Brain Imaging Techniques That Predict Antidepressant Responsiveness (WyethKolden)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales [ Time Frame: Study entry, 2 months, and at end of study (6 mos) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
- Vitals [ Time Frame: each visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2002|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|