Dallas 2K: A Natural History Study of Depression



Status:Recruiting
Conditions:Depression, Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:10 - Any
Updated:4/17/2018
Start Date:September 2016
End Date:September 2026
Contact:Briana Gil, BA
Email:D2K@UTSouthwestern.edu
Phone:214 648 4357

Use our guide to learn which trials are right for you!

The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of
2,000 participants that will help uncover the socio-demographic, lifestyle, clinical,
psychological and neurobiological factors that contribute to anti-depressant treatment
response: remission, recurrence, relapse and individual outcomes in depressive disorders.
Hence, the expected duration of this study is 20 years in length. Since this is an
observational study, investigators will explore a comprehensive panel of carefully selected
participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle
(physical activity, substance use); clinical (medical history, anxious depression, early life
trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive, emotional),
neurophysiological (EEG), and neuroimaging (structural, functional brain circuitry) with the
goal to develop the most robust predictive models of treatment response and of depression
outcomes. There is no medication or non-medication treatment or intervention provided by this
study.

Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive
disorder and will be currently receiving or will be prescribed standard of care medication or
non-medication based treatments by their providers/clinicians. The study cohort will reflect
the wide range of patients seen in typical primary or psychiatric care settings, and may
include unipolar or bipolar disorders and dysthymia (a more chronic form of depression). The
cohort will be broadly representative of and generalizable to the US general population as a
whole.

This is a non-randomized, natural history, non-treatment, longitudinal cohort study.
Participants will be receiving standard of care treatment for depression and other
comorbidities from their treating clinician and will be allowed to continue such treatments
in this study. There are no experimental study procedures, other than methods used for data
capture (questionnaires, blood collection, EEG and MRI). Participants will be expected to
visit study site (s) for repeated collection of data (assessments, biospecimens, and imaging
procedures), up to 4 times a year for 10 years. A reduced battery of tests is allowable if
subject is not able or willing to complete the full battery after the baseline visit.

2000 research participants will be enrolled and followed over an eight-year period (each
participant will be followed for 10-years) with collection of clinical and depression
measurement assessments, measurement of vital signs, collection of biospecimens for
biochemical and genetic analyses, electroencephalogram (EEG) with behavioral assessments, and
neuroimaging using magnetic resonance imaging (MRI). Skin punch biopsy will be performed in a
sub-set of the research cohort, defined as demonstrating a heritable phenotype of depression.
Stool sample will be performed in a sub-set of the research cohort, defined as demonstrating
a heritable phenotype of depression.

Participants will complete PHQ-9 (Patient Health Questionnaire-9), a brief self-administered
measure of depression severity, and PS (Psychosis Screening) questionnaire, as part of
inclusion and exclusion criteria, respectively. Participants will then complete all required
computer-assisted self-rating and clinician-administered instruments. The self-rating
instruments are expected to take approximately 2.5 hours using an iPad or laptop computer,
and will collect detailed socio-demographic, life habits, family and medical history, and
depression severity and treatment history. After completing the questionnaires, the research
personnel will measure the subject's blood pressure, height, waist and hip circumference and
weight. The subject will then provide blood, saliva and urine samples (morning blood draw
appointments will be offered whenever participants agree to fast before blood draws but
non-fasting blood will also be collected, when not possible to obtain fasting blood).

For study assessments, specimen collection; and EEG and behavioral phenotyping, Dallas 2K
study participants will require a 6-hour study visit to UT Southwestern. Participants will be
given the option to split their visit into two if that is more convenient, and visit 2 will
be used to perform EEG and behavioral assessments. Participants choosing the initial visit at
an MDN clinician's office will complete screening, assessments and biospecimen collection at
the MDN office but may require a 3-hour visit to UT Southwestern clinics for EEG and
behavioral assessments. The MRI may be performed during a separate 2-hour visit to UT
Southwestern MRI facility.

Schedule of study visits, procedures and duration:

Study A - Assessments and Questionnaires, 3 hours; Study B - EEG and Behavioral Phenotyping,
3 hours; Study C - Neuroimaging (MRI), 2 hours; Study D - Sub-Study only: Skin punch biopsy,
30 minutes; Study E - Sub-Study only: Stool Sample, 15 minutes; Study F - Sub-Study only:
mHealth, Continuous monitoring via a wristband (i.e. fitbit) and/or mhealth application
downloaded on a Android operating smartphone.

Studies A and B can be combined into a single 6-hour visit when occurring at UT Southwestern.

EEG and behavioral phenotyping and Neuroimaging will be performed at 3-month intervals.

For participants in the optional sub-study, skin punch biopsy, Study D will be performed
during any one of the other visits, depending on participants' convenience.

For participants in the optional sub-study stool sample, study E will be performed up to 4
visits per year for 10-years.

For participants in the optional sub-study mhealth study, Study F will be a continuous
monitoring of your physical activity, sleep patterns etc. via a wristband (i.e. Fitbit)
and/or mHealth application downloaded onto an Android operating Smartphone.

Study A will then be repeated at 3-month intervals for up to 4 times a year, during follow-up
study visits.

Phlebotomy Procedures Blood samples will be collected from participants by trained
phlebotomists, who will draw the sample using standard venipuncture procedures, through a
single venipuncture using a small gauge needle. Universal precautions will be observed by the
phlebotomists during all draws. The sample collection tubes, priority and volume collected
are indicated in the protocol. Each tube will be labeled and packaged for processing and
storage.

