| Caplyta (lumateperone) / Intra-Cellular Therapies |
NCT06174116: Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia |
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| Recruiting | 4 | 50 | US | Lumateperone, Caplyta, Placebo | University of Massachusetts, Worcester, Intra-Cellular Therapies, Inc. | Schizophrenia, Schizo Affective Disorder | 08/26 | 11/26 | | |
| Terminated | 4 | 5 | US | Lumateperone, Caplyta, Risperidone, Risperdol | University of New Mexico | Psychosis | 02/24 | 02/24 | | |
2018-002749-12: Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression |
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| Not yet recruiting | 3 | 514 | Europe | ITI-007, Capsule | Intra-Cellular Therapies, Inc. (ITI), Intra-Cellular Therapies, Inc. (ITI) | Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression), Bipolar Depression, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2021-001192-17: A Study to Assess the Efficacy and Safety of Lumateperone as Add on Therapy in the Treatment of Patients with Major Depressive Disorder |
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| Not yet recruiting | 3 | 470 | RoW, Europe | Lumateperone, ITI-007, Capsule | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2021-002068-30: Study of Lumateperone for the Prevention of Relapse in Patients with Schizophrenia |
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| Not yet recruiting | 3 | 800 | Europe | Lumateperone, ITI-007, Capsule, Caplyta | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Schizophrenia, Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2021-001172-41: A Study to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
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| Not yet recruiting | 3 | 760 | RoW, Europe | Lumateperone, ITI-007, Capsule, CAPLYTA | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2021-001212-29: A Study to Assess the Efficacy and Safety of Lumateperone as Add on Therapy in the Treatment of Patients with Major Depressive Disorder |
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| Not yet recruiting | 3 | 470 | Europe, RoW | Lumateperone, ITI-007, Capsule | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
NCT04285515 / 2019-004440-29: Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder |
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| Completed | 3 | 488 | Europe, US, RoW | Lumateperone, Placebos | Intra-Cellular Therapies, Inc. | Bipolar Depression, Major Depressive Disorder | 11/22 | 11/22 | | |
| Completed | 3 | 228 | Europe, US, RoW | Lumateperone 42 mg, Placebo | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Schizophrenia | 07/24 | 08/24 | | |
NCT06229210: Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder |
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| Recruiting | 3 | 500 | US | Lumateperone | Intra-Cellular Therapies, Inc. | Schizophrenia, Bipolar Disorder | 12/27 | 12/27 | | |
| Completed | 3 | 485 | Europe, US, RoW | Lumateperone, Placebo | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder | 02/24 | 02/24 | | |
| Completed | 3 | 480 | Europe, US, RoW | Lumateperone, Placebo | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder | 04/24 | 04/24 | | |
NCT05061719 / 2021-001172-41: An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
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| Completed | 3 | 812 | Europe, US, RoW | Lumateperone | Intra-Cellular Therapies, Inc., Intra-Cellular Therapies, Inc. | Major Depressive Disorder | 10/24 | 10/24 | | |
NCT06372964: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients |
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| Recruiting | 3 | 384 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Depression | 04/27 | 05/27 | | |
NCT06482554: Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms. |
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| Recruiting | 3 | 80 | US | Lumateperone 42 mg, Lumateperone, Risperidone 2 mg, olanzapine; quetiapine; ziprasidone; aripiprazole | Louisiana State University Health Sciences Center Shreveport | Apathy, Schizophrenia, Schizophrenia; Psychosis | 12/26 | 12/26 | | |
NCT06462586: Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania |
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| Recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 03/26 | 04/26 | | |
NCT06462612: Study of Lumateperone in the Treatment of Patients With Bipolar Mania |
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| Recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 05/26 | 06/26 | | |
NCT06690398: Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients |
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| Recruiting | 3 | 174 | US | Lumateperone high dose, Lumateperone low dose, Placebo | Intra-Cellular Therapies, Inc. | Irritability Associated With Autism Spectrum Disorder | 03/27 | 04/27 | | |
ITI-007-602, NCT06706674: Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients |
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| Recruiting | 3 | 174 | US | Lumateperone high dose, Lumateperone low dose, Placebo | Intra-Cellular Therapies, Inc. | Irritability Associated With Autism Spectrum Disorder | 03/27 | 04/27 | | |
NCT05850689: Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
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| Recruiting | 3 | 470 | Europe, US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Major Depressive Disorder | 09/26 | 10/26 | | |
2007-004640-78: A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia |
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| Ongoing | 2 | 36 | Europe | ITI-007, | Intra-Cellular Therapies, Inc | Sleep maintenance disorders | | | | |
| Recruiting | 2 | 60 | US | Caplyta, lumateperone, Placebo, no other names | University of Chicago, Intra-Cellular Therapies, Inc. | Borderline Personality Disorder | 05/25 | 05/25 | | |
NCT06557902: Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder |
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| Recruiting | 1 | 26 | US | Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT, Lumateperone 10.5 mg ODT, Lumateperone 15.5 mg ODT, Lumateperone 21 mg ODT | Intra-Cellular Therapies, Inc. | Autism Spectrum Disorder | 07/26 | 07/26 | | |
| piracetam / Generic mfg. |
ChiCTR2000034474: Clinical observation of piracetam injection in the treatment of cerebral infarction patients |
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| Not yet recruiting | 4 | 360 | | piracetam injection | Zhujiang Hospital of Southern Medical University; Zhujiang Hospital of Southern Medical University, sponsor | Cerebral infarction | | | | |
ChiCTR2000040466: A randomized, blinding, parallel controlled, multicenter clinical trial of compound procine cerebroside and ganglioside injection in the treatment of craniocerebral injury |
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| Recruiting | 4 | 900 | | compound procine cerebroside and ganglioside injection; Piracetam Injection | Tianjin Medical University General Hospital; Tianjin Medical University General Hospital, Jilin Tiancheng Pharmaceutical Co., Ltd | craniocerebral injury | | | | |
NCT05918341: Subtherapeutic Dose of Piracetam as a Therapy Adherence Marker |
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| Not yet recruiting | 4 | 10 | NA | Piracetam | The Netherlands Cancer Institute | Drug Adherence Marker | 09/23 | 09/23 | | |
| Not yet recruiting | 4 | 60 | NA | Piracetam, no other interventions, Placebo | Ain Shams University, King Salman International university | Diabetic Peripheral Neuropathy | 11/25 | 11/25 | | |
2005-005460-80: A single center, randomized, open-label, comparative study to assess efficacy and safety of piracetam 4.8g/d administered for 6 months as adjuvant to standard vestibular rehabilitation (VR) therapy utilizing Cooksey Cawthorne exercises to adults suffering from moderate to severe vertigo of peripheral origin lasting for at least 3 months. |
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| Ongoing | 2 | 50 | Europe | Nootrop, | N/A | moderate to severe vertigo of peripheral origin | | | | |
ChiCTR2400083497: A study on the impact of EEG biofeedback therapy on cognitive function in patients with non dementia vascular cognitive impairment |
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| Recruiting | 1 | 76 | | On the basis of routine treatment and nursing, combined with EEG biofeedback adjuvant therapy, once a day, 30 minutes each time, 5 times a week, a total of 10 times (intervention for 4 weeks).; Routine treatment includes: controlling blood pressure, regulating blood sugar, regulating lipid metabolism, nourishing nerves, and improving circulation, while administering drugs that improve cognitive function such as ibuprofen soft capsules, piracetam capsules, and donepezil hydrochloride Routine care: such as admission guidance, dietary care, medication guidance, primary rehabilitation gymnastics guidance, psychological care, and discharge rehabilitation guidance. | Affiliated Hospital of North Sichuan Medical College; Affiliated Hospital of North Sichuan Medical College, Hospital provide their own supplies | vascular cognitive impairment no dementia | | | | |
NCT06689644: Effect of a Plant Based Nootropic on Perceptual Decision Making. |
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| Completed | N/A | 37 | Europe | Nootropics (ginkgo biloba, nicergoline, piracetam, or others), Placebo, Perceptual decision-making performance, Electroencephalography | University of Leeds | Cognitive Enhancement | 03/24 | 06/24 | | |
| apimostinel IV (GATE-202) / Gate Neurosciences |
NCT06400121: Apimostinel + Automated Neurocognitive Training for Depression |
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| Recruiting | 2 | 150 | US | Apimostinel Infusion, Intravenous, Cognitive Training, Sham Training, Isotonic Solution, Intravenous | Rebecca Price, Gate Neurosciences, Inc | Depression | 03/29 | 12/29 | | |
NCT05597241: Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers |
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| Completed | 1 | 40 | US | apimostinel, GATE-202, Placebo | Gate Neurosciences, Inc | Major Depressive Disorder | 04/23 | 04/23 | | |
| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen |
SBD-ASIB, NCT03396068: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation |
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| Active, not recruiting | 3 | 72 | US | NRX-101, Cyclurad, Lurasidone HCl | NeuroRx, Inc., Target Health Inc. | Bipolar Depression, Suicidal Ideation | 12/24 | 12/24 | | |
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| Completed | 2/3 | 74 | US | NRX-101, Lurasidone HCl, Latuda | NeuroRx, Inc., Prevail Infoworks, Inc | Bipolar Depression, Suicidal Ideation and Behavior | 02/24 | 03/24 | | |
NCT06128213: NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis |
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| Not yet recruiting | 2 | 13 | NA | NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) | NeuroRx, Inc. | Urinary Tract Infections, Pyelonephritis | 06/24 | 09/24 | | |
| Available | N/A | | NA | NRX-101 | NeuroRx, Inc., Prevail Infoworks | Bipolar Depression, Bipolar Affective Disorder | | | | |
| soticlestat (TAK-935) / Takeda |
| Completed | 3 | 270 | Europe, Canada, Japan, US, RoW | Placebo, Soticlestat, TAK-935 | Takeda | Lennox Gastaut Syndrome (LGS) | 01/24 | 01/24 | | |
| Completed | 3 | 144 | Europe, Canada, Japan, US, RoW | Soticlestat, TAK-935, Placebo | Takeda | Dravet Syndrome (DS) | 04/24 | 04/24 | | |
TAK-935-3004, NCT06422377: A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine |
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| Terminated | 3 | 1 | Europe | Soticlestat, TAK-935 | Takeda | Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS) | 08/24 | 08/24 | | |
| Recruiting | 3 | 400 | Europe, Canada, Japan, US, RoW | Soticlestat, TAK-935 | Takeda | Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS) | 05/26 | 05/26 | | |
2018-002485-39: A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEPSY Estudio de extensión de fase 2, prospectivo, intervencionista, abierto y multicéntrico para evaluar la seguridad y tolerabilidad a largo plazo de TAK-935 como tratamiento complementario en pacientes con epilepsia rara |
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| Ongoing | 2 | 176 | Europe, RoW, Canada, US | TAK-935, TAK-935, Tablet | Ovid Therapeutics, Inc., Takeda Development Center Americas, Inc., Ovid Therapeutics, Inc., Takeda Development Center Americas, Inc., Takeda Development Center Americas, Inc | developmental and epileptic encephalopathies encefalopatías epilépticas y del desarrollo, developmental and epileptic encephalopathies encefalopatías epilépticas y del desarrollo, Diseases [C] - Nervous System Diseases [C10] | | | | |
2018-002484-25: A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged ≥2 and ≤17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut) |
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| Not yet recruiting | 2 | 126 | Europe | TAK-935, Tablet | Takeda Development Center Americas, Inc., Takeda Development Center Americas, Inc. | Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS), Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS), Diseases [C] - Nervous System Diseases [C10] | | | | |
2018-004750-21: Study of TAK-935 as an Adjunctive Therapy in Adult Subjects With Complex Regional Pain Syndrome |
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| Not yet recruiting | 2 | 24 | Europe | TAK-935, TAK-935, Tablet | Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda, Millennium Pharmaceuticals | Complex Regional Pain Syndrome (CRPS), Complex Regional Pain Syndrome (CRPS), Diseases [C] - Nervous System Diseases [C10] | | | | |
