What side effects are associated with this type of intervention?

Ketamine, used for its rapid antidepressant effects in treating suicidality, is associated with several side effects. Common adverse effects include dizziness, dissociation, cognitive impairment, and psychotomimetic symptoms such as hallucinations. It can also cause increases in blood pressure and heart rate, nausea, and vomiting. In the context of ECT, ketamine may lead to post-ECT disorientation, restlessness, and prolonged seizure duration. Monitoring for these side effects is crucial during treatment.

What prior FDA approvals exist?

The FDA has approved esketamine, a derivative of ketamine, for the treatment of treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior. Esketamine is administered as a nasal spray and has shown rapid antidepressant effects, similar to those being studied with intravenous ketamine. This approval is significant as it provides a fast-acting option for patients in acute crisis, addressing the urgent need for rapid symptom relief in suicidal patients.

What other types of research exist?

Promising novel alternatives to ketamine for rapid antidepressant effects in patients with suicidal ideation include psilocybin-assisted psychotherapy and MDMA-assisted psychotherapy. Both have shown potential in reducing suicidal ideation and depression. Electroconvulsive therapy (ECT) is also a well-established option for rapid relief of severe depression and suicidality.

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NMDA Receptor Antagonist

Ketamine + Cognitive Training for Suicidal Behavior

Phase 4

Waitlist Available

Led By Rebecca B Price, PhD

Research Sponsored by Rebecca Price

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who receive ketamine will: be between the ages of 18 and 65 years

possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document

Must not have

Patients taking St John's Wort

Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trajectories from 24hrs through 12 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to see how a single IV dose of ketamine affects suicidal patients. After receiving ketamine, patients will use a computer program designed to extend the drug's positive effects. The goal is to find a fast and effective way to reduce suicidal thoughts and help patients learn better coping strategies. Ketamine has been identified as a potential fast-acting anti-suicidal treatment, with evidence supporting its rapid effects on reducing suicidal ideation in patients with depression.

Who is the study for?

This trial is for adults aged 18-65 who are hospitalized, experiencing suicidality, and need psychiatric hospitalization. They must be able to consent and not have a history of severe reactions to ketamine or certain mental conditions like acute psychosis or developmental disorders with significant impairments.

What is being tested?

The study tests if a single dose of intravenous ketamine can reduce suicidal thoughts quickly. It also examines whether combining this treatment with computer-based cognitive training can extend its benefits.

What are the potential side effects?

Ketamine may cause side effects such as disorientation, dizziness, nausea, increased blood pressure, mood swings, blurred vision, and in rare cases dissociation or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I understand the study requirements and have signed the consent form.

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I was referred for a psychiatric evaluation due to feeling suicidal and need to be hospitalized.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking St John's Wort.

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I do not have severe mental health issues like psychosis, mania, or dementia.

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I read below a 5th-grade level and prefer not to have materials read to me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trajectories from 24hrs through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trajectories from 24hrs through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and trajectories from 24hrs through 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)

Secondary study objectives

Adult Suicide Ideation Questionnaire

Montgomery Asberg Depression Rating Scale

Quick Inventory of Depressive Symptoms

+1 more

Other study objectives

Acceptability: infusion

Ease of use: Cognitive Training

Future likelihood of use: Cognitive Training

+8 more

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT03237286

97%

dissociative effects

68%

dizziness

39%

dry mouth

30%

nausea

17%

headache

17%

restlessness

17%

sweating

16%

decreased energy

12%

increased appetite

11%

palpitations

10%

anxiety

emotional indifference

elevated blood pressure

tremors

difficulty sleeping: too much

emesis

elevated heart rate

difficulty focusing vision

loss of sexual desire

feeling "high" (per verbal report)

difficulty sleeping: too little

difficulty urinating

feeling "discombobulated"

increased weight

lowered pulse

suicidal ideation

tinnitus

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Saline

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Ketamine + Cognitive TrainingExperimental Treatment2 Interventions

Group II: No-infusion (TAU) + Cognitive TrainingActive Control1 Intervention

Group III: Ketamine + Sham TrainingPlacebo Group2 Interventions

Group IV: No-infusion (TAU) + Sham TrainingPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive training

2019

Completed Phase 3

~1480

Ketamine

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ketamine works by blocking the NMDA receptor, preventing glutamate activation, which can mitigate opioid tolerance and provide rapid antidepressant effects. Its anti-suicidal effects are both robust and transient, offering immediate relief from severe depressive symptoms and suicidal ideation. This rapid action is crucial for patients who have attempted suicide, as it can quickly stabilize them and provide a critical window for other long-term treatments to be implemented.

Ketamine for the treatment of mental health and substance use disorders: comprehensive systematic review.