CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01027559
NCT01027559N/ACompleted

fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes

Washington University School of Medicine·interventional·Posted Dec 8, 2009·Updated Jul 17, 2018

In Brief

A clinical study evaluating Sertraline and Cognitive Behavioral Therapy for Major Depression and Treatment. Completed, enrolled 97 participants across 1 site.

Detailed Summary

The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, and in comparison to healthy controls with no history of depression, to find out more about the causes of depression including differences in the extent of problems caused by depression. We hypothesize that CBT will have the same healing effect on the brain as antidepressants; that differences in brain activations created by the various tasks and genetic differences will help us understand differences in the type and severity of symptoms among the depressed subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.6 years ago

Interventions

Sertralinedrug

Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.

Cognitive Behavioral Therapybehavioral

Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.