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A Translational and Neurocomputational Evaluation of a D1R Partial Agonist for Schizophrenia

The purpose of this research is to test an experimental drug CVL-562 as a possible treatment for early-course schizophrenia, schizoaffective disorder or related psychotic disorder.

This study will test whether CVL-562 can help thinking and memory in people with schizophrenia.

Basic Inclusion:

Ages 18 – 45 years old.

Procedures:

  • Clinical interviews
  • Clinical and cognitive assessments 
  • Medical assessments (e.g., physical exam, bloodwork, urine pregnancy and drug testing, EKG)
  • Neuroimaging and behavioral tasks
  • Compliance with an experimental medication

Duration:

Participation may last between 1 and 2 months. There will be a total of 7 study visits (the first visit may be spread across a few days), 5 visits would be considered test days involving study treatment with the experimental medication (CVL-562) in which you will receive a randomized dose. There will be one follow-up visit approximately one month after the last test day visit.

Study participants will be compensated for their time and travel.

Primary Investigator:

Raquel Gur, M.D.,Ph.D.

UPenn_TRANSCENDS_FLYER_7-2-2020_Tom.pdf

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Schizophrenia Spectrum Biomarkers Consortium (SSBC)

The purpose of our overall research study is to identify biological markers for schizophrenia and related mental illnesses. We are gathering mental health information, brain images, cells and genetic material (DNA), as well as blood and cerebrospinal fluid (CSF) from persons who appear to have a psychiatric disorder and those who do not. We would like to identify measurable differences that could help doctors identify people who are developing a psychiatric disorder or help us better understand why some patients respond better to treatment than others. 

For this study, we are looking for:

  • Individuals between the ages of 18 and 40 who have been diagnosed with schizophrenia-spectrum disorders (schizophrenia, schizoaffective disorder or schizophreniform disorder)

  • Individuals at clinical high risk for schizophrenia between the ages of 18 and 30

  • Healthy comparison individuals between the ages of 18 and 40

Participants in this study will complete:

  • Questionnaires about life experiences and medical history

  • A brief physical exam

  • Neurological assessment

  • Brain imaging

  • Collection of blood, urine, and cerebrospinal fluid (CSF) via lumbar puncture

Study participants will be compensated for their time and travel expenses.

Please visit https://ssbcbio.org for more information.

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Evolution of Psychosis in Youth

 The purpose of this study is to examine the effects of genes and the environment on brain development and behavior.

Basic Inclusion Criteria:

  • Ages 15 – 30
  • The study will enroll four groups: individuals with low genetic risk for psychosis and low environmental risk, individuals with low genetic risk for psychosis and high environmental risk, individuals with high genetic risk for psychosis and low environmental risk, and individuals with high genetic risk for psychosis risk and high environmental risk.

Procedures:

  • The research study includes:
  • Clinical assessment
  • Neurocognitive assessment
  • Questionnaires about moods and feelings
  • Blood draw
  • MRI scan

Duration:

Approximately 6 hours.

Participants will be compensated for their time and reimbursed for any parking or transportation expenses.

Primary Investigator:

Raquel Gur, M.D., Ph.D.

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Rare CNV

This research aims to better understand brain and behavioral differences in individuals who have a diagnosis of 22q11.2 or 16p11.2 deletions (Del) or duplications (Dup) and their relatives.

Additional Info:

The International Consortium on Brain and Behavior Copy Number Variants (IBBC-CNVs) is a collaborative effort of nine institutions with complementary experience and expertise in phenomics and genomics.

Basic Inclusion Criteria:

  • Ages 7 and up with a diagnosis of 22q11.2 or 16p11.2 deletions (Del) or duplications (Dup) and their relatives.

Study Procedures:

  • Computerized Neurocognitive Battery

  • Interview with either just participant (if 18 or older) or participant and a parent or guardian if under 18

  • Blood sample

Duration:

Approximately 4 hours

Participants will be compensated for their time and reimbursed for any parking or transportation expenses.

Primary Investigator:

Raquel Gur, M.D., Ph.D.

For more information about this study, please call Sean Gallagher at 215-906-5071

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Melatonin, Sleep and Mental Health

This study seeks to understand how sleep affects mental health.

Inclusion and Exclusion Criteria:

  • Ages 11 to 30
  • Mild sleep problems
  • Have had unusual experiences like having your mind play tricks on you, having jumbled up thoughts, seeing or hearing things other people didn’t, or having beliefs that most people around you didn’t have

Study Procedures:

  • Memory and attention tests
  • An interview about your life experiences, thoughts, feelings and aspects of mental health
  • Collection of family and medical history
  • Urine samples and optional blood draw
  • Information collected from participants and parents (when applicable)
  • Optional medication trial - taking an over-the-counter melatonin pill or placebo for 2 weeks

Duration:

The study includes 2 visits one week apart. Each visit is about 4 hours. If a participant agrees to do the medication trial, there are 2 additional visits.

Participants will be compensated for their time and reimbursed for any parking or transportation expenses.

Primary Investigator:

Jerome Taylor, M.D.

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Adolescent Brain Development, Memory, and Motivation

This study is examining motivation in adolescents and young adults to study how brain development affects this process.

Basic Inclusion Criteria:

  • Ages 16 to 26

Procedures:

  • Clinical assessment
  • Neurocognitive assessment
  • Questionnaires about moods and feelings
  • MRI scan

Duration:

4 visits in total over the course of about 2 years. The first two visits of the study will be completed within one month of each other (these are the baseline visits). The second two visits will be completed about two years later (these are the follow-up visits).

