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

Completed

Conditions studied: Depression, Anxiety, Eating Disorders, Drug Use Disorders

In brief

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.

Key facts

Study ID

NCT02450240

Run by

Laureate Institute for Brain Research, Inc.

People needed

1271

Starts

2015-01-01

Expected to finish

2020-06-01

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• Non-correctable vision or hearing problems

Where it is running

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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