Clinical trials: sponsored by Janssen Research & Development, LLC
Asymptomatic Amyloid-positive
An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia
The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite…
- Trial name
- EARLY (NCT02569398)
- Testing
- Atabecestat, 5 mg, Atabecestat, 25 mg
- Where
- 128 sites in United States, Australia and 11 more
- Volunteers
- 557 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
Schizophrenia
A Study of Paliperidone Palmitate 6-Month Formulation
The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the…
- Trial name
- NCT04072575
- Testing
- PP6M injection Dose 1, PP6M injection Dose 2
- Where
- 30 sites in Argentina, Hong Kong and 4 more
- Volunteers
- 178 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
Crohn Disease
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
- Trial name
- TRIDENT (NCT02877134)
- Testing
- JNJ-64304500, Ustekinumab
- Where
- 147 sites in United States, Belgium and 12 more
- Volunteers
- 388 people
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of Lazertinib when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+)…
- Trial name
- NCT04075396
- Testing
- Lazertinib
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Janssen Research & Development, LLC
Alzheimer Disease
An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum
The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and…
- Trial name
- NCT02406027
- Testing
- JNJ-54861911, 10 mg, JNJ-54861911, 25 mg, JNJ-54861911, 5 mg
- Where
- 17 sites in Belgium, France and 4 more
- Volunteers
- 90 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an…
- Trial name
- NCT03227224
- Testing
- JNJ-42847922
- Where
- 101 sites in United States, Bulgaria and 6 more
- Volunteers
- 287 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Anxiety
An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a…
- Trial name
- NCT02498392
- Testing
- JNJ-42165279
- Where
- 32 sites in United States, Moldova and 4 more
- Volunteers
- 161 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder With Anxious Distress
A Study of JNJ-61393215 in the Treatment of Depression
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale…
- Trial name
- NCT04080752
- Testing
- JNJ-61393215
- Where
- 35 sites in United States, Moldova and 3 more
- Volunteers
- 222 people
- Sponsor
- Janssen Research & Development, LLC
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
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
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, Major
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin…
- Trial name
- NCT03559192
- Testing
- JNJ-67953964
- Where
- 53 sites in United States, Germany and 4 more
- Volunteers
- 181 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
Visual Acuity, Geographic Atrophy
A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.
- Conditions
- Visual Acuity, Geographic Atrophy, Macular Degeneration
- Trial name
- PRELUDE (NCT02659098)
- Testing
- CNTO 2476 3.0 x 10^5 cells, Subretinal Delivery System
- Where
- 8 sites in United States
- Volunteers
- 21 people
- Sponsor
- Janssen Research & Development, LLC
Schizophrenia
A Study of Paliperidone Palmitate 6-Month Formulation
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone…
- Trial name
- NCT03345342
- Testing
- PP6M, PP3M 350 mg eq., PP3M 525 mg eq.
- Where
- 138 sites in United States, Argentina and 19 more
- Volunteers
- 841 people
- 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
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 of Ketamine in Patients With Treatment-resistant Depression
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).
- Trial name
- NCT01627782
- Testing
- Ketamine
- Where
- 13 sites in United States
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC