Trial Outcomes & Findings for Brain Imaging Techniques That Predict Antidepressant Responsiveness (NCT NCT00909155)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Study entry, 2 months, and at end of study (6 mos)

Results posted on

2018-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Currently Depressed Subjects: Venlafaxine 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: Fluoxetine 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	Control (Non-psychiatric Subjects) Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Overall Study STARTED	15	14	21
Overall Study COMPLETED	12	9	14
Overall Study NOT COMPLETED	3	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Imaging Techniques That Predict Antidepressant Responsiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Currently Depressed Subjects: Venlafaxine n=15 Participants 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: Fluoxetine n=14 Participants 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	Control (Non-psychiatric Subjects) n=21 Participants Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	14 Participants n=4 Participants	21 Participants n=27 Participants	50 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	30.74 years STANDARD_DEVIATION 11.46 • n=93 Participants	33.14 years STANDARD_DEVIATION 10.71 • n=4 Participants	31.31 years STANDARD_DEVIATION 14.22 • n=27 Participants	31.65 years STANDARD_DEVIATION 12.31 • n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants	29 Participants n=483 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants	21 Participants n=483 Participants
Region of Enrollment United States	15 participants n=93 Participants	14 participants n=4 Participants	21 participants n=27 Participants	50 participants n=483 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Currently Depressed Subjects: Venlafaxine n=15 Participants 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: Fluoxetine n=14 Participants 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	Control (Non-psychiatric Subjects) n=21 Participants Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMD 2months	8.86 units on a scale Standard Deviation 4.5	10.15 units on a scale Standard Deviation 4.52	1.25 units on a scale Standard Deviation 1.34
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMA 2months	7.5 units on a scale Standard Deviation 4.55	8.54 units on a scale Standard Deviation 4.86	NA units on a scale Standard Deviation NA HAMA not collected on control subjects.
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMD 6months	5 units on a scale Standard Deviation 3.67	7.33 units on a scale Standard Deviation 4.92	1.64 units on a scale Standard Deviation 1.22
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMA 6months	4.25 units on a scale Standard Deviation 3.36	5.89 units on a scale Standard Deviation 3.86	NA units on a scale Standard Deviation NA HAMA not collected on control subjects.
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMA T0	14.07 units on a scale Standard Deviation 3.37	15.57 units on a scale Standard Deviation 3.82	NA units on a scale Standard Deviation NA HAMA not collected on control subjects.
Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales HAMD T0	20.07 units on a scale Standard Deviation 1.94	21.36 units on a scale Standard Deviation 2.71	1 units on a scale Standard Deviation 1.55

PRIMARY outcome

Timeframe: At study entry, 2 months and end of study (6 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Currently Depressed Subjects: Venlafaxine n=12 Participants 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: Fluoxetine n=9 Participants 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	Control (Non-psychiatric Subjects) Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.	-0.042666667 fMRI signal change Standard Deviation 0.291892646	0.0414 fMRI signal change Standard Deviation 0.332904397	—

Adverse Events

Currently Depressed Subjects; Venlafaxine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Currently Depressed Subjects; Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Non-psychiatric Subjects)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Peterson

University of Wisconsin

Phone: 608 265 8130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place