chufangao/CTO huggingface dataset:
Clinical trial NCT03634488: Management of Severe Acute Malnutrition in SCD, in Northern Nigeria
Official title: Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 132.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-18
Primary completion date: 2022-10-05
Completion date: 2022-11-09
Baseline population: Baseline characteristics of participants with sickle cell anemia and severe acute malnutrition by randomization status in the SAMS trial. Baseline characteristics of non-SCD siblings with sickle cell anemia and severe acute malnutrition by randomization status in the SAMS trial.
Limitations and caveats: The sample size for this feasibility study was not determined with the goal of assessing differences in efficacy between the treatment arms. As a feasibility study, the sample size was not based on determining the difference in efficacy of the 2 treatment arms.
Plan to share individual participant data: NO
Clinical trial NCT03971357: Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
Official title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
Sponsor: Price Vision Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: variance of outcome measures was substantially greater than anticipated in the statistical plan
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-22
Primary completion date: 2021-08-26
Completion date: 2021-08-26
Plan to share individual participant data: NO
Clinical trial NCT03603496: Post-Discharge Smoking Cessation Strategies: Helping HAND 4
Official title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Acronym: HH4
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 1416.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-01
Primary completion date: 2020-11-17
Completion date: 2020-11-17
Plan to share individual participant data: NO
Clinical trial NCT02918864: Oxytocin and Social Cognitive Skills Groups
Official title: Integrated Oxytocin and Nonverbal, Emotion Recognition, and Theory of Mind Training for Children With Autism Spectrum Disorder
Acronym: ION-ASD
Sponsor: Rush University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-15
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Limitations and caveats: Enrollment was slowed down during COVID-19 shut down resulting in the study being under-powered and some groups receiving modified protocols. Apriori secondary analyses of maintenance effects resulted in multiple comparisons tests (i.e., at week 16 and 24) which were not corrected to balance type I/type II errors. Additionally, social cognitive stimuli were not counterbalanced; thus, it's unclear whether social cognitive improvements across groups reflect learning or practice effects.
Plan to share individual participant data: YES
IPD sharing description: Data from this study may be submitted to the National Database for Autism Research (NDAR), a computer system run by the National Institutes of Health that allows researchers studying autism to collect and share information. Data will be shared with study collaborators as well.
Clinical trial NCT02900352: Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action
Official title: Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action
Acronym: Z-Comp
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 156.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2021-04-22
Completion date: 2021-04-22
Baseline population: Alcohol Use Disorder Treatment Seekers
Plan to share individual participant data: NO
Clinical trial NCT04530344: Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Official title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 458.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-24
Primary completion date: 2022-11-14
Completion date: 2022-11-14
Limitations and caveats: Data from participants at a single site (N = 2) were removed from all efficacy analyses performed on the ITT-Ext Population and FAS Cohort A owing to noncompliance with the Protocol in the parent study resulting in serious concerns with data quality.
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT02899611: A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures
Official title: A Dose Ranging Pilot Study to Assess Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
Sponsor: Cerebral Therapeutics LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2021-06-01
Completion date: 2021-06-01
Plan to share individual participant data: NO
Clinical trial NCT04858620: A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Official title: A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Sponsor: Larkin Community Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study Period Ended / Not Completed
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-30
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Clinical trial NCT04804254: Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers
Official title: A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 5.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-04-27
Primary completion date: 2023-01-11
Completion date: 2023-01-11
Plan to share individual participant data: NO
Clinical trial NCT03048422: Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
Official title: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
Acronym: VESTED
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 643.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-01-19
Primary completion date: 2020-10-03
Completion date: 2020-10-03
Baseline population: Enrolled women.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH
IPD access criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Clinical trial NCT04610684: Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases
Official title: Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomatic Brain Metastases
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of Enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-05
Primary completion date: 2022-07-15
Completion date: 2022-09-20
Plan to share individual participant data: NO
Clinical trial NCT04789408: Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia
Official title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study was terminated due to futility
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-19
Primary completion date: 2024-05-18
Completion date: 2024-05-18
Plan to share individual participant data: NO
Clinical trial NCT01924533: Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Official title: A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 525.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-03
Primary completion date: 2016-04-04
Completion date: 2023-03-27
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04155424: A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder
Official title: A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Pediatric clinical study is not feasible.
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-14
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Baseline population: Safety Set included all participants who received at least 1 dose of eculizumab.
