Functional MRI Before and After Treatment for Depression
|ClinicalTrials.gov Identifier: NCT00896441|
Recruitment Status : Terminated (Funding ended)
First Posted : May 11, 2009
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression Mood Disorders Depressive Disorder||Drug: Citalopram||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional MRI Before and After Treatment for Depression|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||June 2014|
Experimental: Depressed patients
Depressed patients assigned in an open-label study of citalopram
Refer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram.
Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition.
Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition.
Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition.
Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression.
Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI.
No Intervention: Controls
Healthy controls used as a comparison (no intervention) group for change in resting-state fMRI over time
- Hamilton Depression Rating Scale Percent Change From Day 0 to D56 [ Time Frame: % change from baseline to Day 56 ( week 8) ]Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression
- Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex [ Time Frame: baseline and week 8 ]The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.
- Hamilton Anxiety Scale [ Time Frame: % change in anxiety from Day 1 to Day 56 (week 8) ]Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896441
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Michael D Greicius||Stanford University|