, liver, heart issues, COPD, sleep apnea, stroke history, hepatitis B or C, AIDS, bladder problems, glaucoma, uncontrolled high blood pressure, severe heart failure, thyroid issues not fixed for 30 days, or any unstable health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
- Group 2: Midazolam
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.