A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
03/29/2025
Locations: Not set, Durham, North Carolina
Conditions: Treatment-resistant Depression
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
03/29/2025
Locations: Not set, Durham, North Carolina +1 locations
Conditions: Depressive Disorder, Treatment-Resistant
Anesthetics and Analgesics in Children
Recruiting
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
Gender:
ALL
Ages:
Between 0 years and 17 years
Trial Updated:
01/21/2025
Locations: Duke University Medical Center, Durham, North Carolina
Conditions: Anesthesia, Pain
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
Completed
A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 2-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 8, and 11. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels. Finally, a single-cohort gr... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
05/10/2024
Locations: Duke Early Phase Clinical Research, Durham, North Carolina
Conditions: Major Depressive Disorder
Ketamine Infusion for Sickle Cell Pain Crisis
Withdrawn
The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effe... Read More
Gender:
ALL
Ages:
Between 18 years and 70 years
Trial Updated:
12/29/2021
Locations: Duke Hospital, Durham, North Carolina
Conditions: Anemia; Sickle-Cell, With Crisis, Acute Pain
A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
Terminated
To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect changes in cortical plasticity in responders to a single IV infusion of ketamine as compared to non-responders.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
12/05/2016
Locations: Not set, Durham, North Carolina
Conditions: Major Depressive Disorder
Ketamine In Thoracic Surgery (KITS) Trial
Completed
The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketamine or placebo (0.9% saline in equivalent volume). The alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to significantly different levels of interleukin 6 at 4 a... Read More
Gender:
ALL
Ages:
All
Trial Updated:
07/18/2014
Locations: Duke University Medical Center, Durham, North Carolina
Conditions: Lung Cancer