Psychotherapy + Esketamine for Suicidal Thoughts

(PIK-SI Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Esketamine

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for people with treatment-resistant depression who struggle with ongoing suicidal thoughts. It combines intranasal esketamine, a fast-acting medication for relieving depression symptoms, with a brief form of cognitive behavioral therapy specifically designed to prevent suicide. Researchers aim to determine if this combination reduces suicidal thoughts more effectively than esketamine alone. Individuals who have tried at least one antidepressant without success and continue to experience suicidal thoughts might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could significantly improve mental health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently undergoing an evidence-based psychotherapy treatment, you may not be eligible to participate.

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

Research has shown that intranasal esketamine is generally safe for people. While some studies suggest it might increase the risk of suicide in certain patients, many find it helpful for easing severe depression symptoms. Esketamine has already received FDA approval for treating depression that hasn't responded to other treatments, indicating a certain level of safety.

When combined with Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP), patients have experienced positive results. BCBT-SP has effectively reduced suicide attempts in high-risk groups, demonstrating that it is well-tolerated.

Overall, using esketamine alone or with BCBT-SP has been safe in many cases. However, like any treatment, side effects can occur. Participants should discuss potential risks with their healthcare providers to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for suicidal thoughts, which often involve antidepressants and psychotherapy that can take weeks to work, intranasal esketamine offers a rapid response. Esketamine, a form of ketamine, acts on the brain's glutamate system, which is different from traditional therapies that target serotonin. This unique mechanism allows it to potentially reduce suicidal thoughts within hours. Researchers are excited about combining esketamine with Brief Cognitive Behavioral Therapy for Suicide Prevention, as this approach could provide both immediate relief and long-term coping strategies.

What evidence suggests that this trial's treatments could be effective for suicidal ideation in treatment-resistant depression?

Research has shown that intranasal esketamine, one of the treatments in this trial, can quickly reduce suicidal thoughts in people with depression that hasn't improved with other treatments. In studies, patients experienced a noticeable improvement in their depression symptoms and a decrease in suicidal thoughts shortly after treatment. In this trial, some participants will receive intranasal esketamine alone, while others will receive it combined with a short form of cognitive behavioral therapy designed to prevent suicide (BCBT-SP). Data from a study on military personnel showed that those who received BCBT-SP were 60% less likely to attempt suicide. These findings suggest that combining esketamine with therapy could effectively reduce suicidal thoughts. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with treatment-resistant depression and ongoing suicidal thoughts, despite previous treatments. Participants must pass a safety screening, be able to consent to treatment at UC San Diego Health's Psychiatry program, and commit to the treatment schedule.

Inclusion Criteria

My gender does not limit my participation.

I am between 18 and 70 years old.

I have ongoing suicidal thoughts confirmed by a Beck score of 4 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined intranasal esketamine with brief cognitive behavioral therapy for suicide prevention

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Cognitive Behavioral Therapy for Suicide Prevention
• Intranasal Esketamine

Trial Overview

The study tests if intranasal esketamine combined with brief cognitive behavioral therapy reduces suicidal thoughts more effectively than esketamine alone in patients who haven't improved after other treatments. It also aims to find biological markers of response using brain stimulation and recording techniques.

How Is the Trial Designed?

Group I: BCBT-SP + Intranasal Esketamine Experimental Treatment 2 Interventions

Brief Cognitive Behavioral Therapy for Suicide Prevention combined with Intranasal Esketamine

Group II: Intranasal Esketamine Active Control 1 Intervention

Naturalistic Intranasal Esketamine

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07396220

Psychotherapy Combined With Intranasal Esketamine for ...

The purpose of this study is to examine the effects of combined intranasal esketamine with brief cognitive behavioral therapy for suicide prevention (BCBT-SP) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8479594/

Brief Cognitive-Behavioral Therapy for Suicide Prevention ...

Recent data from a 2-year randomized clinical trial (RCT) among 152 active duty military personnel found that those who received BCBT-SP were 60% less likely to ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178123005358

Cognitive behavioral therapy following esketamine for ...

Cognitive behavioral therapy (CBT) is highly effective in relapse prevention and has been shown to prevent suicide attempts in high-risk populations. •. The ...

4.

mdpi.com

mdpi.com/2077-0383/15/1/250

Effectiveness of Intranasal Esketamine on Suicidal Ideation ...

The mean lifetime number of suicide attempts was 0.4 ± 0.8, and 70% of the patients reported a positive family history of depression or suicidal behavior.

5.

researchgate.net

researchgate.net/publication/399153335_Effectiveness_of_Intranasal_Esketamine_on_Suicidal_Ideation_and_Depressive_Symptoms_in_Patients_with_Treatment-Resistant_Depression_A_Longitudinal_Study

Effectiveness of Intranasal Esketamine on Suicidal Ideation ...

Conclusions: Intranasal Esketamine has been shown to be effective in the rapid reduction and lysis of SI in patients with TRD. Male gender was ...

6.

researchgate.net

researchgate.net/publication/375086531_Cognitive_Behavioral_Therapy_following_Esketamine_for_Major_Depression_and_Suicidal_Ideation_for_Relapse_Prevention_the_CBT-ENDURE_Randomized_Clinical_Trial_Study_Protocol

the CBT-ENDURE Randomized Clinical Trial Study Protocol

Also, research results showed that cognitive behavioral therapy prevents suicide attempts in high-risk populations (Kitay et al., 2023) . A study also indicated ...