Clinical trials: Ketamine
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
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…
- Trial name
- TRANSFORM-3 (NCT02422186)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant)
- Where
- 69 sites in United States, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake…
- Trial name
- ESCAPE-TRD (NCT04338321)
- Testing
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg
- Where
- 171 sites in Argentina, Austria and 22 more
- Volunteers
- 676 people
- Sponsor
- Janssen-Cilag International NV
Healthy
A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of esketamine administered by the intranasal (administered through the nose) and oral routes and to evaluate the effects of clarithromycin on…
- Trial name
- NCT02343289
- Testing
- Esketamine, Clarithromycin
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD).
- Trial name
- NCT07053345
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 6 sites in South Korea
- Volunteers
- 47 people
- Sponsor
- Janssen Korea, Ltd., Korea
Healthy
Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal…
- Trial name
- NCT01244880
- Testing
- Saline, PF-02545920, Ketamine
- Where
- 3 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study of LY2979165 and LY2140023 in Healthy Volunteers
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants. Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165…
- Trial name
- NCT01524237
- Testing
- LY2979165, LY2140023, Ketamine
- Where
- 2 sites in United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Depressive Disorder, Treatment-Resistant
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
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…
- Trial name
- SUSTAIN-1 (NCT02493868)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 155 sites in United States, Belgium and 13 more
- Volunteers
- 719 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
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…
- Trial name
- NCT01957410
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
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
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…
- Trial name
- Aspire II (NCT03097133)
- Testing
- Esketamine, Standard of Care
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 230 people
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteer
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.
- Trial name
- NCT03844906
- Testing
- SAGE-718
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Treatment-resistant Depression
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
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…
- Trial name
- TRANSFORM-1 (NCT02417064)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 90 sites in United States, Belgium and 7 more
- Volunteers
- 346 people
- Sponsor
- Janssen Research & Development, LLC
Healthy, Memory Impairment
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic…
- Trial name
- NCT00985933
- Testing
- AZD8529
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the…
- Trial name
- NCT02846519
- Testing
- Esketamine, Rifampin
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bipolar Depression, Suicidal Ideation
NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of…
- Trial name
- SevereBD (NCT03396601)
- Testing
- Ketamine Hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- NeuroRx, Inc.
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
- Trial name
- NORLIGHT (NCT07284667)
- Testing
- ACP-211
- Where
- 28 sites in United States
- Volunteers
- 153 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Healthy
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
This is a Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to assess the changes in ERP Biomarkers in Healthy Volunteers before and after administration of a sub-anesthetic dose of ketamine.
- Trial name
- NCT04928703
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ERP Biomarker Qualification Consortium
Treatment-resistant Depression
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine.
- Trial name
- NCT05095792
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Entheon Biomedical Corp.
Adjunctive Treatment of Major Depressive Disorder
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy.
- Trial name
- NCT04103892
- Testing
- CLE-100
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 146 people
- Sponsor
- Clexio Biosciences Ltd.
Diabetic Peripheral Neuropathy, Neuralgia
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.
- Trial name
- NCT00476151
- Testing
- EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
- Where
- India
- Volunteers
- 226 people
- Sponsor
- EpiCept Corporation