Intramuscular Ketamine for Suicidal Ideation

NCT05105061 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY-20-0149621-1174
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.

Conditions

Suicidal Ideation

Keywords

Suicide; EEG; Ketamine

Outcome Measures

Primary Outcomes (1)

• Change in Auditory Mismatch Negativity (EEG)

  Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.

  Baseline and One hour post injection

Secondary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)

  Baseline and 24 hours post injection

Study Arms (2)

Ketamine (1) then Placebo (2)

EXPERIMENTAL

Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)

Drug: Ketamine (Ketalar); Drug: Placebo

Placebo (1) then Ketamine (2)

PLACEBO COMPARATOR

Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine

Drug: Ketamine (Ketalar); Drug: Placebo

Interventions

Ketamine (Ketalar) DRUG

0.5 mg/kg of body weight

Ketamine (1) then Placebo (2); Placebo (1) then Ketamine (2)

Placebo DRUG

IM injection of matching placebo

Ketamine (1) then Placebo (2); Placebo (1) then Ketamine (2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current clinically significant suicidal ideation, defined as a score of \> or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
• Inpatient status at the time of study initiation.
• to 70 years of age
• Capacity to consent

You may not qualify if:

• Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
• Diagnosis of pervasive developmental disorder
• Diagnosis of a major neurocognitive disorder
• A positive urine pregnancy test
• Currently breastfeeding
• Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
• Medical issues or laboratory abnormalities requiring acute intervention
• Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
• Any lifetime history of ketamine or phencyclidine abuse
• A known hypersensitivity to or history of a serious adverse effect from to ketamine

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Matthew Klein

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: February 1, 2022
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data will be made available the completion of the study.

Locations

US (1)