UTSW Depression Cohort: A Longitudinal Study of Depression



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:10 - 89
Updated:6/3/2018
Start Date:February 2016
End Date:February 2027
Contact:Briana Gil, BA
Email:D2K@UTSouthwestern.edu
Phone:214 648 4357

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This is a longitudinal observational study (via electronic records and biospecimens) designed
to utilize health IT advances to collect information from patients undergoing routine care.
This information will be stored in a database. Patients undergoing routine care from their
providers will be invited to participate in the UTSW Depression Cohort. After obtaining
informed consent, the CDRCC team will collect information from available sources and store it
in a secure UT Southwestern network database protected by a security firewall. A schematic
representation of this information processing is shown in the figure contained in section 3
of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their
specimens. Specimens which are banked may include blood or blood products, urine, tissue
samples, saliva, stool samples or clinical waste products. The study will only enroll
participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort
is to create a national database, CDRCC will engage with patients, providers, and researchers
at local, regional, and national levels. A large number of medical providers are already
screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used.
Hence, the CDRCC will seek collaborations with local, regional and national partners so that
information contained in their health IT initiatives can be included in the this database.
Due to the clinical nature of information collected, the investigators anticipate marked
heterogeneity in the variables and amount of data collected. Database architects will utilize
big data (large volumes of information from diverse sources with variable degrees of quality
and complexity) tools to structure the registry so that additional variables can be added, as
needed. The CDRCC team will maintain a detailed codebook of variables collected in the
database. All statistical analyses will be conducted only on de-identified data. Researchers
may obtain access to this de-identified data by following procedures established by the
CDRCC, which include obtaining IRB approval.

This is a longitudinal observational study designed to utilize health IT advances to collect
information from patients undergoing routine care. This information will be collected as part
of routine care and stored in a database for research purposes. Patients undergoing routine
care from their providers will be invited to participate in the UTSW Depression Cohort. After
obtaining informed consent, the CDRCC team will collect information from sources outlined in
background section of protocol and store it in a secure UT Southwestern network database
protected by a security firewall. A schematic representation of this information processing
is shown on page 7 of the protocol. The CDRCC team will also collect specimens which are
obtained as part of standard of care and are beyond the amount needed for routine clinical
care. For research-only purposes, CDRCC team will also collect blood, saliva, stool and urine
specimens at regular intervals described in subsequent section with the consent of study
participant.

Clinics or health care facilities collaborating with CDRCC will approach their patients to
participate in this cohort. Research staff from UTSW or staff at these clinics (or health
care facilities) who have received training on how to obtain informed consent will then ask
interested patients to sign the IRB-approved Informed Consent and HIPAA authorization
documents. Initially, the Informed Consent and HIPAA authorization will be documented on
paper, and these documents will be scanned and stored in the master log of the Cohort
database in addition to securely storing the paper copy. In the future, patients will be
asked to complete Informed Consent and HIPAA authorization documents using computers or
handheld electronic devices (including signatures). Paper documents will be made available to
those who prefer and request them. Staff from CDRCC will be available either in person, by
email, or by phone to answer any questions that arise during the informed consent process
that cannot be answered by clinic staff. If patients are under the age of 18, they will
provide assent, and a parent or LAR will provide consent. The CDRCC will also develop
materials in print and electronic format to publicize the UTSW Depression Cohort. Other
patients or healthy individuals who are not involved with a CDRCC collaborator can also join
the registry if they complete the informed consent process. The UTSW Depression Cohort will
include comprehensive information collected as part of routine care by the patient's
provider(s). During routine care at their medical providers' offices, patients may fill out
screening questionnaires and self-rated behavioral health assessments, provide medical and
psychiatric history, undergo laboratory tests, electrocardiogram (EKG), radiologic or other
clinically relevant investigations and be given treatment recommendations. Some of the
self-rated assessments completed as part of measurement based care may include Patient Health
Questionnaire 2 (PHQ-2), Patient Health Questionnaire 9 (PHQ-9), Patient Adherence
Questionnaire (PAQ), Frequency, Intensity, and Burden of Side Effects Rating (FIBSER),
Generalized Anxiety Disorder 7 (GAD-7), Concise Associated Symptoms Tracking - Self-Report
Scale (CAST-SR), Pain Frequency, Intensity, and Burden Scale (P-FIBS), Concise Health Risk
Tracking Scale (CHRT), and Alcohol and Drug usage screen. The information in the Cohort
database will be stored indefinitely unless a participant requests the principal investigator
to remove his/her name and associated information.

Research only assessments As part of the UTSW Depression Cohort, participants will undergo
diagnostic assessment using MINI International Neuropsychiatric Interview, Version 7.0 for
DSM-5 (MINI) and complete self-report research assessments for psychiatric symptoms and
psychosocial functioning. These research only assessments will add 60-90 minutes to the visit
duration.

Specimen banking:

As part of the UTSW Depression Cohort, patients will allow banking of their specimens. The
study will only enroll participants comfortable with providing specimens. Of course, like
with any other study procedure, those not comfortable with providing specimens will not be
enrolled in this study. Specimens which are banked may include blood or blood products,
urine, stool samples, tissue samples, saliva or clinical waste products. Clinical waste
products include surgical waste tissue samples, placenta samples and biopsy samples. Once a
sample is collected, all identifying information will be removed, and it will be given a
unique code. The information linking this unique code to a patient's identifying information
will be stored in the master log. Samples will be stored appropriately in the CDRCC freezers
located in the north campus building of UT Southwestern. Samples will be overseen by CDRCC
research personnel. A sample will be stored indefinitely until the sample runs out or it is
destroyed.

Blood and blood products- Blood will be obtained by venipuncture performed by personnel with
phlebotomy training.

Adult blood draws will not exceed the following:

Patient weight Maximum Volume per 24 hour Maximum Volume per Month Kilograms Pounds
Milliliters Milliliters 51-60 112-132 112-120 224-240 61-65 134-143 122-130 244-260 68-70
145-154 132-140 264-280 71-75 156-185 142-150 284-300 76-80 167-176 152-160 304-360 81-85
178-187 162-170 324-340 86-90 189-198 172-180 344-360 91-95 200-209 182-190 364-380 96-100
211-220 192-200 384-400

Pediatric blood draws will not exceed:

Patient weight Maximum Volume per 24 hour Maximum Volume per Month Kilograms Pounds
Milliliters Milliliters <0.9 <2 3 12 0.9-1.8 2-4 4.5 18 1.9-2.7 4-6 6 24 2.8-3.6 6-8 7.5 30
3.7-4.5 8-10 10.5 42 4.6-6.8 10-15 15 60 6.9-9.1 16-20 30 120 9.2-11.4 21-25 30 120 11.5-13.6
26-30 30 120 13.7-15.9 31-35 30 120 16.0-18.2 36-40 30 120 18.3-20.5 41-45 60 240 20.6-22.7
46-50 60 240 22.8-25.0 51-55 60 240 25.1-27.3 56-60 60 240 27.4-29.5 61-65 75 300 29.6-31.8
66-70 90 360 31.9-34.1 71-75 90 360 34.2-36.4 76-80 90 360 36.5-38.6 81-85 90 360 38.7-40.9
86-90 90 360 41.0-43.2 91-95 90 360 43.3-45.5 96-100 90 360

Blood may be obtained as a single blood draw, which may be a patient's only collection.
Patients may be contacted to provide similar specimens at intervals around every 3-4 months
for over 5-10 years (for a total of 40 blood draws). Collections will be restricted by the
maximum safe volumes outlined above for both adult and pediatric participants. If being
obtained in a clinical setting, clinical care specimens will take precedence over research
specimens. If specimens are obtained during the course of clinical care, a safe volume will
be determined in conjunction with treating physicians, but will not exceed the above table.

Saliva- Saliva will be collected into the Oragene DNA and/or RNA self-collection kit and
stored at room temperature until DNA isolation.

Urine- Urine samples will be collected in sterile urinalysis cups and 10 mL aliquots will be
frozen at -80°C in conical tubes.

Stool- Stool samples will be collected once or possibly over time in conjunction with blood
draws described above in sterile 50 ml conical tubes and will be frozen at -80°C.

Clinical waste products- Samples obtained could include: a. surgical waste tissue samples; b.
placenta samples; and c. biopsy samples. These samples will be obtained as a part of standard
of care. Procedures involving these sample collections will be done by trained physicians and
medical technicians only. The tissue that will be used for research is the tissue that would
normally be discarded. After providing informed consent, study participants may allow study
personnel to collect these clinical waste products from the clinical sites. The clinical
waste product will then be transported to CDRCC on ice for storage. These samples will be
de-identified, stored and used for future research. There will be no cost or compensation to
the patients for donating this tissue to CDRCC.

The intended use of these samples is to enable future research into the diagnostics,
prognostics and biologic understanding of depression. The samples will be primarily used by
investigators affiliated with UT Southwestern, but will also be released to public and
private collaborators in a HIPAA compliant fashion (i.e., de-identified). Development of cell
lines and DNA libraries may occur with these samples. Samples may be used by investigators
not affiliated with UT Southwestern if they are collaborating with a UTSW investigator. Also,
samples may be used by colleagues at other institutions who are conducting their own IRB
-approved research. Furthermore, de-identified samples can be provided to collaborators in
industry if appropriate technology transfer agreements are in place. Samples sent to
investigators or private entities outside of UT Southwestern will have a charge associated
with them based on sample cost and projected use of the samples. Any specimen or data can be
released to collaborators (outlined above) as long as it is released in a HIPAA compliant
fashion (i.e., de-identified).

The investigators will obtain an IRB approval letter and maintain a current record of the
Federal Wide Assurance (FWA) for an IRB at another medical center if data and specimens are
sent from human cell banks at UT Southwestern to another medical center. If an investigator
at another medical center receives data and specimens from our Cohort at UT Southwestern, the
investigator will maintain documentation that (a) the recipient of samples from CDRCC
acknowledges that the conditions for use of the research material are governed by the IRB at
UT Southwestern in accordance with 45 CFR 46, (b) the recipient agrees to comply fully with
all such conditions and to report promptly to the CDRCC at UT Southwestern any proposed
changes in the research project, (c) the recipient remains subject to applicable State or
local laws or regulations and institutional policies which provide additional protections for
human subjects, and (d) the research material may be utilized only in accordance with the
conditions stipulated by the IRB at UT Southwestern. Any additional use of this material
requires prior review and approval by the IRB at UT Southwestern and, where appropriate, by
an IRB at the recipient site, which must be convened under an applicable OHRP-approved
Assurance. Non-UT Southwestern recipients of samples will be charged a usual and customary
fee for the sample to cover procurement costs.

Under the supervision of the principal investigator of CDRCC, two different subcommittees
will oversee the different aspects of the UTSW Depression Cohort: data management committee
and executive committee. The data management committee will be tasked with managing the flow
of information into and out of the Cohort database, maintaining the codebook of variables,
developing big data tools (as mentioned in specific aim 3), and ensuring consistency of data
collection and quality. The executive committee will be tasked with all other
responsibilities related to the registry like establishing collaborations with providers,
reviewing research proposals, and providing access to the cohort data for qualified
researchers.

All procedures will be conducted as part of a patient's routine medical care except for
collection of research-only blood, urine, and saliva specimens as described above. This study
does not involve any interventions.

Inclusion Criteria:

- Participants ages 10 - 89 years who speak English or Spanish (consent and HIPAA
authorization forms will be translated in Spanish for mono-lingual Spanish-speaking
only participants).

- Provide informed consent (parent or LAR for participants aged 10 to 17).

Exclusion Criteria:

- Participants who do not speak English or Spanish.

- Participants who are less than 10 or greater than 89 years old.
We found this trial at
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-4357
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