Rescuing the Ruminating Brain: Identifying Biomarkers of Rumination and Mindfulness Through Concurrent EEG and Functional Magnetic Resonance Imaging (fMRI) Studies of Schizophrenia and Depression

NCT03758495 | Withdrawn

• 2 other identifiers: MHBB-012-17SCX000497
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will acquire simultaneous EEG and fMRI data from Veterans with depression and schizophrenia and mentally healthy Veterans to assess early sensory responses, context updating, and responses to emotional images. Understanding how rumination affects engagement with the environment is the first step towards assessing its far-reaching cognitive and emotional costs, which cut across traditional diagnostic boundaries. Understanding how mindfulness restores information processing will increase our understanding of how, and for whom, it works.

Conditions

Schizophrenia; Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• Electroencephalography (EEG)

  Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.

  Day 1

• Magnetic Resonance Imaging (MRI)

  Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.

  Day 1

• Memory and Attention task

  Listening to audio instructions.

  Day 1

Study Arms (3)

Patients with Schizophrenia

Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime.

Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Patients with Major Depressive Disorder

Individuals who have been previously diagnosed with major depressive disorder and meet our research criteria for symptoms indicative of major depressive disorder within their lifetime.

Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Healthy Controls

Individuals who have not met criteria for a psychiatric disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric disorder.

Other: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)

Interventions

Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) OTHER

The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, and healthy controls.

Healthy Controls; Patients with Major Depressive Disorder; Patients with Schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with schizophrenia and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study. Patients who have been diagnosed with major depressive disorder and meet our research criteria of symptoms indicative of a diagnosis of major depressive disorder within their lifetime are eligible for this study. Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.

You may qualify if:

• (All)
• Veterans
• years of age
• Negative metal screen for MR scanning
• Corrected to normal vision
• Meet criteria for SZ or MDD as assessed using the Structured Clinical Interview for DSM (SCID), with a consensus diagnosis between trained research staff member and an attending psychiatrist or psychologist.
• Stable medication regime for \> 1 month

You may not qualify if:

• (All)
• Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive sequelae)
• Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic sequelae
• Major medical conditions (e.g., significant hypertension, diabetes not controlled by diet alone, seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
• Substance abuse within three months of participation or any history of substance dependence
• History of HIV risk behaviors
• Known claustrophobia
• Pregnancy. If the participant cannot rule out pregnancy, a pregnancy urine test will be conducted moments before scanning.
• Uncorrected vision as assessed by the Snellen chart.
• \- Any primary Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Axis I diagnosis other than SZ or MDD
• Any past or present DSM Axis I diagnosis
• Chronic treatment with medication that affects cognitive function

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Judith M Ford, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 29, 2018
• Study Start: November 1, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)