Ketamine Hydrochloride for Manic Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Canadian Rapid Treatment Center of Excellence (CRTCE), Mississauga, Canada
Manic Disorder+6 More
Ketamine Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing RCTs have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder depression (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of repeated sub-anesthetic maintenance doses of IV ketamine in, over a period of twelve weeks. Open-label ketamine infusions will be provided on a flexible schedule (every 2-4 weeks) with flexible dosing (0.5-1.0mg/kg over 40 minutes) titrated to optimize benefits, while minimizing the dosage and frequency over a 12-week extension period. All patients participating in this open-label study will have completed an acute course of infusions in a parent two-site, phase II, double-blinded midazolam-controlled RCT trial. In addition to this acute course of four infusions, a maximum of six infusions will be provided over the 12-week period. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Canadian Rapid Treatment Centre of Excellence), single-arm, open label, 12-week extension trial evaluating the effects of flexibly-dosed adjunctive ketamine infusions for TRBD to maintain antidepressant effects in participants who achieved an antidepressant response (MADRS decrease by >50%) or remission (MADRS < 12) following an acute course of four ketamine infusions is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining by a linear mixed model from baseline to week 12. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects.

Eligible Conditions

  • Bipolar I Disorder
  • Bipolar Disorder, Type II
  • Depression, Bipolar
  • Manic Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Manic Disorder

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 weeks

12 weeks
Change in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS)
Quality of Life (QOL)
Recruitment and Retention Rates
Treatment Emergent Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Manic Disorder

Side Effects for

Ketamine
1%Lightheadedness with low blood pressure
1%PTSD
1%Pump Malfunction
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03156504) in the Ketamine ARM group. Side effects include: Lightheadedness with low blood pressure with 1%, PTSD with 1%, Pump Malfunction with 1%.

Trial Design

1 Treatment Group

Ketamine
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Ketamine Hydrochloride · No Placebo Group · Phase 2

Ketamine
Drug
Experimental Group · 1 Intervention: Ketamine Hydrochloride · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Trial Background

Rodrigo Mansur, Principal Investigator
Principal Investigator
University Health Network, Toronto
Closest Location: Canadian Rapid Treatment Center of Excellence (CRTCE) · Mississauga, Canada
N/AFirst Recorded Clinical Trial
0 TrialsResearching Manic Disorder
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female between the age of 21 and 65, inclusive.
You have been diagnosed with Bipolar I or II Disorder, currently experiencing a Major Depressive Episode without psychotic features

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.