Brain Imaging Techniques That Predict Antidepressant Responsiveness (WyethKolden)
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|ClinicalTrials.gov Identifier: NCT00909155|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : December 15, 2014
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Venlafaxine ERT Drug: Fluoxetine||Not Applicable|
This is a single site, controlled, double-blind study of outpatients. There are two arms:
- Forty participants who have a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM-IV-TR) diagnosis of Major Depression will be recruited. These subjects will be randomized to receive one of two antidepressant medications: Fluoxetine or Venlafaxine ER for the duration of the study. Subjects will gradually be titrated onto the medications and will be seen in the clinic up to 18 times for medication checks, to monitor side effects and depressive symptoms, including suicidal ideation. In the event of suicidal ideation, subjects will be withdrawn from the study and referred for immediate treatment.
- Twenty normal control subjects with no current or past DSM-IV-TR diagnosis and will receive no medication. Normal control subjects will have up to 5 visits while in the study.
Subjects will contact study staff to complete a phone screen and then eligible subjects will complete a clinic screen. Subjects will then be scheduled to attend the magnetic resonance imaging (MRI) simulation visit and if subjects continue to meet entrance criteria, they will be scheduled for the first MRI. Following the first MRI, subjects in the medication conditions will begin receiving medication.
All subjects will undergo 3 functional magnetic resonance imaging (fMRI)s during the study: at the beginning of the study, approximately 8 weeks and 26 weeks later. During the MRI, subjects will view slides with positive and negative emotional content. Subjects will complete various clinical interviews or rating scales assessing mood and side effects at each of the visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Non-Invasive Brain Imaging Techniques That Predict Antidepressant Responsiveness and Provide Insights Into the Mechanism of Action of Venlafaxine ER vs. Fluoxetine|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: Depressed; Venlafaxine treatment
Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months.
Drug: Venlafaxine ERT
Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.
Other Name: Effexor ER
Active Comparator: Depressed; Fluoxetine treatment
Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months.
Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
Other Name: Prozac
No Intervention: Control
Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
- Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales [ Time Frame: Study entry, 2 months, and at end of study (6 mos) ]
Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression).
Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety).
- Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task. [ Time Frame: At study entry, 2 months and end of study (6 months) ]
Depressed participants were scanned while viewing a sequence of positive and negative images; they were instructed to enhance or supress their emotional response to the image or to continue to attend. To examine brain function when regulating negative affect, we created contrast maps for each participant at all 3 time points by subtracting the attend condition from the suppress condition in response to negative stimuli. Data from all 3 scan sessions were used to assess treatment-induced change in brain activity when regulating emotion. Analyses examining change using difference scores (end vs. starting points), we subtracted initial HAMD score from final HAMD score. For fMRI analyses, in a voxelwise manner, we subtracted initial negative suppress vs attend from final negative suppress vs attend.
Control subjects were not depressed, repeat scans to assess change were not completed.
Reported results are from BA10, one of our areas of interest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909155
|United States, Wisconsin|
|University of Wisconsin Madison Psychiatry Department|
|Madison, Wisconsin, United States, 53719|
|Principal Investigator:||Gregory Kolden, Ph.D.||University of Wisconsin Madison Psychiatry Department|
|Principal Investigator:||Michael Peterson, MD, Ph.D.||University of Wisconsin Madison Psychiatry Department|