| Active, not recruiting | 2 | 156 | Europe, Canada, US, RoW | Soticlestat, TAK-935 | Takeda, Ovid Therapeutics, Inc., Takeda Development Center Americas, Inc., Takeda Development Center Americas, Inc | Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS) | 05/26 | 05/26 | | |
NCT05602818: A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience |
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| Completed | 1 | 100 | US | Soticlestat 300 mg, Soticlestat 600 mg, Soticlestat 900 mg, Alprazolam, Placebo | Takeda | Healthy Volunteers | 06/23 | 07/23 | | |
| zelquistinel (GATE-251) / Gate Neurosciences |
NCT06547489: GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder |
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| Recruiting | 2 | 164 | US | Zelquistinel, GATE-251 | Gate Neurosciences, Inc, Worldwide Clinical Trials | Major Depressive Disorder | 08/26 | 12/26 | | |
| dalzanemdor (SAGE-718) / Sage Therapeutics |
NCT05655520: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease |
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| Terminated | 3 | 153 | Canada, US | SAGE-718 | Sage Therapeutics | Huntington's Disease | 01/25 | 01/25 | | |
NCT05318937: A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment |
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| Completed | 2 | 86 | US | SAGE-718, SAGE-718-matching placebo | Sage Therapeutics | Parkinson Disease, Cognitive Dysfunction | 01/24 | 02/24 | | |
NCT05358821: 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease |
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| Completed | 2 | 69 | US | SAGE-718, Placebo | Sage Therapeutics | Huntington Disease | 02/24 | 04/24 | | |
DIMENSION, NCT05107128: A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD) |
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| Completed | 2 | 189 | Europe, Canada, US, RoW | SAGE-718, Placebo | Sage Therapeutics | Huntington's Disease | 09/24 | 10/24 | | |
718-CNA-202, NCT05619692: A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD) |
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| Completed | 2 | 174 | US | SAGE-718, SAGE-718-matching Placebo | Sage Therapeutics | Mild Cognitive Impairment, Mild Dementia, Alzheimer's Disease | 06/24 | 07/24 | | |
| long-acting lumateperone (ITI-007 LAI) / Intra-Cellular Therapies |
NCT06627413: Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder |
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| Recruiting | 1 | 72 | US | Lumateperone Capsule, Lumateperone LAI | Intra-Cellular Therapies, Inc. | Schizophrenia or Schizoaffective | 02/26 | 03/26 | | |
| Kindolor (Lohocla 201) / Lohocla Research |
NCT06243835: A Study to Test the Effects of Kindolor At Different Doses in Healthy Adults |
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| Active, not recruiting | 1 | 32 | US | Kindolor Tosylate, DCUKA, Placebo, Placebo to Match | Lohocla Research Corporation, National Institute on Drug Abuse (NIDA) | Chronic Pain | 07/25 | 07/25 | | |
| DAAOI-P / China Medical University Hospital |
NCT04470037: Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder |
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| Recruiting | 2 | 60 | RoW | DAAOI-P, Placebo | China Medical University Hospital, Ministry of Science and Technology, Taiwan | Parkinson's Disease With Dementia | 12/24 | 03/25 | | |
| RL-007 / atai Life Sci |
NCT05686239: A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) |
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| Recruiting | 2 | 234 | Europe, US, RoW | RL-007, Placebo | Recognify Life Sciences | Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia | 06/25 | 07/25 | | |
| 2R,6R-hydroxynorketamine hydrochloride ((2R,6R)-HNK) / National Institute of Mental Health |
NCT06511908: Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression |
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| Recruiting | 2 | 50 | US | (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg), Placebo | National Institute of Mental Health (NIMH) | Suicide, Depressive Disorder, Treatment-Resistant, Ketamine, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Excitatory Amino Acid Agents, Physiological Effects of Drugs, Depressive Disorder, Major, Depressive Disorder, Depression, Mental Disorders, Mood Disorders, Behavioral Symptoms | 07/27 | 07/27 | | |
NCT04711005: Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine |
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| Completed | 1 | 74 | US | (2R,6R)-Hydroxynorketamine hydrochloride, Placebo | National Institute of Mental Health (NIMH) | Major Depressive Disorder | 04/23 | 05/23 | | |
