Negative-Positive Valence Domains in Anxiety and Depression

NCT03310398 | Completed

• 1 other identifier: 130554
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety and depression are highly prevalent and disabling conditions that frequently co-occur, and are costly to the individual and society. Despite important advances in our understanding of these disorders, there is a significant unmet need to identify reliable and clinically useful tests that can predict prognosis, inform treatment choice for a given individual, and improve treatment outcomes. The aim of this project is to fill this critical gap by validating a battery of measures including brain imaging, psychophysiology, behavior, and self-report that will reliably assess positive and negative affect, or valence, system functioning in a broad sample of individuals screened for anxiety and depression as part of their routine primary care visits.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Relationship of latent constructs of positive and negative valence domains and neural indices of reward sensitivity and fear conditioning in treatment seeking depressed and anxious individuals.

  Measure of BOLD % signal difference in brain regions of interest during reward or loss trials for anticipation and outcome phases in a reward paradigm, and conditioning trials in a fear conditioning paradigm.

  4 years

Study Arms (2)

Anxiety

elevated anxiety (as indicated by a GAD-7 score of 8 or higher)

Behavioral: NeuroImaging; Behavioral: Psychophysiological

Depression

elevated anxiety (as indicated by a GAD-7 score of 8 or higher)

Behavioral: NeuroImaging; Behavioral: Psychophysiological

Interventions

NeuroImaging BEHAVIORAL

standard anatomical and functional imaging

Anxiety; Depression

Psychophysiological BEHAVIORAL

Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram

Anxiety; Depression

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Investigators opted to identify individuals with anxiety or depression in a primary care setting, which investigators have used successfully to recruit a significant number of subjects, to maximize generalizability and external validity.

1. Positive for anxiety and/or depressive symptoms. 2. Score on the PHQ-9 and OASIS. 3. Between the ages of 18-55, inclusive. 4. Have signed informed consent document(s) indicating that participant understands the purpose of and procedures required for the study and willing to participate in the study. 5. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures. 6. Have telephone or easy access to telephone. 7. History of brain injury with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider). 8. Current and regular use of a medication that could affect brain functioning. 9. Must not have MRI contraindications such as: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy. 10. Intact or correctable vision and hearing.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

UCSD Psychiatry Clinical Research

La Jolla, California, 92093-0855, United States

Location

Related Publications (3)

• 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

• Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.

  PMID: 12813115 BACKGROUND

• Roy-Byrne P, Craske MG, Sullivan G, Rose RD, Edlund MJ, Lang AJ, Bystritsky A, Welch SS, Chavira DA, Golinelli D, Campbell-Sills L, Sherbourne CD, Stein MB. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. JAMA. 2010 May 19;303(19):1921-8. doi: 10.1001/jama.2010.608.

  PMID: 20483968 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood biomarkers: Investigators will assess blood biomarkers including norepinephrine, dopamine, epinephrine, creatinine, soluble cellular adhesion molecules (sICAM, sVCAM), IFN+ (IFN-gamma, IL-6, and TNF-alpha assayed together), and brain-derived neurotrophic factor (BDNF). Genetics: Furthermore, as noted later in this section of the application, investigators have identified abnormalities in functioning of key structures (e.g., amygdala and insula) within the brain's anxiety circuitry in anxiety-prone subjects and there is evidence that certain genes (e.g., SLC6A4) influence the extent of activation in these regions. The focus of this project is to determine to what extent variation in CRF system genes (i.e., CRF, CRF-R1, CRF-R2, UCN, UCN2, UCN3) is associated with anxiety disorders.

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Martin P Paulus, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

• Murray B Stein, MD, MPH

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Psychiatry

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 16, 2017
• Study Start: September 1, 2013
• Primary Completion: April 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

US (1)