Clinical trials: Esketamine
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
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
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
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
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
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.
Depressive Disorder, Treatment-Resistant
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).
- Trial name
- SUSTAIN-3 (NCT02782104)
- Testing
- Esketamine Nasal Spray
- Where
- 173 sites in United States, Argentina and 24 more
- Volunteers
- 1,148 people
- Sponsor
- Janssen Research & Development, LLC
Allergic Rhinitis
Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine
The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms affecting the nose) and co-administration of mometasone or oxymetazoline on the pharmacokinetics (explores what the body does to the…
- Trial name
- NCT02154334
- Testing
- Esketamine, Mometasone, Oxymetazoline
- Where
- Germany
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Treatment Resistant Major Depressive Disorder
Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression
To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.
- Trial name
- ZYL-730-01 (NCT05323019)
- Testing
- Psychotherapy, Treatment as Usual, Intranasal Ketamine (esketamine)
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Zylorion Health
Depressive Disorder, Major
A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI)…
- Trial name
- ESCAPE-LTE (NCT04829318)
- Testing
- Esketamine, SSRI/SNRI
- Where
- 59 sites in Argentina, Belgium and 12 more
- Volunteers
- 183 people
- Sponsor
- Janssen-Cilag Ltd.
Depressive Disorder, Major
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder…
- Trial name
- AVENUE (NCT07227454)
- Testing
- Esketamine, Midazolam
- Where
- 44 sites in United States, Brazil and 5 more
- Volunteers
- 258 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants
The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort…
- Trial name
- NCT02129088
- Testing
- Esketamine
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants
The primary purpose of this study is to evaluate the induction potential of repeated administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in healthy participants using orally administered…
- Trial name
- NCT02568176
- Testing
- Midazolam, Esketamine, Bupropion
- Where
- Belgium
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Drug Abuse
Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users
The primary objective of this study is to evaluate the abuse potential of intranasal esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in nondependent, recreational polydrug users of…
- Trial name
- NCT02682225
- Testing
- Intravenous racemic ketamine, Esketamine 112 mg, Esketamine 84 mg
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian…
- Trial name
- NCT01980303
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.
- Trial name
- NCT01780259
- Testing
- Esketamine, Triazolam
- Where
- Belgium
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC