Ketamine + Cognitive Training for Suicidal Behavior

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rebecca Price

Must not be taking: St John's Wort

Disqualifiers: Psychosis, Pregnancy, Substance withdrawal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking St John's Wort.

What evidence supports the effectiveness of the drug ketamine combined with cognitive training for reducing suicidal behavior?

Research shows that ketamine can quickly reduce suicidal thoughts in people with depression, with effects lasting up to a week. It may also improve cognitive function, which could help in managing mood disorders and reducing suicidal behavior. ^{1 2 3 4 5}

Is ketamine safe for treating suicidal behavior?

Research suggests that ketamine, when given in controlled doses, is generally safe for short-term use in reducing suicidal thoughts. However, more studies are needed to fully understand its long-term safety and effects. ^{1 3 4 6 7}

How does the drug ketamine differ from other treatments for suicidal behavior?

Intravenous ketamine is unique because it can rapidly reduce suicidal thoughts in patients with depression, working within hours rather than weeks like traditional antidepressants. This fast-acting effect makes it particularly useful for individuals at immediate risk of suicide. ^{1 5 6 7 8}

Research Team

Rebecca B Price, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

My doctor agrees I am a good candidate for ketamine treatment in the hospital.

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

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

Exclusion Criteria

Current pregnancy or breastfeeding

You have had a bad reaction or are allergic to ketamine or esketamine in the past.

I am currently taking St John's Wort.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of intravenous ketamine and undergo cognitive training

1 week

1 visit (in-person)

Post-Treatment Assessment

Participants are assessed for pain intensity, neuropathic pain quality, and satisfaction with treatment

5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including suicidal behaviors and ideation

12 months

Treatment Details

Interventions

• Cognitive training
• Intravenous ketamine

Trial Overview 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.

Participant Groups

Group I: Ketamine + Cognitive Training Experimental Treatment 2 Interventions

Group II: No-infusion (TAU) + Cognitive Training Active Control 1 Intervention

Group III: Ketamine + Sham Training Placebo Group 2 Interventions

Group IV: No-infusion (TAU) + Sham Training Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rebecca Price

Lead Sponsor

Trials

8

Recruited

820+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a randomized controlled trial involving 57 patients with treatment-resistant depression, intravenous ketamine significantly reduced explicit suicidal thoughts within 24 hours compared to a placebo (midazolam), with 53% of ketamine-treated patients showing no suicidal ideation at that time.

Ketamine also decreased implicit suicidal cognition, as measured by the Implicit Association Test, indicating its potential to rapidly alter both conscious and unconscious suicidal thoughts, particularly in those with higher baseline suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ketamine on explicit and implicit suicidal cognition: a randomized controlled trial in treatment-resistant depression. Price, RB., Iosifescu, DV., Murrough, JW., et al.[2022]

In a study of 156 suicidal patients, ketamine infusions significantly reduced suicidal ideation, with early remission at day 1 and day 3 being strong predictors of sustained remission at week 6.

Clinical factors like bipolar disorder and lower initial suicidal thoughts were linked to early remission, but overall, no specific clinical factors reliably predicted long-term outcomes, highlighting the need for ongoing monitoring and comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictive factors and trajectories of suicidal remission over 6 weeks following intravenous ketamine for suicidal ideation. Jollant, F., Demattei, C., Fabbro, P., et al.[2023]

A single dose of ketamine can significantly reduce suicidal thoughts within an hour of administration, with effects lasting up to a week, making it a promising option for patients with severe or treatment-resistant depression.

The antisuicidal effects of ketamine occur independently of its impact on overall depression severity, indicating a unique mechanism of action that warrants further investigation for crisis intervention in suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine for Depression, 6: Effects on Suicidal Ideation and Possible Use as Crisis Intervention in Patients at Suicide Risk. Andrade, C.[2022]

A systematic review of 12 randomized controlled trials found that subanesthetic ketamine, particularly in intravenous form at a dose of 0.5 mg/kg, significantly reduces suicidal ideation in acutely depressed patients, with effects observed within hours.

The benefits of ketamine for reducing suicidal thoughts can last beyond 24 hours, with one study showing sustained improvement up to six weeks after a single dose, although further research is needed to confirm long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rapid anti-suicidal ideation effect of ketamine: A systematic review. Hochschild, A., Grunebaum, MF., Mann, JJ.[2021]

In a study of 201 adults with treatment-resistant major depressive disorder (MDD) or bipolar disorder (BD), intravenous (IV) ketamine significantly reduced symptoms of anxiety, irritability, and agitation in those with mixed features, indicating its effectiveness in treating these symptoms.

Participants with anxiety, irritability, and agitation (AIA) experienced greater reductions in overall depressive symptoms and suicidal ideation compared to those without AIA, suggesting that IV ketamine could be a rapid treatment option for adults with mood disorders presenting with mixed features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of ketamine on anxiety, irritability, and agitation: Implications for treating mixed features in adults with major depressive or bipolar disorder. McIntyre, RS., Lipsitz, O., Rodrigues, NB., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of ketamine on explicit and implicit suicidal cognition: a randomized controlled trial in treatment-resistant depression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A New Perspective on the Anti-Suicide Effects With Ketamine Treatment: A Procognitive Effect. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical predictive factors and trajectories of suicidal remission over 6 weeks following intravenous ketamine for suicidal ideation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Ketamine for Depression, 6: Effects on Suicidal Ideation and Possible Use as Crisis Intervention in Patients at Suicide Risk. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The rapid anti-suicidal ideation effect of ketamine: A systematic review. [2021]

6. Denmark pubmed.ncbi.nlm.nih.gov

The effectiveness of ketamine on anxiety, irritability, and agitation: Implications for treating mixed features in adults with major depressive or bipolar disorder. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of esketamine in the treatment of major depressive disorder with suicidal ideation: study protocol for a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Antisuicidal and antidepressant effects of ketamine and esketamine in patients with baseline suicidality: A systematic review. [2021]