Characterizing Clinical and Pharmacological Neuroimaging Biomarkers

NCT03842800 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1111009332
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of a larger overall study that seeks to characterize clinical and pharmacological neuroimaging biomarkers. The purpose of this registered protocol is understand the effect of emotion on cognitions by specifically examining the effect of reward processing on working memory in patients with schizophrenia.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Working Memory (WM)

  The tool used to measure working memory (WM) is a spatial working memory task. We measure angular accuracy of spatial working memory, and better accuracy is indicated by a lower angular distance. Subjects are asked to centrally fixate, and a circle appears on the screen briefly, and then disappears. Afterwards they see a gray circle that is linked to a joystick and are asked to move the gray circle to where they best remembered the initial circle to be. We care about the angular distance between where the initial circle appeared and where they placed the gray circle. The low range is 0 degrees, and the high range is 180 degrees. Scores are presented as averages and standard deviations.

  Up to 2 hours

Secondary Outcomes (3)

• Behavior

  Up to 2 hours

• BOLD

  Up to 2 hours

• Whole brain connectivity

  Up to 2 hours

Study Arms (4)

ASD Patients

OTHER

This arm consists of patients diagnosed with Autism Spectrum Disorder (ASD) that will receive an MRI.

Other: MRI

Schizophrenic Patients

OTHER

This arm consists of patients diagnosed with Schizophrenia that will receive an MRI.

Other: MRI

Healthy Controls

OTHER

This arm consists of healthy control volunteer participants that will receive an MRI.

Other: MRI

Healthy Controls with Ketamine

EXPERIMENTAL

This arm consists of healthy control volunteer participants that elect to receive ketamine prior to receiving an MRI.

Other: MRI; Drug: Ketamine

Interventions

MRI OTHER

Patients and volunteers will receive an MRI.

Also known as: Magnetic Resonance Imaging

ASD Patients; Healthy Controls; Healthy Controls with Ketamine; Schizophrenic Patients

Ketamine DRUG

Ketamine will be administered to a subset of healthy controls that agree to receive the drug as part of receiving an MRI.

Healthy Controls with Ketamine

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For BOTH Non-Healthy Controls and Healthy Controls:
• Right-handed as determined by the Edinburgh handedness questionnaire (Oldfield, 1971).
• Premorbid IQ\>70 determined by WAIS similarities and matrix reasoning subtests; Any history indicating learning disability, mental retardation, or attention deficit disorder will exclude the subject from participation.
• Must speak or read English at least 8th grade level or higher and to complete study evaluations.
• Must have intact vision or vision that can be corrected by glasses or contact lenses (corrected 20 20/20).
• Must be able to tolerate enclosed spaces \*\* only if participating in MRI portion.
• Female subjects must be postmenopausal for a least 1 year, surgically sterile, or using a reliable method of contraception at screening. Reliable methods of contraception include double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, or hormonal birth control methods. Women with positive serum pregnancy results at screening or self-reporting of pregnancy will be excluded from the study. \*\* only if participating in MRI portion.
• Must be free of metallic foreign objects in body, such as aneurysm clips or pacemakers, or a questionable history of metallic fragments \*\* only if participating in MRI portion.
• For Non-Healthy Controls Participants:
• Adult patients from the community meeting diagnostic criteria for schizophrenia, schizoaffective disorder, psychosis at risk syndrome, Major Depressive Disorder or autism spectrum disorders.
• Young adults (16-21) who are at risk of developing schizophrenia (have "prodromal schizophrenia") may be involved in the study.

You may not qualify if:

• For Healthy Controls:
• Evidence or history of serious medical or physical conditions, including severe endocrine disorder (Cushing's, Lupus), heart disorder (past history of heart attacks, angina), or other major systemic medical conditions (kidney, MS, CP, blindness, serious physical disability).
• Neurological conditions that might confound the results, including past stroke, seizures, dementia, brain tumor, brain surgery, neurological disease, head injury, or severe concussion (lasting \>2 minutes in their life).
• Individual not larger than 55" around shoulders and widest part of chest (approx. 250lb limit) \*\* only if participating in MRI portion.
• Any other condition that is contra-indicated for fMRI if selected to participate in fMRI portion as determined by the MRRC safety screen. \*\* only if participating in MRI portion.
• Meeting current diagnostic criteria for any DSM-IV Axis I psychiatric disorders, determined by SCID-NP / MINI interviews.
• First-degree relative with Axis I DSM-IV disorder.
• Regular use of psychoactive drugs including anxiolytics and antidepressants.
• Meeting current DSM-IV abuse and/or dependence diagnostic criteria for other substances, other than nicotine in the past 6 months as determined by SCID-NP / MINI interviews (excluding caffeine).
• For Non-Healthy Controls:
• Medical. Evidence or history of serious medical or physical conditions, including severe endocrine disorder (Cushing's, Lupus), heart disorder (past history of heart attacks, angina), or other major systemic medical conditions (kidney, MS, CP, blindness, serious physical disability).
• Neurological conditions that might confound the results, including past stroke, seizures, dementia, brain tumor, brain surgery, neurological disease, head injury, or severe concussion (lasting \>2 minutes in your lifetime).
• Individual not larger than 55" around shoulders and widest part of chest (approx. 250lb limit) \*\* only if participating in MRI portion.
• Any other condition that is contra-indicated for fMRI if selected to participate in fMRI portion as determined by the MRRC safety screen. \*\* only if participating in MRI portion.
• Meeting current diagnostic criteria for primary DSM-IV anxiety, depression or ADHD, determined by SCID-NP / MINI interview due to possible effects on cognition.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Magnetic Resonance Research Center

New Haven, Connecticut, 06520-8043, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy; Ketamine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alan Anticevic, PhD

  Yale University School of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 15, 2019
• Study Start: April 1, 2013
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

US (1)