Clinical trials: Molecular Mechanisms of Pharmacological Action
Suicide, Depressive Disorder, Treatment-Resistant
Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression
Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective.
- Conditions
- Suicide, Depressive Disorder, Treatment-Resistant, Ketamine, Molecular Mechanisms of Pharmacological Action
- Trial name
- NCT06511908
- Testing
- (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Mental Health (NIMH)
Behavioral Symptoms, Suicide
Natural History of Depression, Bipolar Disorder and Suicide Risk
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments.
- Conditions
- Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents
- Trial name
- NCT06462196
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Mental Health (NIMH)
Neuromuscular Agents, Peripheral Nervous System Agents
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence.
- Conditions
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors
- Trial name
- PLATINUM US (NCT07122193)
- Testing
- NT 201
- Where
- 28 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Merz North America, Inc.
Neuromuscular Agents, Peripheral Nervous System Agents
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence.
- Conditions
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors
- Trial name
- PLATINUM EU (NCT07210463)
- Testing
- NT 201
- Where
- 26 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Merz Aesthetics GmbH
Melanoma, Unresectable Solid Tumors
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Nivolumab (and other agents affecting the anti-programmed death-1 [anti-PD-1] pathway) have demonstrated anti-tumor activity in multiple tumor types.
- Conditions
- Melanoma, Unresectable Solid Tumors, Neoplasms, Neoplasms by Histologic Type
- Trial name
- NCT04572451
- Testing
- nivolumab, BMS-986253, Stereotactic Body Radiotherapy (SBRT)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yana Najjar
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Delirium, Cognitive Dysfunction
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated.
- Conditions
- Delirium, Cognitive Dysfunction, Cognition Disorder, Neurocognitive Disorders
- Trial name
- CODEX (NCT04289142)
- Testing
- Dexmedetomidine Hydrochloride Group
- Where
- 8 sites in Canada
- Volunteers
- 2,400 people
- Sponsor
- Sunnybrook Health Sciences Centre
Breast Cancer, Neoplasm, Breast
Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)
Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020.
- Conditions
- Breast Cancer, Neoplasm, Breast, Breast Diseases, Antihypertensive Agents
- Trial name
- NCT05465031
- Testing
- Sacubitril-valsartan
- Where
- 4 sites in Poland
- Volunteers
- 600 people
- Sponsor
- Silesian Centre for Heart Diseases
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Type 2 Diabetes
Antidiabetic Drugs for Steatotic Liver Disease
To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on metabolic dysfunction-associated steatotic liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination…
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Type 2 Diabetes, Digestive System Disease, Liver Diseases
- Trial name
- NCT03646292
- Testing
- Pioglitazone, Empagliflozin, Combination of pioglitazone and empagliflozin
- Where
- South Korea
- Volunteers
- 51 people
- Sponsor
- Yonsei University
Prader-Willi Syndrome, Aggression
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS).
- Conditions
- Prader-Willi Syndrome, Aggression, Self-Injurious Behavior, Pathologic Processes
- Trial name
- PWS-GXR (NCT05657860)
- Testing
- Guanfacine Extended Release
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Maimonides Medical Center
Hepatocellular Carcinoma, Liver Neoplasms
TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC
Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death that ranks sixth in terms of incident cases, with an overall 5 years survival of 18%.
- Conditions
- Hepatocellular Carcinoma, Liver Neoplasms, Digestive System Neoplasms, Sorafenib
- Trial name
- NCT04518852
- Testing
- TACE combined with sorafenib and PD-1 mAb
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Sichuan Cancer Hospital and Research Institute
Schizophrenia, Psychotic Disorders
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- Trial name
- NCT05321602
- Testing
- LY03010 156 mg treatment group, deltoid, LY03010 156 mg treatment group, gluteal, LY03010 351 mg treatment group, deltoid
- Where
- 9 sites in United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Psychotic Disorders
Relative Bioavailability of LY03010 Compared to Listed Drug
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum
- Trial name
- NCT04922593
- Testing
- LY03010; paliperidone palmitate, INVEGA SUSTENNA
- Where
- 9 sites in United States
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Molecular Mechanisms of Pharmacological Action, Depression
Effects of Seven Day Prucalopride Administration in Healthy Volunteers
This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to…
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders
- Trial name
- NCT03572790
- Testing
- Prucalopride
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Stroke, Cerebrovascular Disorders
Propranolol on Post Stroke Immune Status and Infection
Stroke-associated pneumonia (SAP) is one of the important risk factors influencing poor outcomes and death in stroke patients. Over the past two decades, accumulating evidence suggests that post-stroke brain injury mobilizes the…
- Conditions
- Stroke, Cerebrovascular Disorders, Ischemic Stroke, Brain Diseases
- Trial name
- NCT05375240
- Testing
- Propranolol, Ceftriaxone
- Where
- 2 sites in China
- Volunteers
- 45 people
- Sponsor
- Tianjin Medical University General Hospital
Tobacco Dependence, Smoking Cessation
Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence
The addition of tDCS as an adjunct to pharmacotherapy is a novel approach but one that is grounded in a growing evidence-base.The primary objective of this research is to provide preliminary evidence of the effectiveness of tDCS…
- Conditions
- Tobacco Dependence, Smoking Cessation, Tobacco Smoking, Tobacco Use Disorder
- Trial name
- NCT03841292
- Testing
- Varenicline, Active tDCS
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- Centre for Addiction and Mental Health
Ovarian Neoplasms, Fallopian Tube Neoplasms
Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy.
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endocrine Gland Neoplasms, Neoplasms by Site
- Trial name
- AVANIRA3 (NCT04556071)
- Testing
- Niraparib, Bevacizumab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Xiaoxiang Chen
Pharmacokinetics, Molecular Mechanisms of Pharmacological Action
Pharmacometabolomics of Andrographis Paniculata And Metformin In Healthy Volunteers Under Fasting Condition
This study is a phase 1, open label, randomized, three-way crossover, single dose, oral- administration of Andrographis paniculata and Metformin in healthy volunteers under fasting condition.
- Trial name
- NCT04161404
- Testing
- Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg, Metformin (Glucophage) 1000mg
- Where
- Malaysia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Malaya
Molecular Mechanisms of Pharmacological Action, Depression
Citalopram and Self Emotional Processing
This study is investigating the effect of an acute dose of citalopram on emotional processing about the self. Using a parallel-group double-blind design, participants will be randomised to receive either an acute dose of…
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mental Disorder
- Trial name
- NCT04169230
- Testing
- Citalopram
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Oxford