Trial Outcomes & Findings for fMRI Study of Treatment Changes in Major Depression (NCT NCT01027559)
NCT ID: NCT01027559
Last Updated: 2018-07-17
Results Overview
MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
baseline visit and 8-week follow-up
Results posted on
2018-07-17
Participant Flow
Prior to being assigned to a group, 6 depressed participants dropped from the study before being assigned to treatment type.
Participant milestones
| Measure |
Depressed Group: CBT
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84.
|
Healthy Control Group
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
Depressed Group: Sertraline
Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
34
|
31
|
|
Overall Study
COMPLETED
|
20
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
fMRI Study of Treatment Changes in Major Depression
Baseline characteristics by cohort
| Measure |
Depressed Group: CBT
n=26 Participants
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84.
|
Depressed Group: SRT
n=31 Participants
Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.
|
Healthy Control Group
n=34 Participants
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.54 years
n=5 Participants
|
33.29 years
n=7 Participants
|
31.64 years
n=5 Participants
|
32.16 years
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
19 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
34 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline visit and 8-week follow-upPopulation: fMRI data from a total of 26 depressed participants randomized to receive CBT and 24 control participants was analyzed. The primary aim was to compare depressed and control participants to evaluate regional brain activation during an emotional task, both at baseline and 8-week follow-up. The primary regions analyzed were the amygdala and DLPFC.
MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
Outcome measures
| Measure |
Depressed Group
n=26 Participants
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Cognitive Behavioral Therapy: Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
|
Healthy Control Group
n=24 Participants
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
Depressed Group: Sertraline
Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Sertraline: Visits will involve dispensing medication, side effects assessment and Hamilton Depression Rating Scale (HAMD) administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.
|
|---|---|---|---|
|
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
Amygdala - baseline
|
-18.74 Voxels
Standard Deviation 98.45
|
2.71 Voxels
Standard Deviation 141.09
|
—
|
|
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
DLPFC - baseline
|
316.24 Voxels
Standard Deviation 199.83
|
411.2 Voxels
Standard Deviation 241.53
|
—
|
|
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
Amygdala - Time 2
|
-16.82 Voxels
Standard Deviation 108.55
|
-46.06 Voxels
Standard Deviation 97.10
|
—
|
|
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
DLPFC - Time 2
|
403.72 Voxels
Standard Deviation 248.02
|
421.51 Voxels
Standard Deviation 231.33
|
—
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Numbers may differ from Participant Flow but these are the totals of those participants who had data at this time point for the Hamilton Depression Rating Scale.
The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.
Outcome measures
| Measure |
Depressed Group
n=18 Participants
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Cognitive Behavioral Therapy: Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
|
Healthy Control Group
n=15 Participants
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
Depressed Group: Sertraline
n=14 Participants
Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Sertraline: Visits will involve dispensing medication, side effects assessment and Hamilton Depression Rating Scale (HAMD) administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
Baseline
|
19.94 units on a scale
Standard Deviation 5.23
|
1.38 units on a scale
Standard Deviation 1.33
|
20.79 units on a scale
Standard Deviation 3.98
|
|
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
Week 12
|
5.94 units on a scale
Standard Deviation 6.08
|
1.07 units on a scale
Standard Deviation 1.33
|
4.43 units on a scale
Standard Deviation 5.37
|
Adverse Events
Depressed Group: CBT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Healthy Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Depressed Group: SSRI (Selective Serotonin Re-Uptake Inhibitor
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Depressed Group: CBT
n=26 participants at risk
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84.
|
Healthy Control Group
n=34 participants at risk
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
Depressed Group: SSRI (Selective Serotonin Re-Uptake Inhibitor
n=31 participants at risk
Depressed participants randomized to receive setraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.
Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26
|
0.00%
0/34
|
19.4%
6/31
|
|
Nervous system disorders
Sedation/Drowsiness
|
15.4%
4/26
|
0.00%
0/34
|
54.8%
17/31
|
|
Nervous system disorders
Excitement/Weakness
|
11.5%
3/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Nervous system disorders
Headache
|
11.5%
3/26
|
0.00%
0/34
|
38.7%
12/31
|
|
Gastrointestinal disorders
Nausea/Vomitting
|
11.5%
3/26
|
0.00%
0/34
|
32.3%
10/31
|
|
Gastrointestinal disorders
Stomach/Abdominal Pain
|
7.7%
2/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Nervous system disorders
Irritability
|
19.2%
5/26
|
0.00%
0/34
|
25.8%
8/31
|
|
Nervous system disorders
Muscle Twitching
|
3.8%
1/26
|
0.00%
0/34
|
25.8%
8/31
|
|
Nervous system disorders
Tremor
|
3.8%
1/26
|
0.00%
0/34
|
12.9%
4/31
|
|
Nervous system disorders
Decreased Appetite
|
7.7%
2/26
|
0.00%
0/34
|
25.8%
8/31
|
|
Nervous system disorders
Increased Appetite
|
7.7%
2/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Nervous system disorders
Weight Gain
|
7.7%
2/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Nervous system disorders
Insomnia
|
3.8%
1/26
|
0.00%
0/34
|
22.6%
7/31
|
|
Immune system disorders
Dry Mouth
|
11.5%
3/26
|
0.00%
0/34
|
32.3%
10/31
|
|
Nervous system disorders
Decreased Libido
|
7.7%
2/26
|
0.00%
0/34
|
22.6%
7/31
|
|
Immune system disorders
Malaise
|
7.7%
2/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Nervous system disorders
Impaired Mentation
|
7.7%
2/26
|
0.00%
0/34
|
12.9%
4/31
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
3.8%
1/26
|
0.00%
0/34
|
12.9%
4/31
|
|
Ear and labyrinth disorders
Dizziness/Faintness
|
3.8%
1/26
|
0.00%
0/34
|
25.8%
8/31
|
|
Nervous system disorders
Sexual Dysfunction
|
0.00%
0/26
|
0.00%
0/34
|
19.4%
6/31
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26
|
0.00%
0/34
|
16.1%
5/31
|
|
Immune system disorders
Nasal Congestion
|
7.7%
2/26
|
0.00%
0/34
|
25.8%
8/31
|
|
Nervous system disorders
Excessive Sweating
|
7.7%
2/26
|
0.00%
0/34
|
12.9%
4/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
2/26
|
5.9%
2/34
|
3.2%
1/31
|
|
Vascular disorders
Chest Pain
|
3.8%
1/26
|
0.00%
0/34
|
6.5%
2/31
|
|
Psychiatric disorders
Panic
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
Nervous system disorders
Slurred Speech
|
7.7%
2/26
|
0.00%
0/34
|
3.2%
1/31
|
|
Ear and labyrinth disorders
Difficulty Hearing/Tinnitus
|
0.00%
0/26
|
0.00%
0/34
|
9.7%
3/31
|
|
Vascular disorders
Increased Libido
|
0.00%
0/26
|
0.00%
0/34
|
9.7%
3/31
|
|
Vascular disorders
Syncope
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
Eye disorders
Blurred Vision
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
General disorders
Increased Salivation
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
Cardiac disorders
Tachycardia/Palpitations
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
Reproductive system and breast disorders
Menstrual Irregularity
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
|
General disorders
Weight Loss
|
0.00%
0/26
|
0.00%
0/34
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Abnormal Muscle Tone/Movements
|
0.00%
0/26
|
0.00%
0/34
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place