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Brain Imaging Techniques That Predict Antidepressant Responsiveness (WyethKolden)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Major Depressive Disorder
Interventions Drug: Venlafaxine ERT
Drug: Fluoxetine
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Currently Depressed Subjects: Venlafaxine Currently Depressed Subjects: Fluoxetine Control (Non-psychiatric Subjects)
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Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).

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.

Currently depressed subjects; Randomized medication treatment with Fluoxetine

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

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Period Title: Overall Study
Started 15 14 21
Completed 12 9 14
Not Completed 3 5 7
Arm/Group Title Currently Depressed Subjects: Venlafaxine Currently Depressed Subjects: Fluoxetine Control (Non-psychiatric Subjects) Total
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Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT

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.

Currently depressed subjects; Randomized medication treatment with Fluoxetine

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

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication Total of all reporting groups
Overall Number of Baseline Participants 15 14 21 50
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 21 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
21
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 21 participants 50 participants
30.74  (11.46) 33.14  (10.71) 31.31  (14.22) 31.65  (12.31)
[1]
Measure Description: Data from the fluoxetine and venlafaxine groups were combined for analysis as individual groups not large enough to provide sufficient statistical power to identify treatment differences between groups.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 21 participants 50 participants
Female
8
  53.3%
8
  57.1%
13
  61.9%
29
  58.0%
Male
7
  46.7%
6
  42.9%
8
  38.1%
21
  42.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 21 participants 50 participants
15 14 21 50
1.Primary Outcome
Title Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales
Time Frame Study entry, 2 months, and at end of study (6 mos)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Currently Depressed Subjects: Venlafaxine Currently Depressed Subjects: Fluoxetine Control (Non-psychiatric Subjects)
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Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT

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.

Currently depressed subjects; Randomized medication treatment with Fluoxetine

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

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Overall Number of Participants Analyzed 15 14 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
HAMD T0 20.07  (1.94) 21.36  (2.71) 1  (1.55)
HAMA T0 14.07  (3.37) 15.57  (3.82) NA [1]   (NA)
HAMD 2months 8.86  (4.5) 10.15  (4.52) 1.25  (1.34)
HAMA 2months 7.5  (4.55) 8.54  (4.86) NA [1]   (NA)
HAMD 6months 5  (3.67) 7.33  (4.92) 1.64  (1.22)
HAMA 6months 4.25  (3.36) 5.89  (3.86) NA [1]   (NA)
[1]
HAMA not collected on control subjects.
2.Primary Outcome
Title Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.
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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.

Time Frame At study entry, 2 months and end of study (6 months)
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Hide Analysis Population Description
Depressed subjects were treated with an SSRI or an SNRI, and assessed at 3 time points on an fMRI emotional response task. Differences in depression scores and changes in the fMRI responses were analyzed for changes to better understand the association between emotion regulation, depression, and treatment response.
Arm/Group Title Depressed; Venlafaxine Treatment Depressed; Fluoxetine Treatment Control
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Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months.

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.

12 subjects completed the treatment, and both the 2month and 6month fMRI scans.

Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months.

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.

9 subjects completed the treatment, and both the 2month and 6month fMRI scans.

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication.

Control subjects did not complete the 2month and 6month fMRI scans since no depression was present, no treatment given, and no change in mood state expected.

As such, no change in depression score could be calculated to provide a comparable measure in this group analysis. This analysis looked for functional imaging findings that correlated with improvement in depression symptoms.

Overall Number of Participants Analyzed 12 9 0
Mean (Standard Deviation)
Unit of Measure: fMRI signal change
-0.042666667  (0.291892646) 0.0414  (0.332904397)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Currently Depressed Subjects; Venlafaxine Currently Depressed Subjects; Fluoxetine Control (Non-psychiatric Subjects)
Hide Arm/Group Description

Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.

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.

Currently depressed subjects; Randomized medication treatment with Fluoxetine

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

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
All-Cause Mortality
Currently Depressed Subjects; Venlafaxine Currently Depressed Subjects; Fluoxetine Control (Non-psychiatric Subjects)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Currently Depressed Subjects; Venlafaxine Currently Depressed Subjects; Fluoxetine Control (Non-psychiatric Subjects)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Currently Depressed Subjects; Venlafaxine Currently Depressed Subjects; Fluoxetine Control (Non-psychiatric Subjects)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%)   0/21 (0.00%) 
Relatively small number of subjects. Not powered statistically to determine if either treatment arm (fluoxetine or venlafaxine) is superior.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Peterson
Organization: University of Wisconsin
Phone: 608 265 8130
EMail: mpeterson2@wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00909155     History of Changes
Other Study ID Numbers: 0600B-100953
2001-294 ( Other Identifier: HS IRB )
First Submitted: May 18, 2009
First Posted: May 27, 2009
Results First Submitted: December 3, 2014
Results First Posted: December 15, 2014
Last Update Posted: August 3, 2018