The purpose of this research study is to find out if the medication known as ketamine can help the symptoms of depression. This drug is approved by the Food and Drug Administration (FDA) but the investigators will use it for a non-FDA approved reason (depression).
Topic Bipolar Disorder
Depression
Compound Ketamine
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
06 January 2017
End date
12 March 2022
Chance of happening
100%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
80
Sex
All
Age
18- 65
Therapy
No
Trial Details
The investigators will enroll 100 adults with treatment-resistant unipolar or bipolar major depression (TRD) across 7 clinical sites and provide three IV ketamine infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). The investigators will begin by studying the predictive value of mechanistic target of rapamycin (mTOR) target engagement by ketamine using a white blood cell (WBC) assay for antidepressive response to ketamine (Aim 1); however, samples will be used to develop multiple blood-based biomarkers for ketamine antidepressive effects (Aim 2). The investigators will also examine the effect of combining multiple blood-based biomarkers for predicting antidepressive response to ketamine in adults with TRD (Aim 3). Baseline WBC markers of impaired cellular energy regulation will be associated with measures of clinical response to ketamine (predictive biomarker). Changes in WBC markers of impaired cellular energy regulation will be associated with clinical response to ketamine (change biomarker).NCT Number NCT03156504
Sponsors & Collaborators
Mayo ClinicThis company doesn't have a full profile yet, it is linked to a clinical trial.
National Network of Depression Centers
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Patients' recovery and non-recovery narratives after intravenous ketamine for treatment-resistant depressionThis qualitative study (n=21) uses interviews to characterize participants' experiences of intravenous (IV) ketamine infusions for treatment-resistant depression. 43% of participants had experienced remission. Five of the non-remitters were characterized as having experienced partial recovery based on their subjective experience.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.