Intravenous ketamine for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+1 More
Intravenous ketamine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how well ketamine + cognitive training works for depression, compared to ketamine or cognitive training alone. They will look at 3 primary outcomes related to brain function and 1 primary outcome related to depression severity.

Eligible Conditions
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Depression

Study Objectives

5 Primary · 15 Secondary · Reporting Duration: Trajectories from 24 hours through Month 12 post-infusion

Day 30
Affective flexibility/inhibition
Cognitive Flexibility
Executive-salience network functional connectivity
Implicit self-representations
Montgomery Asberg Depression Scale
Neural activation and connectivity patterns
Month 12
Cognitive Flexibility Scale
Cognitive Triad Inventory
Columbia-Suicide Severity Rating Scale
Ethanol
PROMIS measures-anger
Anxiety
PROMIS measures-cognitive function
Mental Depression
PROMIS measures-positive affect
PROMIS measures-sleep disturbance
PROMIS measures-substance use
WHO Disability Assessment Scale (SR)
Day 5
Neuroplasticity-related markers in blood
Month 12
Quick Inventory of Depressive Symptoms

Trial Safety

Safety Progress

1 of 3

Other trials for Depression

Trial Design

3 Treatment Groups

Ketamine + Cognitive Training
1 of 3
Ketamine + Sham Training
1 of 3
Saline + Cognitive Training
1 of 3
Experimental Treatment
Non-Treatment Group

154 Total Participants · 3 Treatment Groups

Primary Treatment: Intravenous ketamine · Has Placebo Group · Phase 1 & 2

Ketamine + Cognitive TrainingExperimental Group · 2 Interventions: Intravenous ketamine, Computer-based Cognitive Training · Intervention Types: Drug, Behavioral
Ketamine + Sham Training
Drug
ShamComparator Group · 1 Intervention: Intravenous ketamine · Intervention Types: Drug
Saline + Cognitive Training
Behavioral
PlaceboComparator Group · 1 Intervention: Computer-based Cognitive Training · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: trajectories from 24 hours through month 12 post-infusion

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,522 Previous Clinical Trials
1,814,436 Total Patients Enrolled
601 Trials studying Depression
241,428 Patients Enrolled for Depression
Rebecca PriceLead Sponsor
5 Previous Clinical Trials
512 Total Patients Enrolled
1 Trials studying Depression
60 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
People who have not responded to one or more adequate trials of antidepressant drugs within the current depressive episode are determined by the Antidepressant Treatment History Form.
The person has a score of 25 or more on the Montgomery Asberg Depression Rating Scale.
The individual must be able to understand the agreement and consent forms in order to participate in the study.
The patient agrees to identify another individual as a contact person while they are enrolled in the study.
You are between the ages of 18 and 60 years.
indicates that the individual has a cognitive triad that is significantly different from the normative mean and lower self-esteem scores.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%