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Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders

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ClinicalTrials.gov Identifier: NCT02450240
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
University of Oklahoma
Rutgers University
University of California, San Diego
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief Summary:
In this study the investigators will seek to improve our understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals and use a wide range of assessment tools, neuroimaging measures, blood and microbiome collections and behavioral tasks to complete the baseline and follow-up study visits. Upon completion, the investigators aim to have robust and reliable dimensional measures that quantify these systems and a set of assessments that should be recommended as a clinical tool to enhance outcome prediction for the clinician and assist in determining who will likely benefit from what type of intervention.

Condition or disease Intervention/treatment
Depression Anxiety Eating Disorders Drug Use Disorders Behavioral: standardized diagnostic assessment Behavioral: self-report questionnaires Behavioral: behavioral tasks Other: physiological measurements Other: structural and functional magnetic resonance imaging and EEG Other: biomarker and microbiome assessments Other: blood to derive induced pluripotent stem cells Other: genetic and epigenetic assessments

Detailed Description:

Neuroscience has made tremendous progress in understanding the basic neural circuitry that underlies important processes such as attention, memory, and basic emotion processing. Yet, little progress has been made to utilize these insights to apply them to psychiatric populations in order to make clinically meaningful predictions. The connection between psychiatric disorders and their underlying neurobiology has been difficult to establish. The overarching theme of this study is to determine how biological and objective behavioral measures can contribute to improving assessment and treatment of psychiatric patients. The investigators will use the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) framework as a heuristic approach that integrates neuroscience and psychopathology to study the positive and negative valence systems, cognition and arousal/interoception domains. Within this framework we will study a group of treatment seeking individuals with mental health conditions to determine how dysfunctions of affect, substance use, and eating behavior organize across different levels and whether these latent factors can be used to generate clinically useful prediction.

Using self-report, behavior, physiology, neural circuit, cell, molecule, and gene unit of analysis measures, the investigators propose to enroll 1000 individuals from four different cohorts over 5 years: (1) anxiety and/or depression; (2) eating problems; (3) substance use problems; and (4) healthy controls. Each individual will undergo a multi-level assessment that consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires, (c) behavioral tasks, (d) physiological measurements, (e) structural and functional magnetic resonance imaging (fMRI) and EEG, (f) biomarker and microbiome assessments, (g) blood to derive induced pluripotent stem cells, (h) and genetic and epigenetic assessments. These individuals will be followed up for one year and will be re-assessed using a multi-domain assessment of functioning, which will include: (a) symptom severity and duration, (b) subjective well-being, (c) psychosocial function, (c) occupational function, (d) physical health, (e) utilization of mental health resources (treatment), and (f) compliance with treatment.

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Study Type : Observational
Actual Enrollment : 1271 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: T-1000: Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Depression and Anxiety Disorders

350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.

Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments.

Behavioral: standardized diagnostic assessment
Behavioral: self-report questionnaires
Behavioral: behavioral tasks
Other: physiological measurements
Other: structural and functional magnetic resonance imaging and EEG
Other: biomarker and microbiome assessments
Other: blood to derive induced pluripotent stem cells
Other: genetic and epigenetic assessments
Eating Disorders

350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2.

Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments.

Behavioral: standardized diagnostic assessment
Behavioral: self-report questionnaires
Behavioral: behavioral tasks
Other: physiological measurements
Other: structural and functional magnetic resonance imaging and EEG
Other: biomarker and microbiome assessments
Other: blood to derive induced pluripotent stem cells
Other: genetic and epigenetic assessments
Substance Use Disorders

350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score > 2.

Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments.

Behavioral: standardized diagnostic assessment
Behavioral: self-report questionnaires
Behavioral: behavioral tasks
Other: physiological measurements
Other: structural and functional magnetic resonance imaging and EEG
Other: biomarker and microbiome assessments
Other: blood to derive induced pluripotent stem cells
Other: genetic and epigenetic assessments
Healthy Controls

150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use.

Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments.

Behavioral: standardized diagnostic assessment
Behavioral: self-report questionnaires
Behavioral: behavioral tasks
Other: physiological measurements
Other: structural and functional magnetic resonance imaging and EEG
Other: biomarker and microbiome assessments
Other: blood to derive induced pluripotent stem cells
Other: genetic and epigenetic assessments



Primary Outcome Measures :
  1. Change from Baseline in Clinical Diagnosis [ Time Frame: Baseline and 1 year ]
    Test the predictive effects of endophenotypes (genetic, imaging and behavioral factors) on clinical diagnosis at baseline compared to one year later using the Mini International Psychiatric Interview in patients and healthy controls


Biospecimen Retention:   Samples With DNA
Whole Blood, Serum, Plasma, Microbiome


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

  1. Referred or seeking treatment, as defined by answering yes to "have you sought help for problems with":

    1. Anxiety and/or depressive symptoms
    2. Problems related to substance use
    3. Problems related to eating behavior
  2. Screened positive for problems in (1) as indicated by:

    1. Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
    2. Drug Abuse Screening Test (DAST-10) score > 2
    3. Eating Disorder Screen (SCOFF) score ≥ 2
  3. Have a body mass index between 17 to 38 kg/m²
  4. Able to provide written informed consent.
  5. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion Criteria:

  1. No telephone or easy access to telephone.
  2. Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  3. A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
  4. Has any of the following DSM-V disorders:

    1. Schizophrenia Spectrum and Other Psychotic Disorders
    2. Bipolar and Related Disorders
    3. Obsessive-Compulsive and Related Disorders
    4. Antisocial Personality Disorder
  5. Moderate to severe traumatic brain injury or other neurocognitive disorder
  6. Active suicidal ideation with intent or plan.
  7. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
  8. Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
  9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
  10. MRI contraindications
  11. Unwillingness or inability to complete any of the major aspects of the study protocol
  12. Non-correctable vision or hearing problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450240


Locations
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United States, Oklahoma
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
University of Oklahoma
Rutgers University
University of California, San Diego
Investigators
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Study Director: Martin P Paulus, M.D. Laureate Institute for Brain Research
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02450240    
Other Study ID Numbers: 2014-002
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Laureate Institute for Brain Research, Inc.:
Depression
Anxiety
Eating Disorders
Substance Use
Functional Magnetic Resonance Imaging
Genetics
Behavior
Mental Health
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Depression
Feeding and Eating Disorders
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Chemically-Induced Disorders