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AWARE: Management of ADHD in Autism Spectrum Disorder
Daniel Coury
ADHD
Autism Spectrum Disorder
This study is a pragmatic clinical trial examining the comparative effectiveness of two
stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in
children and adolescents with autism. Using a sequential, multiple assignment
randomization trial (SMART) design the study will... expand
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care. Type: Interventional Start Date: Oct 2023 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-DS)... expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
The Role of Estrogen in the Neurobiology of Eating Disorders
Massachusetts General Hospital
Eating Disorders
Hypoestrogenemia
This is a randomized, double blind, placebo-controlled study of the effects of
transdermal estradiol versus placebo on cognitive flexibility, reward processing, and
eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages
14-35 years) with an eating disorder characterized... expand
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments. Type: Interventional Start Date: Jun 2019 |
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
NYU Langone Health
Mild Cognitive Impairment
Alzheimer Disease
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM
in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of
0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham.
At baseline, all subjects will complete... expand
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, ~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Type: Interventional Start Date: Apr 2021 |
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Massachusetts General Hospital
Anxiety Disorder of Childhood
Fear
Shyness
The purpose of this study is to test the feasibility and efficacy of intervening with
2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old
children with elevated anxiety and their parents, using a parent-child Cognitive
Behavioral Therapy (CBT) protocol to reduce anxiety... expand
The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely. Type: Interventional Start Date: Sep 2019 |
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in...
Ionis Pharmaceuticals, Inc.
Amyotrophic Lateral Sclerosis
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical
function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral
sclerosis (FUS-ALS). expand
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS). Type: Interventional Start Date: Jun 2021 |
A Study of TCD601 in de Novo Renal Transplant Recipients
ITB-Med LLC
Renal Transplantation
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination
with Belatacept when compared to standard of care immunosuppression therapy in de novo
renal transplant patients. expand
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients. Type: Interventional Start Date: Dec 2023 |
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid...
Massachusetts General Hospital
Opioid Use
Pain
Marijuana Use
This study will use a randomized controlled design to test whether medical marijuana use
by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is
associated with reduced opioid dose and improved pain intensity and interference when
added to a 24-week behavioral intervention... expand
This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS). Type: Interventional Start Date: Aug 2021 |
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
NYU Langone Health
Major Depressive Disorder
The purpose of this research study is to determine if application of near infrared energy
to the forehead can change blood flow in the brains of people with depression. Near
infrared energy is like light but is not visible to the human eye. expand
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye. Type: Interventional Start Date: Apr 2023 |
Systems Biology of Early Atopy
National Institute of Allergy and Infectious Diseases (NIAID)
Allergic Diseases
Food Allergy
Atopic Dermatitis
The goal of this study is to establish a birth cohort that collects prenatal and early
life biosamples and environmental samples and rigorously phenotypes young children for
food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of
high risk for food allergy and AD, as... expand
The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: - To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years, with an emphasis on atopic dermatitis and food allergy - To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes - To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development Type: Observational Start Date: Mar 2021 |
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric...
Massachusetts General Hospital
Traumatic Brain Injury
Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Attention Deficit Hyperactivity Disorder
In the current study, the investigators aim to understand the role of transcranial direct
current stimulation (tDCS) in improving executive function across neuropsychiatric
populations known to have deficits in this cognitive domain. expand
In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. Type: Interventional Start Date: Sep 2014 |
Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral...
Massachusetts General Hospital
Depression
This is a parallel group study design. The investigators propose to compare an online,
synchronous group-based yoga intervention developed for individuals with depression to an
online, synchronous individualized, evidence-based behavioral therapy for depression, or
Brief Behavioral Activation Treatment... expand
This is a parallel group study design. The investigators propose to compare an online, synchronous group-based yoga intervention developed for individuals with depression to an online, synchronous individualized, evidence-based behavioral therapy for depression, or Brief Behavioral Activation Treatment for Depression (BA). This study is a multi-site randomized trial of adults with clinically significant depressive symptoms. Participants (N=518) will be randomized in an equal allocation ratio (i.e., 1:1) across two intervention groups: yoga and BA. Interventions will be provided over a 12-week period and assessments will occur at baseline (week 0), week 6, week 12, week 18, and week 24. Type: Interventional Start Date: Feb 2023 |