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

NCT02450240 | Completed

• 1 other identifier: 2014-002
• Study Type: observational
• Target: 1,271
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Eating Disorders; Drug Use Disorders

Keywords

Depression; Anxiety; Eating Disorders; Substance Use; Functional Magnetic Resonance Imaging; Genetics; Behavior; Mental Health

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Clinical Diagnosis

  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

  Baseline and 1 year

Study Arms (4)

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

Interventions

standardized diagnostic assessment BEHAVIORAL

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

self-report questionnaires BEHAVIORAL

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

behavioral tasks BEHAVIORAL

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

physiological measurements OTHER

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

structural and functional magnetic resonance imaging and EEG OTHER

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

biomarker and microbiome assessments OTHER

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

blood to derive induced pluripotent stem cells OTHER

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

genetic and epigenetic assessments OTHER

Depression and Anxiety Disorders; Eating Disorders; Healthy Controls; Substance Use Disorders

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• Referred or seeking treatment, as defined by answering yes to "have you sought help for problems with":
• Anxiety and/or depressive symptoms
• Problems related to substance use
• Problems related to eating behavior
• Screened positive for problems in (1) as indicated by:
• Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
• Drug Abuse Screening Test (DAST-10) score \> 2
• Eating Disorder Screen (SCOFF) score ≥ 2
• Have a body mass index between 17 to 38 kg/m²
• Able to provide written informed consent.
• Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

You may not qualify if:

• No telephone or easy access to telephone.
• 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.
• A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
• Has any of the following DSM-V disorders:
• Schizophrenia Spectrum and Other Psychotic Disorders
• Bipolar and Related Disorders
• Obsessive-Compulsive and Related Disorders
• Antisocial Personality Disorder
• Moderate to severe traumatic brain injury or other neurocognitive disorder
• Active suicidal ideation with intent or plan.
• Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
• Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
• Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \> 1000 mg/day)
• MRI contraindications
• Unwillingness or inability to complete any of the major aspects of the study protocol

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• University of Oklahoma: collaborator
• Rutgers University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (14)

• Sanislow CA, Pine DS, Quinn KJ, Kozak MJ, Garvey MA, Heinssen RK, Wang PS, Cuthbert BN. Developing constructs for psychopathology research: research domain criteria. J Abnorm Psychol. 2010 Nov;119(4):631-9. doi: 10.1037/a0020909.

  PMID: 20939653 BACKGROUND

• Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.

  PMID: 20595427 BACKGROUND

• Park H, Forthman KL, Kuplicki R, Victor TA, Yeh HW, Thompson WK, Howlett JR, Guinjoan S, Paulus MP. Polygenic risk for neuroticism is associated with less efficient control in more difficult situations. Psychiatry Res Neuroimaging. 2023 Oct;335:111716. doi: 10.1016/j.pscychresns.2023.111716. Epub 2023 Sep 14.

  PMID: 37717543 DERIVED

• Forthman KL, Kuplicki R, Yeh HW, Khalsa SS, Paulus MP, Guinjoan SM. Transdiagnostic behavioral and genetic contributors to repetitive negative thinking: A machine learning approach. J Psychiatr Res. 2023 Jun;162:207-213. doi: 10.1016/j.jpsychires.2023.05.039. Epub 2023 May 5.

  PMID: 37178517 DERIVED

• Sanchez SM, Tsuchiyagaito A, Kuplicki R, Park H, Postolski I, Rohan M, Paulus MP, Guinjoan SM. Repetitive Negative Thinking-Specific and -Nonspecific White Matter Tracts Engaged by Historical Psychosurgical Targets for Depression. Biol Psychiatry. 2023 Oct 15;94(8):661-671. doi: 10.1016/j.biopsych.2023.03.012. Epub 2023 Mar 23.

