Clinical trials: Esketamine
Healthy
A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
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 using a device with and without a nasal guide in healthy…
- Trial name
- NCT02060929
- Testing
- Esketamine
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- 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 of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
- Trial name
- NCT04282746
- Testing
- JNJ-54135419
- Where
- Belgium
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
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…
- Trial name
- NCT04599855
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 54 sites in United States
- Volunteers
- 477 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD).
- Trial name
- NCT03965858
- 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 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
Adjunctive Treatment of Major Depressive Disorder (MDD)
A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100…
- Trial name
- SOLEO (NCT06340958)
- Testing
- CLE-100
- Where
- 23 sites in United States
- Volunteers
- 99 people
- Sponsor
- Clexio Biosciences Ltd.
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
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
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant…
- Trial name
- NCT07716098
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 22 sites in United States, Japan and 1 more
- Volunteers
- 348 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
54135419SUI3001: 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 the 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 I (NCT03039192)
- Testing
- Esketamine, Standard of Care
- Where
- 56 sites in United States, Bulgaria and 9 more
- Volunteers
- 226 people
- 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
Hepatic Impairment, Normal Hepatic Function
A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in both participants with varying stages of hepatic impairment and healthy participants.
- Trial name
- NCT02611505
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
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
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…
- Trial name
- NCT03185819
- Testing
- Midazolam, Esketamine
- Where
- 51 sites in United States, Belgium and 7 more
- Volunteers
- 147 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression
The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.
- Trial name
- NCT01640080
- Testing
- Esketamine
- Where
- 9 sites in Belgium, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder
The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal…
- Trial name
- DriveSaFe2 (NCT02919579)
- Testing
- Esketamine, Alcohol
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.
- Trial name
- NCT04300621
- Testing
- OTF 1, OTF 2, OTF 3
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Treatment Resistant Major Depressive Disorder
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
- Trial name
- ZYL-730-02 (NCT05438758)
- Testing
- Almond Therapy, Intranasal ketamine (Esketamine), Treatment as Usual
- Sponsor
- Zylorion Health
Healthy
A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants
The purpose of this study is to evaluate the effects of ticlopidine on the pharmacokinetics (PK) of intranasally administered esketamine.
- Trial name
- NCT03298906
- Testing
- Esketamine, Ticlopidine
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC