Intramuscular Ketamine for Suicidal Ideation

NCT ID: NCT05105061

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-03-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketamine (1) then Placebo (2)

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

Group Type: EXPERIMENTAL

Ketamine (Ketalar)

Intervention Type: DRUG

0.5 mg/kg of body weight

Placebo

Intervention Type: DRUG

IM injection of matching placebo

Placebo (1) then Ketamine (2)

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

Group Type: PLACEBO_COMPARATOR

Ketamine (Ketalar)

Intervention Type: DRUG

0.5 mg/kg of body weight

Placebo

Intervention Type: DRUG

IM injection of matching placebo

Interventions

Ketamine (Ketalar)

0.5 mg/kg of body weight

Intervention Type: DRUG

Placebo

IM injection of matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 18 to 70 years of age
• Capacity to consent

Exclusion Criteria

• 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
• Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Matthew Klein

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Klein

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

21-1174

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY-20-01496

Identifier Type: -

Identifier Source: org_study_id