  PMID: 36965550 DERIVED

• Park H, Sanchez SM, Kuplicki R, Tsuchiyagaito A, Khalsa SS, Paulus MP, Guinjoan SM. Attenuated interoceptive processing in individuals with major depressive disorder and high repetitive negative thinking. J Psychiatr Res. 2022 Dec;156:237-244. doi: 10.1016/j.jpsychires.2022.10.020. Epub 2022 Oct 10.

  PMID: 36270063 DERIVED

• Kirlic N, Kuplicki R, Touthang J, Cohen ZP, Stewart JL; Tulsa 1000 Investigators; Paulus MP, Aupperle RL. Behavioral and neural responses during fear conditioning and extinction in a large transdiagnostic sample. Neuroimage Clin. 2022;35:103060. doi: 10.1016/j.nicl.2022.103060. Epub 2022 May 25.

  PMID: 35679785 DERIVED

• Park H, Kirlic N, Kuplicki R; Tulsa 1000 Investigators; Paulus M, Guinjoan S. Neural Processing Dysfunctions During Fear Learning but Not Reward-Related Processing Characterize Depressed Individuals With High Levels of Repetitive Negative Thinking. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jul;7(7):716-724. doi: 10.1016/j.bpsc.2022.01.002. Epub 2022 Jan 20.

  PMID: 35065290 DERIVED

• Burrows K, Stewart JL, Kuplicki R, Figueroa-Hall L, Spechler PA, Zheng H, Guinjoan SM; Tulsa 1000 Investigators; Savitz JB, Kent Teague T, Paulus MP. Elevated peripheral inflammation is associated with attenuated striatal reward anticipation in major depressive disorder. Brain Behav Immun. 2021 Mar;93:214-225. doi: 10.1016/j.bbi.2021.01.016. Epub 2021 Jan 26.

  PMID: 33508469 DERIVED

• White EJ, Kuplicki R, Stewart JL, Kirlic N, Yeh HW; T1000 Investigators; Paulus MP, Aupperle RL. Latent variables for region of interest activation during the monetary incentive delay task. Neuroimage. 2021 Apr 15;230:117796. doi: 10.1016/j.neuroimage.2021.117796. Epub 2021 Jan 24.

  PMID: 33503481 DERIVED

• Spechler PA, Stewart JL, Kuplicki R, Paulus MP; Tulsa 1000 Investigators. Parsing impulsivity in individuals with anxiety and depression who use Cannabis. Drug Alcohol Depend. 2020 Dec 1;217:108289. doi: 10.1016/j.drugalcdep.2020.108289. Epub 2020 Sep 16.

  PMID: 33002704 DERIVED

• Howlett JR, Thompson WK, Paulus MP. Computational Evidence for Underweighting of Current Error and Overestimation of Future Error in Anxious Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Apr;5(4):412-419. doi: 10.1016/j.bpsc.2019.12.011. Epub 2019 Dec 24.

  PMID: 32107167 DERIVED

• Howlett JR, Paulus MP. Where perception meets belief updating: Computational evidence for slower updating of visual expectations in anxious individuals. J Affect Disord. 2020 Apr 1;266:633-638. doi: 10.1016/j.jad.2020.02.012. Epub 2020 Feb 3.

  PMID: 32056939 DERIVED

• Victor TA, Khalsa SS, Simmons WK, Feinstein JS, Savitz J, Aupperle RL, Yeh HW, Bodurka J, Paulus MP. Tulsa 1000: a naturalistic study protocol for multilevel assessment and outcome prediction in a large psychiatric sample. BMJ Open. 2018 Jan 24;8(1):e016620. doi: 10.1136/bmjopen-2017-016620.

  PMID: 29371263 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Serum, Plasma, Microbiome

MeSH Terms

Conditions

Depression; Anxiety Disorders; Feeding and Eating Disorders; Substance-Related Disorders; Behavior; Psychological Well-Being

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Martin P Paulus, M.D.

  Laureate Institute for Brain Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 21, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)