ClinicalTrials.gg
CompletedNCT03310398RDoCUpdated Oct 16, 2017

Negative-Positive Valence Domains in Anxiety and Depression

An observational study in Anxiety and Depression, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-16.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, San Diego · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
248
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Depression by University of California, San Diego — 6 open to participants now, 10 under way, 1 of them phase 3. Depression · University of California, San Diego.

Started
2013
with 1 other
Observational
3 of 30
1 open now
Registered
10th of 30
by date

Among the 30 studies in Depression by University of California, San Diego, this one is one of 2 that started in 2013, is one of 3 observational ones, and was the 10th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

6 of the 30 studies in Depression by University of California, San Diego are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Depression by University of California, San Diego, or all of them as a file.
02

Study 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.

Read the detailed description

Participants presenting to the UCSD and UCLA primary care clinics will be screened as part of their routine visit using the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7 (GAD-7). Participants who call in will be asked to provide verbal informed consent for phone screening and the IRB approved Screening Questionnaire and the Overall Anxiety Severity and Impairment Scale (OASIS) will be administered.

Participants who remain eligible after the phone screening will be asked to return for a Clinical Interview, Behavioral Session, Biomarker blood draw, (and optional genetics), and Neuroimaging Session.

All participants will be contacted approximately 3-months later and invited to complete the same battery of self-report measures completed during the baseline session (described below). The self-report measures will be administered through a secure on-line survey database. This data will allow investigators to (1) confirm that participants continue to meet initial eligibility criteria and are therefore eligible for the full re-test battery and (2) use baseline measures of positive and negative valence domains to predict changes in symptoms and functioning.

A subset of 50 participants (n=25 from each UCSD and UCLA) will be randomly selected to return approximately three months later to complete the same battery of assessments in the Behavioral and Neuroimaging Sessions to establish test-retest reliability of the latent constructs.

03

Conditions studied

  • Anxiety
  • Depression

Browse trials for

04

In context

Depression Reclassified

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

This study's enrollment of 248 is above the median of 175 across 1,259 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

  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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
248 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • BehavioralNeuroImaging

    standard anatomical and functional imaging

  • BehavioralPsychophysiological

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

07

What researchers measure

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.

    Time frame: 4 years

08

Study locations

1 site
  • UCSD Psychiatry Clinical Research
    La Jolla, California 92093-0855, United States
09

References and documents

Publications

  • 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. PubMed 20595427 ↗
  • 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. PubMed 12813115 ↗
  • 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. PubMed 20483968 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2013 to primary completion in Apr 2017, 43 months.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's 43 months is above that.

Counting every sponsor, half of 493 studies reached it within 32 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2015
First posted
Oct 16, 2017
StartActual
Sep 1, 2013
Primary completionActual
Apr 30, 2017
CompletionActual
Jun 30, 2017
Last update
Oct 16, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03310398
Responsible party
Martin Paulus (Adjunct Professor of Psychiatry, University of California, San Diego) — Principal investigator
First posted
Oct 16, 2017
Start date
Sep 1, 2013
Primary completion
Apr 30, 2017
Completion
Jun 30, 2017
Last update
Oct 16, 2017

Study contacts

Martin P Paulus, MD
principal investigator · UC San Diego
Murray B Stein, MD, MPH
principal investigator · UC San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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