Major Depressive Disorder Clinical Trial
Official title:
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
In this proof of concept study, the investigators plan to administer iv ketamine interleaved
with ECT days.
Patients with treatment resistant depression who are deemed to be eligible for ECT treatment
will randomly be assigned to either ketamine or active placebo.
The study will compare the effects of standard ketamine dosing with an active placebo arm.
Hypothesis 1:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active
ketamine treatment will lead to a meaningful clinical improvement compared to
Electroconvulsive Treatment and placebo treatment arm.
Hypothesis 2:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active
ketamine treatment will attenuate cognitive side effects.
Methods and Design:
Patients with treatment resistant depression who are deemed to be eligible for
Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo
Electroconvulsive Treatments:
All patients (independent of their depression scores) will receive the same Electroconvulsive
Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment
administered by using Thymatron Electroconvulsive Treatment machine.
Study blinding:
Neither the patients, nor the treating psychiatrist or the nurse will be aware of the
patient's assigned arm. The success of blinding will be tested after each ketamine treatment
with a questionnaire given to the subject, raters, and treating physician.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |