Major Depressive Disorder Clinical Trial
— WyethKoldenOfficial title:
Non-Invasive Brain Imaging Techniques That Predict Antidepressant Responsiveness and Provide Insights Into the Mechanism of Action of Venlafaxine ER vs. Fluoxetine
Verified date | July 2018 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine treatment and do changes in selective structures, such as the amygdala, predict treatment response?
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Intervention Group: - Right-handed, - Be able to lie still on their back for about 120 minutes, - Meet DSM-IV criteria for major depression (single or recurrent), - Have had depressive symptoms for at least 1 month prior to screen visit, - Must score an 18 or above on the Hamilton-D at both the initial screening visit and first fMRI scanning session, - Able to understand and speak English. - Control Group: same as above with the exception of no diagnosis of psychiatric disorder. Exclusion Criteria: - Any history of seizures, - Current medical disorders that might make interpretation of scan data difficult, - Diabetes requiring insulin treatment, - A serious heart disorder or subjects who have had a heart attack within the last 3 months, - Subjects who meet DSM-IV criteria for alcohol/drug abuse or dependence within the last six months, - Other current DSM-IV Axis I or Axis II diagnoses, - A personal or family history of bipolar disorder, - Current use of medication that affects central nervous system (CNS) function, - Participation in the last 30 days in a clinical study involving an investigational drug, - A subject with metallic implants, such as prostheses, shrapnel or aneurysm clip-S, or persons with electronic implants, such as cardiac pacemakers. The magnetic field generated by the MRI machine can cause a displacement or malfunctioning of these devices. - A subject who is claustrophobic, - Female subjects who are pregnant, - A subject at serious risk for suicide, - Diagnosis of cancer in the past 3 years and/or has active neoplastic disease, - Nonresponse to 2 adequate trials of antidepressant treatment, - Nonresponse to 2 adequate trials of an empirically supported psychotherapy. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Madison Psychiatry Department | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Heller AS, Johnstone T, Light SN, Peterson MJ, Kolden GG, Kalin NH, Davidson RJ. Relationships between changes in sustained fronto-striatal connectivity and positive affect in major depression resulting from antidepressant treatment. Am J Psychiatry. 2013 — View Citation
Heller AS, Johnstone T, Peterson MJ, Kolden GG, Kalin NH, Davidson RJ. Increased prefrontal cortex activity during negative emotion regulation as a predictor of depression symptom severity trajectory over 6 months. JAMA Psychiatry. 2013 Nov;70(11):1181-9. — View Citation
Heller AS, Johnstone T, Shackman AJ, Light SN, Peterson MJ, Kolden GG, Kalin NH, Davidson RJ. Reduced capacity to sustain positive emotion in major depression reflects diminished maintenance of fronto-striatal brain activation. Proc Natl Acad Sci U S A. 2 — View Citation
Light SN, Heller AS, Johnstone T, Kolden GG, Peterson MJ, Kalin NH, Davidson RJ. Reduced right ventrolateral prefrontal cortex activity while inhibiting positive affect is associated with improvement in hedonic capacity after 8 weeks of antidepressant tre — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales | 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). |
Study entry, 2 months, and at end of study (6 mos) | |
Primary | Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task. | 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. |
At study entry, 2 months and end of study (6 months) |
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