Internalizing Psychopathologies (IPs) Depression and Anxiety Clinical Trial
Official title:
Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment
| Verified date | January 2018 |
| Source | University of Illinois at Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Internalizing psychopathologies (IPs) involving depression and anxiety are among the most
prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent to
which individual patients respond is quite heterogeneous. Little information exists,
particularly in the biological domain, which helps to explain individual differences in
treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic Affect
Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used, 'gold
standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive
behavioral therapies (CBTs) - are equally effective for both anxiety and depressive
disorders, and appear to change brain activity in the same areas within the FLARES circuit.
The overarching goal of the project is delineate what are common versus specific FLARE brain
targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might better
predict response to both and to a specific modality of treatment. This experiment integrates
emotion and its interaction with cognition across several stages of emotional experience,
encompassing studies that probe sensitivity to acute and potential threat and automatic and
volitional forms of affect regulation in relation to the FLARES brain network.
We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking
treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized
as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT.
Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES
function, will be measured before and after each treatment. Specifically, the project will
examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on
NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI
and CBT treatment? Such findings can be used to guide the right patients to the right
treatments with the highest likelihood of success. They also elucidate a
pathophysiologically-driven mechanistic model of where and how treatments work in the brain
and thus hasten the development of new treatments that target the underlying pathophysiology
across internalizing conditions.
| Status | Completed |
| Enrollment | 271 |
| Est. completion date | February 21, 2018 |
| Est. primary completion date | February 21, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Generally medically and neurologically healthy - Chief complaint(s) of "anxiety, worry, and/or depressed mood Exclusion Criteria: - Current or past manic/hypomanic episode or psychotic symptoms - Suicidal ideation - Presence of contraindications (e.g., history of SSRI adverse events) or prior history of SSRI resistance (no response to > 2 SSRI trials with adequate duration and dose) - Obsessive compulsive disorder (OCD) - Current cognitive dysfunction (traumatic brain injury, mental retardation, dementia) - Current alcohol and substance dependence - Ongoing therapy/medication treatment of any kind outside of this study |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Illinois at Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| University of Illinois at Chicago | National Institute of Mental Health (NIMH), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain NVS Construct Measure (Composite) | Brain: functional magnetic resonance imaging (fMRI) BOLD percent signal change [PSC] within region of interests [ROIs: amygdala, bed nucleus of stria terminalis, striatum, hippocampus, anterior cingulate cortex (including dorsal, rostral, & subgenual subdivisions), anterior insula, ventro/dorso-medial prefrontal cortex, orbitofrontal cortex, ventro/dorso-lateral prefrontal cortex for Emotional Face Assessment Task (EFAT), Emotional Face Interference Task (EFIT), Contextual Threat Task (CTT), Emotion Regulation Task (ERT) | Change from Week 0 to Week 12 |