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Brain Imaging Techniques That Predict Antidepressant Responsiveness (WyethKolden)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909155
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : December 15, 2014
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE May 18, 2009
First Posted Date  ICMJE May 27, 2009
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE December 15, 2014
Last Update Posted Date August 3, 2018
Study Start Date  ICMJE July 2002
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales [ Time Frame: Study entry, 2 months, and at end of study (6 mos) ]
    Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression). Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety).
  • Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task. [ Time Frame: At study entry, 2 months and end of study (6 months) ]
    Depressed participants were scanned while viewing a sequence of positive and negative images; they were instructed to enhance or supress their emotional response to the image or to continue to attend. To examine brain function when regulating negative affect, we created contrast maps for each participant at all 3 time points by subtracting the attend condition from the suppress condition in response to negative stimuli. Data from all 3 scan sessions were used to assess treatment-induced change in brain activity when regulating emotion. Analyses examining change using difference scores (end vs. starting points), we subtracted initial HAMD score from final HAMD score. For fMRI analyses, in a voxelwise manner, we subtracted initial negative suppress vs attend from final negative suppress vs attend. Control subjects were not depressed, repeat scans to assess change were not completed. Reported results are from BA10, one of our areas of interest.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales [ Time Frame: Study entry, 2 months, and at end of study (6 mos) ]
  • fMRI response to an emotional regulation task. [ Time Frame: At study entry, 2 months and end of study (6 months) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
Vitals [ Time Frame: each visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Imaging Techniques That Predict Antidepressant Responsiveness
Official Title  ICMJE Non-Invasive Brain Imaging Techniques That Predict Antidepressant Responsiveness and Provide Insights Into the Mechanism of Action of Venlafaxine ER vs. Fluoxetine
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, text revised (DSM-IV-TR) diagnosis of Major Depression will be recruited. These subjects will be randomized to receive one of two antidepressant medications: Fluoxetine or Venlafaxine ER for the duration of the study. Subjects will gradually be titrated onto the medications and will be seen in the clinic up to 18 times for medication checks, to monitor side effects and depressive symptoms, including suicidal ideation. In the event of suicidal ideation, subjects will be withdrawn from the study and referred for immediate treatment.
  2. Twenty normal control subjects with no current or past DSM-IV-TR diagnosis and will receive no medication. Normal control subjects will have up to 5 visits while in the study.

Subjects will contact study staff to complete a phone screen and then eligible subjects will complete a clinic screen. Subjects will then be scheduled to attend the magnetic resonance imaging (MRI) simulation visit and if subjects continue to meet entrance criteria, they will be scheduled for the first MRI. Following the first MRI, subjects in the medication conditions will begin receiving medication.

All subjects will undergo 3 functional magnetic resonance imaging (fMRI)s during the study: at the beginning of the study, approximately 8 weeks and 26 weeks later. During the MRI, subjects will view slides with positive and negative emotional content. Subjects will complete various clinical interviews or rating scales assessing mood and side effects at each of the visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Venlafaxine ERT
    Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.
    Other Name: Effexor ER
  • Drug: Fluoxetine
    Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
    Other Name: Prozac
Study Arms  ICMJE
  • Active Comparator: Depressed; Venlafaxine treatment
    Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months.
    Intervention: Drug: Venlafaxine ERT
  • Active Comparator: Depressed; Fluoxetine treatment
    Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months.
    Intervention: Drug: Fluoxetine
  • No Intervention: Control
    Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
53
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909155
Other Study ID Numbers  ICMJE 0600B-100953
2001-294 ( Other Identifier: HS IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Gregory Kolden, Ph.D. University of Wisconsin Madison Psychiatry Department
Principal Investigator: Michael Peterson, MD, Ph.D. University of Wisconsin Madison Psychiatry Department
PRS Account University of Wisconsin, Madison
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP