Major Depressive Disorder Clinical Trial
Official title:
Open-Label Intravenous Subanesthetic Ketamine for Adolescents With Treatment-Resistant Depression
This study will test the use of ketamine for treatment of depression in adolescents that have not responded to other treatments. We will also examine neurobiological mechanisms of treatment.
Depression frequently emerges during adolescence and is associated with severe outcomes.
Current interventions do not lead to remission for many adolescents. Treatment-resistant
depression (TRD) in adolescence is an ominous prognostic indicator for a lifetime of
suffering and increased risk for suicide. Efforts should be directed toward novel
interventions that could alter this perilous course. Theoretically, restoration of healthy
development during this critical window would substantially improve outcomes over the
lifespan.
Ketamine is a noncompetitive, high-affinity antagonist of the N-methyl-D-aspartate type
glutamate receptor that has long been used for induction and maintenance of anesthesia in
children and adults, and recently has been investigated for its rapid antidepressant effects.
Randomized, double-blind, saline-controlled trials in adults with TRD have demonstrated that
a single, subanesthetic infusion of intravenous (IV) ketamine at 0.5 mg/kg over 40 minutes
can produce a rapid (within 2 hours) antidepressant response (Ibrahim et al., 2011; Zarate et
al., 2006). Recent evidence suggests that serial doses of ketamine may be even more effective
and may lead to more prolonged remission (aan het Rot et al., 2010; Murrough et al., 2012).
Our current research at using serial dosing of IV ketamine among adult veterans with TRD over
a 2-week period has shown promising results, with a response rate of 92% among the 12
participants to date.
No results from any studies examining effectiveness of either single-dose or serial-dose
ketamine have yet been published in adolescents with TRD. Because of the ongoing
neurodevelopment in adolescence, which is thought to confer enhanced neuroplasticity, it is
possible that adolescents with TRD could show greater responses and more sustained remission
than adults with TRD. The biological mechanisms of depression impacted by ketamine are only
now being uncovered in adults (Zarate et al., 2013). Characterization of the neural
mechanisms underlying ketamine response or non-response in adolescents with TRD will
represent a significant advance. The specific aims of this preliminary study are as follows:
Aim #1: To determine the efficacy of repeated-dose subanesthetic IV ketamine among adolescent
patients with TRD.
Hypothesis: Based on previous results in adults with TRD, we predict that response rates will
improve over the course of six treatments of ketamine.
Aim #2: To explore durability of antidepressant response to repeated dose of IV ketamine in a
4-week observational period.
Hypothesis: Based on the inherent neuroplasticity in adolescence due to ongoing
neurodevelopment, adolescents may show a more durable clinical response than has been seen in
adults.
Aim #3: To study the neurobiological mechanisms of response to ketamine. We will examine
relevant biological systems using several different brain imaging indices and measures of
intracellular functioning from peripheral blood.
;
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 |