Clinical trials: Esketamine
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
Depression and Suicide
Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI).
- Trial name
- ENDURE (NCT04760652)
- Testing
- Cognitive Behavioral Therapy CBT, TAU
- Where
- 3 sites in United States
- Volunteers
- 93 people
- Sponsor
- Yale University
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
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
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
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.
Critically Ill Patients
Esketamine Induction Intubation in ICU Patients.
Intubation in the intensive care unit (ICU) is usually an emergency. Pathophysiological changes such as shock, respiratory failure, and metabolic acidosis in critically ill patients can significantly increase the incidence of…
- Trial name
- NCT05464979
- Testing
- Esketamine Hydrochloride 28 Mg in 0.2 mL NASAL SOLUTION [Spravato], midazolam, fentanyl
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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
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.
Depression
Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing…
- Trial name
- VR-KET (NCT06139016)
- Testing
- Virtual reality
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Yale University
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
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
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
Treatment-resistant Depression
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
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…
- Trial name
- TRANSFORM-2 (NCT02418585)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 48 sites in United States, Czechia and 3 more
- Volunteers
- 236 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Episode
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment…
- Trial name
- ROSETTE (NCT05910775)
- Testing
- Pre and Post Treatment Presentations
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Yale University
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.