Understanding the Role of the Kappa Opioid Receptor in Ketamine's Attenuation of Suicidal Thoughts

NCT07139106 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: Pro00089428ECR-0-013-24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. This study will use smartphone tracking to monitor real-time responses to stress and positron emission tomography (PET) brain scans to study how ketamine affects brain pathways related to stress and suicidal thoughts in depressed individuals.

Conditions

Major Depressive Disorder (MDD)

Keywords

ketamine; positron emission tomography (PET); kappa opioid receptor; major depressive disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Scale for Suicidal Ideation (SSI)

  Beck Scale for Suicidal Ideation clinician-rated version. Minimum score = 0, Maximum score = 38. Higher scores mean a worse outcome.

  24 hours post-treatment

Study Arms (1)

Ketamine

EXPERIMENTAL

single racemic ketamine hydrochloride 0.5 mg/kg infusion

Drug: Ketamine hydrochloride infusion

Interventions

Ketamine hydrochloride infusion DRUG

single racemic ketamine hydrochloride 0.5 mg/kg infusion

Ketamine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM5 unipolar major depressive episode
• Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.

You may not qualify if:

• Current or past ketamine abuse or dependence ever (lifetime)
• Any medical contraindication to ketamine, including prior ineffective trial of or medically significant adverse reaction to ketamine.
• Clinically significant EKG abnormality in terms of ketamine administration (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) AV block).
• Lifetime schizophrenia, schizoaffective illness, bipolar disorder, current psychotic depression; mild drug or alcohol use disorder in past 2 months; moderate or severe drug or alcohol use disorder in past 6 months; suicidal ideation with plan and/or intent within 6 months; suicide attempt in the past month.
• A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations).
• Current or recent use of antidepressants within 14 days or benzodiazepines within 1 day. Use of fluoxetine or other long-acting antidepressant within 6 weeks.
• Current or recent use of medications known to affect brain biology of interest such as competing for binding sites of PET tracer within 1 month.
• Uncontrolled moderate or severe hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic\[41\]), history of Raynaud's phenomenon, seizures, an open cut, sore, or bone fracture on or near the hands to be used for the cold pressor test.
• Use of more than incidental NSAIDs (including aspirin), anti-inflammatories, immune suppressants or other pain medications.
• Significant active physical illness, particularly if it may affect the brain biology being studied; including chronic pain syndrome and medically compromising eating disorders or epilepsy.
• Lacks capacity to consent
• Aggressive behavior that is a significant threat to others such as physically assaultive behavior (in the last month).
• Pregnancy, abortion or miscarriage in the previous two months or plans to conceive during the course of study participation.
• Currently lactating
• Previous head injury with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A or B will be excluded from study participation.

Sponsors & Collaborators

• American Foundation for Suicide Prevention: collaborator
• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Elizabeth A Bartlett, PhD

CONTACT

646-774-7608; BartlettMINDResearch@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurobiology in Psychiatry

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)