Status:
COMPLETED
Brain Imaging Techniques That Predict Antidepressant Responsiveness
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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?
Detailed Description
This is a single site, controlled, double-blind study of outpatients. There are two arms: 1. Forty participants who have a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00909155
Start Date
July 1 2002
End Date
December 1 2009
Last Update
August 3 2018
Active Locations (1)
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1
University of Wisconsin Madison Psychiatry Department
Madison, Wisconsin, United States, 53719