200 Participants NeededMy employer runs this trial

Ketamine + Psychotherapy for Suicidal Thoughts

(ASPIRED Trial)

Recruiting at 3 trial locations
RD
SP
Overseen ByStephanie Perez, MHA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center at San Antonio
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a one-time ketamine injection combined with a brief therapy session can quickly reduce suicidal thoughts in individuals visiting the emergency department for these reasons. Participants will receive either ketamine (an injectable solution) or a placebo, along with various types of therapy or safety planning. The study aims to identify fast and effective methods to assist those in crisis before hospital admission. It suits adults experiencing serious suicidal thoughts who can communicate in English. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketamine is generally safe for short-term use in people with suicidal thoughts. Studies have found that just one dose of ketamine can quickly lessen these thoughts, sometimes within 24 hours. In controlled trials, participants who received ketamine reported fewer suicidal symptoms compared to those who did not.

While ketamine is usually well-tolerated, some individuals might experience side effects like dizziness or confusion. These effects are typically mild and resolve quickly. Overall, evidence suggests ketamine can be a fast and safe option for those needing immediate help with suicidal thoughts.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using ketamine for suicidal thoughts because it works much faster than traditional antidepressants, which can take weeks to become effective. Ketamine, an anesthetic with unique properties, shows promise in reducing suicidal thoughts within hours or days. This rapid action is crucial for individuals in crisis. Furthermore, combining ketamine with Crisis Response Planning or safety plans offers a comprehensive approach that not only addresses immediate symptoms but also helps develop long-term coping strategies. Unlike standard treatments that typically rely on serotonin pathways, ketamine targets the brain's glutamate system, offering a novel way to potentially enhance mental health outcomes.

What evidence suggests that this trial's treatments could be effective for reducing suicidal thoughts?

Research has shown that ketamine can quickly reduce suicidal thoughts. In some studies, patients who received ketamine felt significantly better and experienced fewer suicidal thoughts within hours. This positive effect can last for days or even weeks, making ketamine a viable option for urgent situations. In this trial, participants may receive ketamine combined with Crisis Response Planning (CRP) or a Safety plan control. Ketamine affects a brain chemical called glutamate, which helps control mood. Combining ketamine with therapy might yield even better results, as therapy provides strategies to manage distressing thoughts. Overall, early research suggests ketamine is a promising option for individuals with severe suicidal thoughts.

Who Is on the Research Team?

RD

Robert DeLorenzo, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for people who come to the emergency department with serious thoughts or actions of self-harm. Participants must be able to take part in a therapy session and receive an injection. Some medical or psychiatric conditions may prevent participation, as decided by the study team.

Inclusion Criteria

Able to read and write English
I am 18 to 70 years old and need hospital admission for suicidal thoughts.

Exclusion Criteria

Known hypersensitivity to ketamine as determined by self-report
Legal or illegal use of ketamine in the previous 90 days as determined by self-report
I am unable to understand the study or give informed consent.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive an intramuscular injection of ketamine or placebo and undergo Crisis Response Planning or Safety Plan Control

1 day
1 visit (in-person)

Monitoring

Participants are monitored for one hour post-injection for side effects such as dizziness, nausea, and confusion

1 hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at multiple time points

56 days
6 visits (in-person or by phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Crisis Response Plan
  • Ketamine Injectable Solution

Trial Overview

The study tests whether a single ketamine injection combined with a brief crisis response therapy session works better than placebo plus therapy at quickly reducing suicidal thoughts in emergency patients. Treatments are given before hospital admission.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo plus CRPExperimental Treatment2 Interventions
Group II: Ketamine plus Safety plan controlExperimental Treatment2 Interventions
Group III: Ketamine plus CRPExperimental Treatment2 Interventions
Group IV: Placebo plus Safety plan controlPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

The effect of a single dose of intravenous ketamine on suicidal ...

Ketamine rapidly reduced suicidal thoughts within one day and for up to one week in depressed patients with suicidal ideation. Ketamine's effects on suicidal ...

Ketamine Infusions and Rapid Reduction of Suicidal ...

Those with repeated ketamine infusions showed a similar reduction of suicidal symptoms at the end of the treatment (SMD, −0.72 [95% CI, −1.00 ...

Ketamine Infusions Linked to Reduced Suicidal and ...

Compared with control groups, a single ketamine infusion was associated with significantly lower suicidal symptom severity at 24 hours ( ...

12 & 13: Ketamine Infusion to Reduce Suicide Ideation ...

Ketamine infusion as a single small dose has shown moderate evidence for acute symptom improvement of suicidal ideation within 24 hours of treatment.

IV Ketamine Shows Rapid Benefits for Suicide Risk ...

Repeated ketamine infusions also reduced suicidal symptoms at the end of treatment, with an SMD of –0.72 (95% CI, –1.00 to –0.43). The ...