Clinical trials: Ketamine
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
Schizophrenia
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
- Trial name
- NCT02935725
- Testing
- Low dose AUT00206 800mg, High dose AUT00206 2000 mg, Ketamine
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Autifony Therapeutics Limited
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.
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
Healthy Volunteer
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance…
- Trial name
- NCT03770780
- Testing
- SAGE-718
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Depressive Disorder, Treatment-Resistant
Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain).
- Trial name
- NCT03756129
- Testing
- MIJ821, Ketamine
- Where
- 12 sites in United States, Spain
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
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, 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
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.
Anesthesia
The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia
Closed-loop control of anesthesia involves using feedback from a measure of clinical effect to continuously adjust drug infusion rates.
- Trial name
- NCT03009409
- Testing
- Ketamine Injectable Solution
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- NeuroWave Systems Inc.
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- 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
Personality
Personality and Drug Use (PDU)
The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and…
- Trial name
- PDU (NCT05180149)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Quantified Citizen Technologies Inc.
Treatment Resistant Depression
A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and…
- Trial name
- NCT05414422
- Testing
- PCN-101
- Where
- 21 sites in United States, Germany and 1 more
- Volunteers
- 102 people
- Sponsor
- Perception Neuroscience
Healthy
Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
- Trial name
- NCT00662883
- Testing
- PMI-150 (intranasal ketamine HCl); mometasone furoate
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Healthy
A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.
- Trial name
- AZD6765 EEG (NCT01130909)
- Testing
- AZD6765, Ketamine
- Where
- France
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Surgery, Pediatric Surgery
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain.
- Trial name
- NCT05444036
- Testing
- Ketamine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Egymedicalpedia
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