Mode
Text Size
Log in / Sign up
N/A N=50 Randomized Quadruple-blind Basic Science

Brain Imaging Techniques That Predict Antidepressant Responsiveness

Major Depressive Disorder

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales — 20.07; 21.36; 1; 14.07 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Venlafaxine ERT (Drug); Fluoxetine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Wisconsin, Madison
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales
20.07; 21.36; 1; 14.07; 15.57; NA
PRIMARY
Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.
-0.042666667; 0.0414

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?

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00909155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search