Bipolar Disorder Clinical Trial
Official title:
Synaptic Imaging and Brain Network Activity Following Ketamine in Treatment Resistant Depression
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.
A double-blind active-placebo crossover design will be used to study a single group of people with TRD to assess the effects of ketamine on brain networks activity versus an active placebo (midazolam). Participants will receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of an active placebo (midazolam (0.045mg/kg)), or 3 IV infusions of midazolam followed by 3 IV infusions of ketamine. Treatment order will be randomized in a crossover design. The study will consist of 11 visits including a screening visit, baseline assessments, and two main infusion periods each involving 3 separate IV infusions and a post infusion assessment visit 24 hrs after the third infusion. Ketamine or midazolam will be administered at each of the infusion periods in a crossover design. Assessment visits will include MRI, EEG and cognitive and clinical assessments. Up to 50 subjects will be enrolled to ensure that evaluable data is obtained from 45 subjects. The primary comparison will be within-subject between active treatment and placebo. ;
| 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 | |
| Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
| Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
| Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
| Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 |