THRIVE Intervention for Suicide Crisis

(THRIVE Trial)

Overseen By Anthony R Pisani, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centerstone Research Institute

Disqualifiers: Acute psychosis, Communication issues

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

137 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests THRIVE, a session using a tablet to help suicidal individuals at Crisis Stabilization Centers. It involves talking about their crisis, understanding it better, and setting future goals to increase hope and self-confidence. The goal is to provide more effective care than typical emergency departments. Thrive has been shown to be effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the THRIVE treatment for suicide crisis?

Research shows that ketamine, a drug similar to some components of THRIVE, can rapidly reduce suicidal thoughts in patients, with effects lasting up to six months. This suggests that THRIVE might also be effective in quickly addressing suicidal crises. ^{1 2 3 4 5}

Is the THRIVE Intervention for Suicide Crisis safe for humans?

The safety of treatments like esketamine, which is used for major depression with suicidal thoughts, has been studied and found to have no unexpected safety concerns in clinical trials. Ketamine, a similar treatment, has also been shown to be safe and effective in reducing suicidal symptoms in high-risk patients. ^{1 4 6 7 8}

Research Team

Jennifer Lockman, PhD

Principal Investigator

Centerstone Research Institute

Eligibility Criteria

This trial is for English-speaking residents of Davidson County who are at increased risk for suicide and have been admitted to a Crisis Stabilization Center. Participants must be able to give informed consent, provide contact information for follow-ups, and discuss their suicidal thoughts or attempts. Those acutely psychotic or unable to communicate with the research team cannot join.

Inclusion Criteria

Medically and clinically cleared by onsite psychiatrist/nurse practitioner

Increased risk for suicide (Patient safety screener-3, Item 2 and/or 3 is 'Yes')

English-speaking

Exclusion Criteria

Individuals unable to communicate with the research team

Individuals who are acutely psychotic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive the THRIVE intervention, a 60-minute, narrative, technology-based, recovery-oriented intervention tailored for CSC settings

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with surveys administered at baseline, discharge, 1 month, and 3-month follow-up time points

3 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• THRIVE
• Usual Care

Trial Overview The study tests THRIVE, a new 60-minute recovery-oriented intervention using narrative and technology, against usual care in Crisis Stabilization Centers. It aims to see if THRIVE can better help individuals understand their suicide crisis, reduce suicidal thoughts, and support recovery.

Participant Groups

Group I: Experimental: THRIVE + Usual Care Experimental Treatment 2 Interventions

Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk

Group II: Usual Care Active Control 1 Intervention

Individuals presenting to a community-based crisis stabilization center who are age 18-plus and screen positive for suicide risk

THRIVE is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Lynparza for:

• Ovarian cancer
• Breast cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Centerstone Research Institute

Lead Sponsor

Trials

4

Recruited

1,700+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Findings from Research

In a study involving 16 recent suicide attempters, a single intravenous dose of ketamine (0.5 mg/kg) led to rapid and significant reductions in suicidal thoughts within 24 hours, with effects lasting up to 6 months post-infusion.

The results indicate that ketamine is a safe and effective treatment for reducing suicidality in high-risk patients, suggesting it could be integrated into existing healthcare settings for those in acute psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. Shivanekar, S., Gopalan, P., Pizon, A., et al.[2023]

The STAR*D study successfully implemented NIMH guidelines to manage suicidal risk in a large clinical trial involving an anticipated 4000 participants, focusing on treatment-resistant depression.

Innovative methods, such as an interactive voice response system, were utilized to enhance safety monitoring and ensure timely alerts for clinicians and safety officers regarding suicidal subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. Nierenberg, AA., Trivedi, MH., Ritz, L., et al.[2022]

In a post-hoc analysis of 53 patients with major depressive disorder and suicidal ideation, intranasal esketamine showed a significant improvement in depression scores compared to placebo, with a mean difference of -3.8 on the MADRS scale by Day 2.

The safety profile of intranasal esketamine in the Asian subgroup was consistent with the overall ASPIRE I cohort, indicating no unexpected safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of esketamine nasal spray in addition to standard of care in patients with major depressive disorder who have active suicidal ideation with intent: A subgroup analysis of the Asian cohort of ASPIRE I (a randomized, double-blind, placebo-controlled study). Hong, JP., Malek, AZA., Li, CT., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

An Emergency Department-Initiated Intervention to Lower Relapse Risk after Attempted Suicide. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy following esketamine for major depression and suicidal ideation for relapse prevention: The CBT-ENDURE randomized clinical trial study protocol. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Clinical trials for rapid changes in suicidal ideation: Lessons from ketamine. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of esketamine nasal spray in addition to standard of care in patients with major depressive disorder who have active suicidal ideation with intent: A subgroup analysis of the Asian cohort of ASPIRE I (a randomized, double-blind, placebo-controlled study). [2023]

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

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis. [2023]