N/A
Completed N=50
Brain Imaging Techniques That Predict Antidepressant Responsiveness
Source: ClinicalTrials.gov NCT00909155 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales — 20.07; 21.36; 1; 14.07 units on a scale
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?
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.