ClinicalTrials.gg
CompletedNCT03260985PPCUpdated Feb 7, 2020

Precision Psychiatry Continuity Clinic Project

An interventional study of Feedback Report in Depressive Disorders, Depressive Symptoms and Anxiety Disorders and Symptoms, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 13 studies in Depressive Disorder by Stanford University — none open to participants now, none under way, none of them phase 3. Depressive Disorder · Stanford University.

Started
2017
with 1 other
No phase
6 of 13
none open now
Registered
11th of 13
by date

Among the 13 studies in Depressive Disorder by Stanford University, this one is one of 2 that started in 2017, is one of 6 with no phase, and was the 11th registered.

Depressive Disorder

855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.

Browse Depressive Disorder studies →

Open to participants now

None of the 13 studies in Depressive Disorder by Stanford University is open now. The open studies under Depressive Disorder, anywhere →

Where they have run

Who these studies take

Of the 116 Depressive Disorder studies recruiting now, 44 (38%) set no upper age limit and 66 (57%) stop at 75 or younger; 24 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 13 studies in Depressive Disorder by Stanford University as a file.
02

Study summary

This is a demonstration project focused on translating neuroscience insights into clinical practice. The researchers will evaluate how neuroscience assessments may be applied in the clinical setting to help inform care decisions. The aim of the study is to undertake a pragmatic pilot trial to assess whether the inclusion of structured feedback from neuroscience assessments has an effect on improving patient outcomes. The study will investigate how neuroscience assessments can be integrated into and improve clinical care. The impact of sharing information and conclusions from these assessments with psychiatric providers will be explored. Outcomes will include symptoms, social/occupational function and qualify of life.

03

Conditions studied

  • Depressive Disorders
  • Depressive Symptoms
  • Anxiety Disorders and Symptoms
  • Psychological Distress
  • Mood Disorders
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18+ years of age
  • Fluent and literate in English, and able to understand task instructions
  • fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)
  • Must be referred for treatment at the Stanford Department of Psychiatry Continuity Clinic

Exclusion criteria

Exclusion Criteria:

  • Presence of suicidal ideations representing imminent risk
  • General medical condition, disease or neurological disorder that interferes with the assessments
  • Traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
  • Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
  • Pregnancy
  • Presence of acute psychosis, schizophrenia spectrum, or other psychotic disorders
  • Concurrent participation in intervention or treatment studies
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Feedback Group

    All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. Participants randomized to the Feedback Group will have the results of this assessment shared with their psychiatric treatment team before they begin treatment. This data will be used at the full discretion of the treatment team to inform personalized treatment options. All treatment decisions remain up to the treatment providers and patient.

    Other: Feedback Report

  • No intervention
    Delayed Feedback Group

    All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. However, participants randomized to the Delayed Feedback Group will not have the results of this assessment shared with their treatment team until the end of their participation in this study (12 weeks).

Interventions

  • OtherFeedback Report

    A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.

06

What researchers measure

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care

    Time frame: 12 weeks

  2. Generalized Anxiety Disorder Questionnaire (GAD-7)

    A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care

    Time frame: 12 weeks

Secondary outcomes

  1. Sheehan Disability Scale (SDS) of Social/Occupational Functioning

    Level of functioning in social, occupational, and home life domains

    Time frame: 12 weeks

  2. Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)

    Burden of side effects from psychiatric medication

    Time frame: 12 weeks

07

Study locations

1 site
  • Stanford Center for Cognitive and Neurobiological Imaging (CNI)
    Stanford, California 94305, United States
08

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 Jul 2017 to primary completion in Dec 2019, 28 months.

Of 261 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's 28 months is close to that.

Counting every sponsor, half of 275 studies reached it within 29 months; a quarter within 15 and three quarters within 45.

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

Registered
Aug 22, 2017
First posted
Aug 24, 2017
StartActual
Jul 25, 2017
Primary completionActual
Dec 1, 2019
CompletionActual
Dec 1, 2019
Last update
Feb 7, 2020
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 Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03260985
Responsible party
Leanne Williams (Professor, Stanford University) — Principal investigator
First posted
Aug 24, 2017
Start date
Jul 25, 2017
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Feb 7, 2020

Study contacts

Leanne Williams, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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