Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-13

Study Completion Date

2018-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Internalizing Psychopathologies (IPs) Depression and Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SSRI

sertraline: 100-200mg, citalopram 20-40mg, escitalopram 10-20mg, paroxetine 20-60mg; fluoxetine 20-80mg

Group Type ACTIVE_COMPARATOR

SSRI

Intervention Type DRUG

CBT

12 weeks of individual cognitive behavioral therapy

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

Interventions

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SSRI

Intervention Type DRUG

CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes