Brain Imaging Techniques That Predict Antidepressant Responsiveness

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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?

Key facts

Study ID

NCT00909155

Run by

University of Wisconsin, Madison

People needed

50

Starts

2002-07-01

Expected to finish

2009-12-01

Last updated by the study team

2018-08-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Wisconsin Madison Psychiatry Department — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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