Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002
NCT06816433
Not Yet Recruiting
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
05/09/2025
Locations: Homestead Associates in Research, Inc., Miami, Florida
Conditions: Post Traumatic Stress Disorder
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A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients
NCT05803551
Not Yet Recruiting
The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).
Gender:
ALL
Ages:
Between 18 years and 99 years
Trial Updated:
05/06/2025
Locations: Mayo Clinic Florida, Jacksonville, Florida
Conditions: Depression
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A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
NCT02606084
Completed
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.
Gender:
ALL
Ages:
Between 18 years and 70 years
Trial Updated:
04/25/2025
Locations: Not set, Miami, Florida
Conditions: Renal Impairment, Healthy
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A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
NCT02782104
Completed
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/25/2025
Locations: Not set, Gainesville, Florida +2 locations
Conditions: Depressive Disorder, Treatment-Resistant
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A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
NCT01998958
Completed
The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
Between 20 years and 64 years
Trial Updated:
04/25/2025
Locations: Not set, Jacksonville, Florida +1 locations
Conditions: Treatment Resistant Depressive Disorder
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54135419SUI3002: A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide
NCT03097133
Completed
The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/25/2025
Locations: University of Miami Health System, Miami, Florida +2 locations
Conditions: Depressive Disorder, Major
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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
NCT02417064
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:
04/25/2025
Locations: Not set, Bradenton, Florida +2 locations
Conditions: Treatment-resistant Depression
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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
NCT02418585
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:
04/25/2025
Locations: Not set, Maitland, Florida
Conditions: Treatment-resistant Depression
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A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
NCT02422186
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:
04/25/2025
Locations: Not set, Miami, Florida
Conditions: Depressive Disorder, Treatment-Resistant
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A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
NCT02493868
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:
04/25/2025
Locations: Not set, Bradenton, Florida +4 locations
Conditions: Depressive Disorder, Treatment-Resistant
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A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
NCT02497287
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:
04/25/2025
Locations: Not set, Miami, Florida
Conditions: Treatment-resistant Depression
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A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
NCT04599855
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:
04/24/2025
Locations: Velocity Clinical Research, Hallandale Beach, Hallandale Beach, Florida +4 locations
Conditions: Depressive Disorder, Treatment-Resistant
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