Clinical trials: Ketamine
Cluster Headache
Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Ketamine has been used clinically IV in a very safe manner by a very small number of clinicians, to treat migraines and CH, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes.
- Trial name
- NCT04179266
- Testing
- Ketamine
- Where
- Denmark
- Volunteers
- 23 people
- Sponsor
- CCH Pharmaceuticals
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
Healthy
A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants
The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine (intranasal administration) and supratherapeutic…
- Trial name
- NCT02737605
- Testing
- Intranasal Esketamine, Intravenous Esketamine, Moxifloxacin
- Where
- Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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 Volunteer
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
This study is a phase 1, double-blind, placebo-controlled crossover study of single, oral dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy…
- Trial name
- NCT03771586
- Testing
- SAGE-718
- Where
- 2 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
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
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
- Trial name
- NCT02674295
- Testing
- Esketamine 50 mg, Esketamine 20 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depression
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with…
- Trial name
- NCT04476446
- Testing
- Esketamine
- Where
- 8 sites in Mexico
- Volunteers
- 41 people
- Sponsor
- Janssen-Cilag, S.A.
Schizophrenia
The Effect of Ketamine on Attentiveness
The objective of this study is to develop an exploratory design for future Proof-of-Concept trials which reliably and accurately measure the central nervous system (CNS) effects of potentially new drugs that oppose the effects of…
- Trial name
- NCT01165294
- Testing
- ketamine
- Volunteers
- 24 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Depressive Disorder
The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression
The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.
- Trial name
- NCT01809340
- Testing
- Minocycline, Ketamine
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 29 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
Depression, Major Depressive Disorder
Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
The purpose of the current study is to perform a unified, homogeneous data collection protocol that includes a large cohort of patients undergoing different treatment options for Major Depressive Disorder (MDD) as an avenue for…
- Trial name
- PREDICT (NCT06002100)
- Testing
- fNIRS measurement
- Where
- 10 sites in United States
- Volunteers
- 540 people
- Sponsor
- Kernel
Treatment Resistant Depression (TRD)
Ketamine Biomarker Validation
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.
- Trial name
- NCT07307768
- Testing
- Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg), Ketamine (0.75 mg/kg)
- Where
- United States
- Sponsor
- Soterix Medical
Depression
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression
The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.
- Trial name
- NCT05268497
- Testing
- Esketamine, Cognitive Behavioral Therapy (CBT), Antidepressant
- Where
- 5 sites in United States
- 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
Depressive Disorder, Major, Suicidal
A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
The purpose of the study is to evaluate the efficacy, safety, and tolerability of SLS-002 (intranasal racemic ketamine) in addition to standard of care on symptoms of Major Depressive Disorder (MDD) and suicidality, in…
- Trial name
- NCT04669665
- Testing
- SLS-002, Standard of care, Intranasal device
- Where
- 21 sites in United States
- Volunteers
- 164 people
- Sponsor
- Seelos Therapeutics, Inc.
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
Healthy Volunteer
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.
- Trial name
- NCT05049343
- Testing
- SAGE-904, Ketamine
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Pain
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
A randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an…
- Trial name
- NCT05508594
- Testing
- CT001, Sufentanil, Ketamine
- Where
- Denmark
- Volunteers
- 220 people
- Sponsor
- Cessatech A/S
Treatment Resistant Bipolar Depression
Adjunctive Oral KET-AD Capsules in Treatment Resistant Bipolar Depression
This study is testing a new oral ketamine treatment called KET-AD in adults with treatment-resistant bipolar depression (TRBD). The study will look at how safe and tolerable the treatment is, and whether it may help improve…
- Trial name
- NCT07644767
- Testing
- KET-AD
- Volunteers
- 160 people
- Sponsor
- Neurocentrx Pharma Pty Ltd