CLINICAL PHARMACOLOGY AND TARGET VALIDATION OF A BIOACTIVE DIETARY POLYPHENOL PREPARATION (BDPP) FOR STRESS-RELATED DISORDERS
PI: James Murrough, MD, PhD
Study Coordinator: Maxine Marchidan
Funding: National Institutes of Health (NIH)/National Center for Commentary and Integrative Health (NCCIH)
Description: The current study will assess the clinical pharmacology of BDPP in healthy subjects treated with three doses of BDPP (low, intermediate and high dose) and evaluate the effect of BDPP on blood levels of inflammatory cytokines, in particular IL-6, at baseline and in response to acute stress.
Inclusion: Participants will be males or females aged 18-55 years, with a body max index (BMI) less than 30.
Exclusion: Any psychiatric diagnosis as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); substance or alcohol use disorder in the past 2 years; any unstable medical illnesses; any diagnosed inflammatory or autoimmune disorder; clinically significant abnormalities of laboratory tests; use of medication or nutritional supplement known to affect inflammation and polyphenol levels; or female participants who are pregnant or nursing or plan to become pregnant.
Study Participation Length: Subjects will be on study for up to 10 weeks.
Compensation: Yes
A Dose Escalation Study of Harmine in Healthy Subjects
PI: James Murrough, MD, PhD
Study Coordinator: Leah Israel
Funding: Internal Funds
Description: This study is designed to investigate the safety of oral administration of harmine using an open label, two-stage, continual reassessment method with 8 doses of harmine at 100mg, 200mg, 300mg, 500mg, 700mg, 900mg and 1200mg in healthy volunteers. We anticipate that the proposed study will yield the maximum tolerated dose (MTD) for harmine, which will guide future research efforts toward novel diabetes treatments.
Inclusion: Healthy adults; Men and Women, age 21-55; 110-220lbs
Exclusion:
- Acute or severe medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry.
- Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. MS
- Presence or history of psychiatric disorder as diagnosed by MINI or SCID
Study Participation Length: Three visits
Compensation: Yes
Cognitive Neuroscience of Mood and Anxiety Disorders
PI: James Murrough, MD, PhD
Study Coordinator: Abigail Adams
Funding: Internal Funds
Description: We aim to conduct a set of cognitive and clinical assessments, and high-resolution MRI-based neural
measurements in subjects with mood and anxiety disorders, with the aim of fully phenotyping these individuals. Understanding the cognitive and neural features of these patients will inform biomarkers that will potentially predict treatment outcome that may lead to more effective, targeted therapies. This will be crucial for reducing the health, social and economic costs of these costly treatments. Our project has the potential to have a major public health impact to advance diagnostic and treatment efficacy for precision medicine for subjects suffering from mood and anxiety disorder
Inclusion: Male or female aged 18-75 years; 1. Meets DSM-V criteria for major depressive disorder (MDD), persistent depressive disorder, other specified depressive disorder, Post Traumatic Stress Disorder, or anxiety disorders (including Generalized Anxiety Disorder, Social
Anxiety Disorder, and Panic Disorder) as determined by the Structured Clinical Interview for DSM-V Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI) OR 2.Does not meet for any current or past psychiatric diagnoses
Exclusion: Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive
disorder for patients and for healthy control subjects: any current or lifetime psychiatric disorder ; Active substance use disorder within the past 1 year; Positive urine toxicology screen for drugs of abuse at the time ofscreening*; Any unstable medical illnesses; Women who are pregnant; ; Any contraindications to MRI
Study Participation Length: Includes screening and one scanning visit
Compensation: Yes
Using Digital Technology to Monitor Mood and Anxiety Disorders
PI: Laurel Morris, PhD
Study Coordinator: Abigail Adams
Funding:
Description: We aim to evaluate how smartphone-based assessments of mood, cognitive performance, mobility, sociability, and
physiology compare to gold-standard in-person clinical assessments and clinical symptoms related to mood. By demonstrating the validity
of real-world smartphone-based assessments, we will provide tools that can measure behavioral features that could predict symptom
progression and treatment outcome that may lead to more effective, targeted therapies. This will be crucial for reducing the health, social
and economic costs of costly treatments. Our project has the potential to have a major public health impact to advance diagnostic and
treatment efficacy for precision medicine for subjects suffering from mood and anxiety disorders
Inclusion: Male or female aged 18-75 years; Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria as determined by the Structured Clinical Interview for DSM-V Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
Exclusion: Does not speak English ; Does not own a smartphone that can run the study applications (Android or Apple
Study Participation Length: Three visits
Compensation: Yes