Clinical trials: Ketamine
Driving Performance
Assessment of Effect of Rapastinel on Driving Performance
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a…
- Trial name
- NCT03814733
- Testing
- Rapastinel, Alprazolam, Ketamine
- Where
- 2 sites in United States, Canada
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
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 Depression
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine.
- Trial name
- NCT05095792
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Entheon Biomedical Corp.
Healthy, Memory Impairment
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic…
- Trial name
- NCT00985933
- Testing
- AZD8529
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
Healthy
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
This is a Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to assess the changes in ERP Biomarkers in Healthy Volunteers before and after administration of a sub-anesthetic dose of ketamine.
- Trial name
- NCT04928703
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ERP Biomarker Qualification Consortium
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
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
Healthy Volunteers
A Study of LY2979165 and LY2140023 in Healthy Volunteers
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants. Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165…
- Trial name
- NCT01524237
- Testing
- LY2979165, LY2140023, Ketamine
- Where
- 2 sites in United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Major Depressive Disorder
A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression
The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.
- Trial name
- NCT01640080
- Testing
- Esketamine
- Where
- 9 sites in Belgium, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder
The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal…
- Trial name
- DriveSaFe2 (NCT02919579)
- Testing
- Esketamine, Alcohol
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
- Trial name
- NCT00520169
- Testing
- intranasal ketamine
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Acute Pain, Chronic Pain
Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.
Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain.
- Conditions
- Acute Pain, Chronic Pain, Neuropathic Pain
- Trial name
- NCT03105765
- Testing
- Ketamine
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Dr. Horst Schmidt Klinik GmbH
Pharmacokinetics
Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.
- Trial name
- NCT00520104
- Testing
- intranasal ketamine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Healthy
A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine
To investigate the effect of BI 474121 compared to placebo on ketamine-induced cognitive deficits to predict efficacy in patients with cognitive disorders.
- Trial name
- NCT05451095
- Testing
- BI 474121, Ketamine hydrochloride
- Volunteers
- healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.
- Trial name
- NCT04300621
- Testing
- OTF 1, OTF 2, OTF 3
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Treatment Resistant Major Depressive Disorder
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
- Trial name
- ZYL-730-02 (NCT05438758)
- Testing
- Almond Therapy, Intranasal ketamine (Esketamine), Treatment as Usual
- Sponsor
- Zylorion Health
Bipolar Depression, Suicidal Ideas
Sequential Therapy for the Treatment of Severe Bipolar Depression.
NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or…
- Conditions
- Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted
- Trial name
- STABIL-B (NCT02974010)
- Testing
- NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- NeuroRx, Inc.
Procedural Sedation
Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
- Trial name
- NCT04767035
- Testing
- midazolam / ketamine sublingual tablet
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Melt Pharmaceuticals