Participants will be compensated for their time and reimbursed for any parking or transportation expenses.

Primary Investigator:

Daniel Wolf, M.D., Ph.D.

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Neuroimaging of Executive Function (Cognition) in Youth

This research study focuses on how developing brain networks allow children to deploy executive function—which includes self-control.

Basic Inclusion Criteria:

  • Ages 8-15

Procedures:

  • Clinical assessment
  • Decision-making and puzzle-like games on a computer
  • Questionnaires about moods and feelings
  • 1-hour MRI scan

Duration:

3 times during a 5-year span. At each time point, there will be two different study visits. Each visit lasts approximately 3.5 hours.

Participants will be compensated for their time and travel.

Primary Investigator:

Theodore Satterthwaite, M.D., M.A.

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Risk and Resilience to Developmental Stress

This study aims to understand why some people are resilient when experiencing stressful life events as they grow up, while others are susceptible and develop distressing thoughts or emotions.

Basic Inclusion Criteria:

  • Ages 16-30

Procedures:

  • 1-hour interview answering questions about your thoughts and feelings
  • Puzzle-like games on a computer
  • Questionnaires about life history and personality traits
  • Blood sample
  • Saliva Sample
  • Stool Sample
  • Optional Small hair sample

Duration:

Approximately 4 hours

Participants will be compensated for their time and travel.

Primary Investigator:

Ran Barzilay M.D., Ph.D.

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1289-0032 Research Study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 52-week treatment period as an early intervention in patients with attenuated psychosis syndrome.

Additional Info:

This study tests whether BI 409306 prevents patients with a specific type of mental illness (attenuated psychosis syndrome) from becoming worse. This study looks at how well patients tolerate the medicine and how effective it is over 1 year.

For more info visit https://clinicalresearch.itmat.upenn.edu/clinicaltrial/5777/tbd-phase-ii- randomized-/

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Midline Measures of Psychosis

The purpose of this study is to improve our understanding and identification of individuals likely to develop idiopathic psychosis by studying the disruptions in olfactory, brain, and facial morphology in 22q11DS, particularly those with psychosis symptoms.

Inclusion Criteria:

  • Ages 8-30 years 

And fit one of the designated grouping categories:

  • DSM V schizophrenia or other psychotic disorder including schizoaffective disorder, delusional disorder, or psychotic disorder not otherwise specific (NOS), within 5 years of illness onset, defined as the earliest time point for which there is clear evidence of overt psychotic symptoms associated with deterioration in function
  • Clinical Risk status as evidenced by at least 1 positive or 2 negative/disorganized symptoms rate 3 or higher on the Scale of Prodromal Symptoms
  • Healthy subjects within the designated age range, not meeting inclusion criteria for any of the other groups
  • Confirmed 22q11 deletion syndrome

Procedures:

  • Facial structure (2D and 3D images)
  • Brain structure (MRI scan)
  • Olfactory (depth of olfactory sulcus, odor detection, odor identification, odor discrimination, odor detection threshold)

Duration:

One to 5 test sessions about 60-90 minutes

Primary Investigator:

David R. Roalf, Ph.D.

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7T GluCEST

The purpose of this study is to better understand short-term changes in brain neurochemistry in both normal development and early psychosis in order to improve our understanding and identification of adolescents and young adults at risk for developing psychosis.

Inclusion Criteria:

Ages 13-25 years

And fit one of the designated grouping categories:

  • DSM V Psychosis Spectrum disorder
  • Clinical Risk for psychosis as evidenced by at least 1 positive or 2 negative/disorganized symptoms rate 3 or higher on the Scale of Prodromal Symptoms
  • Healthy subjects within the designated age range, not meeting inclusion criteria for any of the other groups

Procedures:

  • Decision-making and puzzle-like games on a computer (60-75 minutes)
  • Questionnaires about moods and feelings (30-45 minutes)
  • MRI Scan (60-90 minutes)

Duration: 

2-3 test sessions during a 5-year span. 

Participants will be compensated for their time and reimbursed for any parking or transportation expenses.

Primary Investigator:

David R. Roalf, Ph.D.

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GluCEST_Age

Our goal is to examine development of neurochemistry in the aging process. By studying people of different ages, obtaining MRI scans, and using new computerized games, more can be learned about how the brain ages.

Inclusion Criteria:

  • Ages 18-30 or 60-85
  • No neurological or psychiatric diagnosis
  • No CNS-altering medication use
  • Able to complete an MRI

 

Procedures:

  • Screening questionnaire
  • Computerized games and surveys to assess memory, attention, and cognition
  • Neuroimaging – MRI

 

Duration:

Total study time will be about 3 to 5 hours, which can be completed in 1 or 2 visits. Participants will be compensated for their time.

 

Primary Investigator:

David R. Roalf, PhD

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Creating an Adaptive Screening Tool for Phenotyping Neurocognition and Psychopathology

The purpose of this study is to creating an adaptive screening tool for phenotyping neurocognition and psychopathology.

Basic Inclusion:
Age 18-35 years old.

Procedures:
Clinical Interview
Decision making and puzzle-like games on the computer
 

Duration:
Total of 3-4 total hours over 2-3 visits (virtual or in-person)

Primary Investigator
Ruben Gur, Ph.D.
Raquel Gur, M.D., Ph.D.

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