Intramuscular Ketamine for Suicidal Ideation

Suicidal Ideation Clinical Trial

Official title:

Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05105061
• Other study ID #: STUDY-20-01496
• Secondary ID: 21-1174
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2022
• Est. completion date: March 24, 2022

Study information

• Verified date: March 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Drug:
• Ketamine (Ketalar)
0.5 mg/kg of body weight
• Placebo
IM injection of matching placebo

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)	Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.	Baseline and 24 hours post injection