Bipolar Disorder Clinical Trial
Official title:
Repeated Ketamine Infusions for Treatment-Resistant Bipolar Disorder: A Randomized, Double-blind, Midazolam-controlled, Phase II Clinical Trial
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 randomized control trials (RCTs) have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. 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 Ontario Shores Centre for Mental Health Sciences), phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe TRBD (type I & II) is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining the between group difference in change from baseline to day 14, using analysis of covariance (ANCOVA), with 14-day MADRS as the outcome and baseline MADRS and stratification variables (sex, bipolar type) as covariates. 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 (to day 28).
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 | |
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|