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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Montgomery Åsberg Depression Rating Scale Score

Secondary outcome measures

Basic Language Morningness Scale

Dimensional Anhedonia Rating Scale

Epworth Sleepiness Scale

+5 more

Other outcome measures

Effect of treatment on mnemonic discrimination performance in depression

Measures of psychomotor behaviour to predict depressive severity

Migraine Severity Questionnaire

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

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityOTHER

258 Previous Clinical Trials

83,814 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

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05625555 — Phase 3

Bipolar Disorder Research Study Groups: Midazolam, Ketamine

Bipolar Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05625555 — Phase 3

Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625555 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project accept participants younger than 75 years old?

"The requirements for this clinical trial necessitate that applicants are aged 18 to 65. Separately, there exist 412 trials catered towards patients under the age of eighteen and 1491 studies designed for people over the age of sixty-five."

Answered by AI

Has Ketamine been endorsed by the FDA?

"Considering the data already collected, Ketamine's safety has been judged to be a 3. This score is derived from its Phase 3 status, which implies that it has undergone sufficient clinical trials for effectiveness and multiple attestations of secure usage."

Answered by AI

Am I eligible to enroll in this research project?

"The details of this clinical trial require that participants must be aged 18-65, with a diagnosis of major depressive disorder confirmed by the Diagnostic Assessment Research Tool. In addition to being able to read English fluently (with or without optical correction) and native English speakers for appropriate neurocognitive testing, potential enrollees should have failed at least two antidepressant medications from different pharmacological classes in their present episode; augmentation strategies such as cognitive behavioural therapy or interpersonal therapy may also apply. A MADRS score of 25+ is required and no more than 20% improvement between initial assessment and randomization visits will be accepted along with negative urine pregnancy test"

Answered by AI

Is there still room to participate in this investigation?

"Clinicaltrials.gov specifies that this particular research endeavour is no longer recruiting patients, having originally been posted on September 1st 2023 and last edited on November 15th 2022. Nonetheless, there are currently 2088 other clinical trials actively searching for test subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Predictors of Intravenous Ketamine Response in TRD

Abraham Nunes 2024. "Predictors of Intravenous Ketamine Response in TRD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625555.

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