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NMDA Receptor Antagonist

IV Ketamine for Suicidality in Bipolar Disorder (DEEPP Trial)

N/A
Recruiting
Led By Yuliya Knyahnytska, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals currently depressed defined as scoring 14 and above on the Hamilton Rating Scale for Depression-24 Items (HRSD-24)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

DEEPP Trial Summary

This trial is examining the effect of IV ketamine treatment on acute suicidality in patients with BD, as well as exploring the neurophysiological mechanisms of ketamine's action directly from the cortex in patients with BD.

Who is the study for?
This trial is for individuals diagnosed with Bipolar Disorder currently in a depressive episode, experiencing suicidal thoughts. Participants must be able to consent and communicate in English, have a depression score of 14+ on HRSD-24, and a suicide ideation score of 9+. Excluded are those with recent substance abuse, heart failure, severe medical illnesses like uncontrolled hypertension or liver issues, psychotic disorders other than bipolar depression, pregnancy/breastfeeding without birth control use.Check my eligibility
What is being tested?
The study tests the effects of Intravenous Ketamine on acute suicidality in patients with Bipolar Depression (BD). It's an open label pilot study that also aims to understand how ketamine affects brain function by studying its neurophysiological mechanisms directly from the cortex.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of IV ketamine can include confusion or disorientation shortly after administration, nausea or vomiting, increased blood pressure and heart rate during infusion. Long-term side effects may vary but could involve memory problems or bladder issues.

DEEPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently experiencing depression, as indicated by my HRSD-24 score.

DEEPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Impact of a series of therapeutic IV Ketamine 40-min infusions on cortical excitation as measured by intracortical facilitation (ICF)
Ketamine
Secondary outcome measures
Change in symptom severity of Suicidal Ideation as measured by by the Scale of Suicide Ideation (SSI)
Change in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Other outcome measures
Change in quality of life measures as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Safety and Tolerability of IV Ketamine as assessed by monitoring of adverse events
Safety and tolerability as assessed by changes in Blood Pressure (BP)
+2 more

DEEPP Trial Design

1Treatment groups
Experimental Treatment
Group I: Intravenous Ketamine (IV)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,414 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,459 Patients Enrolled for Bipolar Disorder
Yuliya Knyahnytska, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots remaining in this clinical investigation?

"Affirmative, according to clinicaltrials.gov the trial is actively seeking individuals as of now. It was initially posted on May 4th 2022 and last revised on July 19th 2022. The study demands 30 participants across a single site."

Answered by AI

What is the aggregate number of individuals involved in this clinical experimentation?

"Positive. Clinicaltrials.gov confirms that this scientific investigation, which was advertised on May 4th 2022, is actively recruiting for 30 individuals from one site."

Answered by AI

What qualifications must one possess to participate in this trial?

"This medical trial is accepting up to 30 participants and preferentially selecting those between the ages of 24 and 65 with a diagnosis of manic disorder."

Answered by AI

Is there an upper limit of age for participation in this experiment?

"This trial has a set of specific eligibility criteria; amongst which is the fact that patients must be aged between 24 and 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neural Correlates of Ketamine's Anti-suicidal Effects in Bipolar Depression
2022. "Neural Correlates of Ketamine's Anti-suicidal Effects in Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05177146.
~10 spots leftby Apr 2025
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