A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible 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) subjects 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, Gaithersburg, Maryland
Conditions: Treatment-resistant Depression
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
Completed
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) 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:
65 years and above
Trial Updated:
03/29/2025
Locations: Not set, Baltimore, Maryland
Conditions: Depressive Disorder, Treatment-Resistant
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, Baltimore, Maryland +1 locations
Conditions: Depressive Disorder, Treatment-Resistant
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
Completed
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.
Gender:
ALL
Ages:
Between 9 years and 17 years
Trial Updated:
03/29/2025
Locations: Sheppard Pratt Health System, Baltimore, Maryland +1 locations
Conditions: Depressive Disorder, Major
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Completed
The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/29/2025
Locations: Not set, Baltimore, Maryland
Conditions: Treatment-resistant Depression
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/27/2025
Locations: Sheppard Pratt Health System, Baltimore, Maryland +1 locations
Conditions: Depressive Disorder, Treatment-Resistant
Pragmatic Trial of Psilocybin Therapy in Palliative Care
Recruiting
This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/03/2025
Locations: Sunstone Therapies, Rockville, Maryland
Conditions: Demoralization
A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue
Completed
Background: Many people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people. Researchers hope that ketamine, compared to a drug called midazolam, can reduce fatigue in people with illnesses. Objective: To test whether ketamine reduces fatigue in cancer survivors and people with chronic illness. Eligibility: Adults between the ages of 18 and 70 who have fatigue and a... Read More
Gender:
ALL
Ages:
Between 18 years and 70 years
Trial Updated:
02/14/2025
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland
Conditions: Fatigue
Investigation of Psychedelic Effects in Psychoactive Substances
Recruiting
The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on... Read More
Gender:
ALL
Ages:
Between 25 years and 55 years
Trial Updated:
02/05/2025
Locations: Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland
Conditions: Psychedelic Effects in Healthy Volunteers
Ketamine for Multiple Sclerosis Fatigue
Recruiting
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
01/08/2025
Locations: Johns Hopkins University, Baltimore, Maryland
Conditions: Multiple Sclerosis Fatigue
Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan
Enrolling By Invitation
This study is a randomized open-label single-blind non-inferiority comparative effectiveness study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).
Gender:
ALL
Ages:
Between 18 years and 90 years
Trial Updated:
08/26/2024
Locations: Johns Hopkins University, Baltimore, Maryland
Conditions: Acute Suicidal Depression (ASD)
Ketamine for OUD and Comorbid Depression (OUDCD)
Terminated
Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression - ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of met... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
03/05/2024
Locations: University of Maryland Baltimore, Baltimore, Maryland
Conditions: Depressive Disorder, Opioid Use Disorder