Brain Imaging Techniques That Predict Antidepressant Responsiveness

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Antidepressive Agents; Fluoxetine; Venlafaxine Hydrochloride

Criteria

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.