Clinical trials: Esketamine
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
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal…
- Trial name
- NCT03434041
- Testing
- Esketamine 56 mg, Esketamine 84 mg, Duloxetine (Oral Antidepressant)
- Where
- 30 sites in United States, China
- Volunteers
- 252 people
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study.
- Trial name
- NCT03407872
- Testing
- Esketamine DPI
- Where
- Poland
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Celon Pharma SA
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
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
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
- 39 sites in United States, China and 2 more
- Volunteers
- 348 people
- Sponsor
- Janssen Research & Development, LLC
Renal Impairment, Healthy
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
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.
- Trial name
- NCT02606084
- Testing
- Esketamine
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate…
- Trial name
- NCT03852160
- Testing
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg
- Sponsor
- Janssen-Cilag International NV
Depression
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD)…
- Trial name
- NCT02918318
- Testing
- Intranasal esketamine (28 mg), Intranasal esketamine (56 mg), Intranasal esketamine (84 mg)
- Where
- 43 sites in Japan
- Volunteers
- 202 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
Treatment-resistant Depression
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
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).
- Trial name
- SUSTAIN-2 (NCT02497287)
- Testing
- Esketamine (Intranasal Spray), Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant)
- Where
- 109 sites in United States, Argentina and 19 more
- Volunteers
- 802 people
- 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
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
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
Treatment Resistant Depressive Disorder
A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
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…
- Trial name
- SYNAPSE (NCT01998958)
- Testing
- Esketamine 14 mg, Esketamine 28 mg, Esketamine 56 mg
- Where
- 25 sites in United States, Belgium and 1 more
- Volunteers
- 108 people
- 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
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
Laparoscopy, Anesthesia, Intravenous
The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery
The objective is to evaluate the efficacy and safety of BT-KTM-I(Esketamine Hydrochloride Injection produced by Chengdu Brilliant Pharmaceutical Co., Ltd.) for general anesthesia, using the Originator drug Ketanest®S(Esketamine…
- Trial name
- NCT06092684
- Testing
- BT-KTM-I, Ketanest®S
- Where
- 12 sites in China
- Volunteers
- 358 people
- Sponsor
- Chengdu Brilliant Pharmaceutical Co., Ltd.
Major Depressive Disorder
A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are 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 along with standard care treatment, in reducing the symptoms of major depressive disorder (MDD) (an…
- Trial name
- NCT02133001
- Testing
- Esketamine
- Where
- 14 sites in United States
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
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