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Neural Correlates of Ketamine's Anti-suicidal Effects in Bipolar Depression

NCT05177146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-06

No results posted yet for this study

Summary

Bipolar disorder is characterized by manic episodes and episodes of extreme depressive feelings, also known as bipolar depression (BD). Although clinical data does not suggest significant differences in the severity of depressive symptoms between bipolar and unipolar depression, patients with BD are found to be more likely to experience suicidal ideation and suicide attempts. Innovative treatments for suicidality in patients with BD are needed to address tolerability and slow effect limitations of current interventions. Using an open label pilot study, this trial aims to examine the effect of Intravenous (IV) ketamine treatment on acute suicidality in patients with BD. Moreover, the study aims to explore the neurophysiological mechanisms of ketamine's action directly from the cortex in patients with BD, in order to understand the biological mechanism underlying ketamine's therapeutic action.

Conditions

Interventions

DRUG

Intravenous Ketamine (IV)

A sterile form of ketamine hydrochloride will be administered over 40-min IV infusion twice per week on non-consecutive days for four weeks. Dosing schedule is determined based on patient's weight, clinical response and tolerability. First treatment session dose will be calculated based on 0.5 mg/kg. Further dose increase will be determined by the study physician. Dose increase will not exceed 0.8 mg/kg. Patients will be closely monitored by available trained personnel with MD being present on site for the full duration of the 2-h supervision period. Specifically, IV induction will be performed under the direct supervision of anesthesiologist or delegate and psychiatrist. Vital signs will be monitored every 30 minutes during the supervision period. Side effects will be managed by the medical team administering the treatment. If required, appropriate rescue medications will be provided depending on the nature of the adverse event.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Yuliya Knyahnytska, MD, PhD · Centre for Addiction and Mental Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2025-01-10
Completion
2025-01-10

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05177146 on ClinicalTrials.gov