Limitations and caveats: The study was terminated by Alexion, as only 5 of the planned 12 participants were enrolled due to difficulty in recruitment.
Plan to share individual participant data: NO
Clinical trial NCT03159936: Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Official title: Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Sponsor: Tufts Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: unable to identify additional subjects to qualify for enrollment
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-03
Primary completion date: 2020-05-13
Completion date: 2020-06-10
Plan to share individual participant data: NO
Clinical trial NCT04653194: Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
Official title: Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
Acronym: BIC-T&T
Sponsor: Chelsea and Westminster NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-07-30
Completion date: 2023-07-31
Plan to share individual participant data: NO
Clinical trial NCT04730947: Dapagliflozin (DAPA) Effects in HFpEF
Official title: Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-24
Primary completion date: 2022-11-17
Completion date: 2022-11-17
Plan to share individual participant data: NO
Clinical trial NCT04176913: Study of LUCAR-20S in Patients With R/R NHL
Official title: A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LUCAR-20S in Patients With Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma
Sponsor: The First Affiliated Hospital with Nanjing Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Both the sponsors and collaborator are considering terminating the study
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-01
Primary completion date: 2021-12-09
Completion date: 2021-12-09
Clinical trial NCT04318444: Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)
Official title: Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The Institutional Review Board closed the study
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-29
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Baseline population: 2 out of 10 consented participants withdrew consent prior to initiating study intervention.~Due to the low number of participants per group, baseline characteristics are presented as one arm to protect the confidentiality of the participants.
Plan to share individual participant data: NO
Clinical trial NCT04843319: To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer
Official title: Open-Label, Proof-of-Concept and Dose Finding Phase 1b/2 Study of VERU-100 in Men With Advanced Prostate Cancer
Acronym: VERU-100
Sponsor: Veru Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated as end points were not achieved at current dose level.
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-09
Primary completion date: 2023-01-19
Completion date: 2023-01-19
Plan to share individual participant data: NO
Clinical trial NCT04649515: Efficacy and Safety of TY027, a Treatment for COVID-19, in Humans
Official title: Phase 3 Multi-Site, Randomised, Placebo Controlled, Double Blind, Single Dose Study of TY027 for Early Treatment of COVID-19
Sponsor: Tychan Pte Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low recruitment rate
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-04
Primary completion date: 2022-03-04
Completion date: 2022-03-04
Plan to share individual participant data: NO
Clinical trial NCT04974359: A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia
Official title: Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to enrolment challenges.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-24
Primary completion date: 2022-01-26
Completion date: 2022-01-26
Clinical trial NCT03777059: 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 910.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-12-14
Primary completion date: 2020-06-19
Completion date: 2020-06-19
Baseline population: Safety Population included all participants who received at least 1 dose of study intervention.
Clinical trial NCT03793712: Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-flexible-dose Study of Lu AF11167 for the Treatment of Persistent Prominent Negative Symptoms in Patients With Schizophrenia
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy based on interim analysis
Enrollment: 168.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-27
Primary completion date: 2020-08-20
Completion date: 2020-09-03
Plan to share individual participant data: UNDECIDED
Clinical trial NCT01997840: ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
Official title: A Phase 1B/2 Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (RICOLINOSTAT) in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 103.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-01
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Clinical trial NCT04443569: Lidocaine Patches After Cesarean Section
Official title: Lidocaine Patches After Cesarean Section
Acronym: LPACS
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-10
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
Clinical trial NCT06049329: A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-09-14
Primary completion date: 2023-12-15
Completion date: 2023-12-15
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03952481: Effect of Lifitegrast 5% on Tear Film Markers
Official title: Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: COVID restrictions
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-01
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04161118: TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Official title: Phase II Trial of TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Acronym: TIGER-CTL019
Sponsor: University of Cologne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Termination of the funding agreement by the financial sponsor of the study. Small number of patients enrolled, none of the planned analyses will be feasible to draw conclusions on the safety or efficacy of the therapy.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-12
Primary completion date: 2023-02-24
Completion date: 2023-02-24
Plan to share individual participant data: NO
Clinical trial NCT02397889: Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
Official title: Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-18
Primary completion date: 2020-01-27
Completion date: 2020-01-27
Limitations and caveats: Exclusion of patients with comorbid psychotic, bipolar, or current alcohol or substance use disorders to protect against worsening of psychotic symptoms or abuse potential, which may limit generalizability of our findings to individuals with PTSD and these comorbid disorders.
Plan to share individual participant data: NO