Electrophysiology (EEG) Procedures: Participants will undergo electrophysiology measures at
baseline and at 3-month intervals. Procedures for each of these measures are outlined below.
Detailed EEG procedures will be described in the EEG and Behavioral Tasks Procedures Manual,
respectively. The EEG markers in this study can be divided into three groups. Participants
will first undergo resting EEG. Resting EEG is measured during four, 2 minute periods, half
the time with the participants' eyes open, and the other half with the participants' eyes
closed. The second EEG measure will specifically localize theta activity using a technique
called Low Resolution Electromagnetic Tomography (LORETA). Finally, participants will have
head-phones placed, and will be presented with 1000 Hz tones at 5 different intensity levels.
The loudness dependency of auditory evoked potential (LDAEP) will be measured during this
time. The total time estimate for completion of the EEG collection at each visit is
approximately 2 hours. The EEG workgroup will ensure that adequate training, standardization
of measures, and validation of equipment is maintained for data consistencies and quality
control purposes.

Behavioral Phenotyping: The investigators will administer five distinct tasks to
participants, to assess four domains: 1) psychomotor slowing, 2) cognitive control, 3)
working memory, and 4) reward responsiveness. To assess these domains, the investigators plan
to administer the following tasks: psychomotor slowing, Choice RT task (~5 min) and word
fluency task (~5 min); cognitive control, the Flanker task (~10 min); working memory, the A
not B task (~10 min); and reward responsiveness, the Probabilistic Reward task (~10 min).
This task measures the subject's ability to modify behavior in response to rewards. On each
trial, the subject sees a cartoon face with a short or long mouth. The task is to indicate
whether a short or long mouth was presented by pressing one of two buttons. Critically, the
size difference between the short and long mouths is very small, and correct responses of one
type (e.g., short mouth) are followed by monetary rewards three times more frequently than
correct responses of the other type (e.g., long mouth). The primary dependent measure is
response bias: the degree to which the subject preferentially chooses the response that is
more frequently rewarded (in this example, short mouth vs. long mouth). Other dependent
measures include RT and a measure of the subject's ability to discriminate between the mouth
sizes (28). All tasks will be presented using Eprime software, under standardized procedures
across sites. The Behavioral Phenotyping workgroup will ensure that quality control is
maintained and that adequate training and standardization of measures is obtained prior to
study related activities commencing. The total time the investigators estimate for completion
of behavioral tasks at each study visit is about 1 hour.

Neuroimaging: Eligible participants will undergo neuroimaging at baseline and at 3-month
intervals. Neuroimaging includes both functional MRI and structural acquisitions. A brief
description of procedures for each of these is outlined below; detailed descriptions will be
in the Neuroimaging Procedures Manual. In total, the investigators estimate that
approximately 90 minutes will be spent in the scanner per visit. In addition, research
personnel will spend about 30 minutes preparing participants. Neuroimaging will be performed
at baseline (study entry) and at 3-month intervals, for a total of 10 total neuroimaging
sessions for the study duration.

The collection of socio-demographics, lifestyle, clinical and other health-related
information obtained through self-report questionnaires and clinician interviews will
complement the physical, biological, EEG and neuroimaging measurements collected at study
visits. The information obtained will form a database that allows a wide range of research
questions, both anticipated and unforeseen, to be addressed in the future.

Some questionnaires will be given to participant parents as required for minors. Additional
assessments completed with minors will be done with study staff to assist with any questions
or difficulty with the assessments.

Criteria for Inclusion of participants:

A potential participant will be eligible for participation in this study if the following
criteria are met:

1. Male and female adult or youth aged 10 and older of any race or ethnicity.

2. Ability to speak, read, and understand English. However, the parent(s) or legal
guardians of minors may either speak English or Spanish as the consenting process can
be conducted bilingually.

3. A lifetime or a current diagnosis of a mood disorder based upon a semi-structured
diagnostic interview.

4. Adults age 18 and older must be able to provide written informed consent; for youth
younger than age 18, a parent or legal guardian must provide written informed consent,
and the child or teen must provide written informed assent.

Eligibility for Healthy Controls

For comparison purposes, potential health control participants who do NOT have a
psychiatric diagnosis will be enrolled as part of the healthy control arm of this study.

1. Male and female adult or youth aged 10 and older of any race or ethnicity.

2. Ability to speak, read, and understand English. However, the parent(s) or legal
guardians of minors may either speak English or Spanish as the consenting process can
be conducted bilingually.

3. Adults age 18 and older must be able to provide written informed consent; for youth
younger than age 18, a parent or legal guardian must provide written informed consent,
and the child or teen must provide written informed assent.

Criteria for Exclusion of Participants

A potential participant will NOT be eligible for participation in this study if any of the
following criteria are met:

1. History of schizophrenia, schizoaffective disorders or chronic psychotic disorders
based upon a semi-structured diagnostic interview.

2. Diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C (human
immunodeficiency virus (HIV) testing is not required for this study).

3. Unable to provide a stable home address and contact information.

4. Has any condition for which, in the opinion of the investigator or designee, study
participation would not be in their best interest (including but not limited to
cognitive impairment, unstable general medical condition, intoxication, active
psychosis) or that could prevent, limit, or confound the protocol-specified
assessments.

5. Requires immediate hospitalization for psychiatric disorder or suicidal risk as
assessed by a licensed study clinician.

Eligibility for Healthy Controls

A potential Healthy Control participant will NOT be eligible for participation in this
study if any of the following criteria are met:

1. A lifetime or a current history of a mood disorder based upon a semi-structured
diagnostic interview.

2. Meets any exclusion criteria as part of the main D2K study interview.
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Madhukar Trivedi, MD
Phone: 214-648-4357
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials