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NCT01903447 · ClinicalTrials.gov registry record · Phase 4
Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment
A Phase 4 study of Internalizing Psychopathologies (IPs) Depression and Anxiety, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 271
- Enrollment target
- 1
- Study location
NCT01903447 is a Phase 4 study of Internalizing Psychopathologies (IPs) Depression and Anxiety that has completed, run by University of Illinois at Chicago. The registered enrollment target is 271 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01903447, a Phase 4 study of Internalizing Psychopathologies (IPs) Depression and Anxiety, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 271 participants
- Enrollment target
- 1
- Study location
Study Summary
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 findin
Conditions Studied
Interventions
- BEHAVIORAL CBT
- DRUG SSRI
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2018-02-21 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903447
The ClinicalTrials.gov registry entry for NCT01903447 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Internalizing Psychopathologies (IPs) Depression and Anxiety appearing as the primary indexed condition, and to 2 interventions - of which CBT is the first listed.
NCT01903447 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01903447 about?
NCT01903447 is a clinical study titled "Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment". 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 ...
What is the current status of trial NCT01903447?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 271 participants. The study started on 2013-12-13. Estimated completion is 2018-02-21.
What conditions does trial NCT01903447 study?
This clinical trial studies the following conditions: Internalizing Psychopathologies (IPs) Depression and Anxiety.
What interventions are being tested in trial NCT01903447?
The interventions under investigation include: CBT (BEHAVIORAL), SSRI (DRUG).
Who is sponsoring clinical trial NCT01903447?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01903447 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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