Trial Outcomes & Findings for Connectivity Affecting the Antidepressant REsponse Study (NCT NCT02332291)
NCT ID: NCT02332291
Last Updated: 2021-09-21
Results Overview
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated measure of depression severity. Higher scores indicate greater depression severity, ranging 0-60. This will be used to define remission as a final score of 7 or less
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
From Baseline up to Week 16
Results posted on
2021-09-21
Participant Flow
Enrollment opened in April 2015, with the first participant enrolled in June 2015. Enrollment remained open through March 2020. Recruitment involved outpatients at Vanderbilt University Medical Center, recruited through clinical referrals and community advertisements.
Participants enrolled while on an antidepressant medication had that medication discontinued over several weeks. At least two weeks elapsed between last antidepressant use and randomization. Participants enrolled at screening were excluded from the study before baseline and randomization due to a) identification of potential MRI contraindications or b) remission of depression symptoms before the baseline visit.
Participant milestones
| Measure |
Blinded Escitalopram / Open-Label Bupropion
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Phase 1: Blinded Escitalopram or Placebo
STARTED
|
63
|
32
|
|
Phase 1: Blinded Escitalopram or Placebo
COMPLETED
|
59
|
23
|
|
Phase 1: Blinded Escitalopram or Placebo
NOT COMPLETED
|
4
|
9
|
|
Phase 2: Open-Label Bupropion
STARTED
|
22
|
19
|
|
Phase 2: Open-Label Bupropion
COMPLETED
|
19
|
11
|
|
Phase 2: Open-Label Bupropion
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
Blinded Escitalopram / Open-Label Bupropion
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Phase 1: Blinded Escitalopram or Placebo
Adverse Event
|
3
|
5
|
|
Phase 1: Blinded Escitalopram or Placebo
Worsening Depression
|
0
|
4
|
|
Phase 1: Blinded Escitalopram or Placebo
Withdrawal by Subject
|
1
|
0
|
|
Phase 2: Open-Label Bupropion
Adverse Event
|
2
|
7
|
|
Phase 2: Open-Label Bupropion
Worsening Depression
|
0
|
1
|
|
Phase 2: Open-Label Bupropion
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Connectivity Affecting the Antidepressant REsponse Study
Baseline characteristics by cohort
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=63 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=32 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.38 years
STANDARD_DEVIATION 4.86 • n=99 Participants
|
66.44 years
STANDARD_DEVIATION 4.81 • n=107 Participants
|
66.40 years
STANDARD_DEVIATION 4.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
32 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
26.32 units on a scale
STANDARD_DEVIATION 5.00 • n=99 Participants
|
25.78 units on a scale
STANDARD_DEVIATION 6.29 • n=107 Participants
|
26.14 units on a scale
STANDARD_DEVIATION 5.44 • n=206 Participants
|
|
Mini-Mental State Exam (MMSE) Score
|
29.43 units on a scale
STANDARD_DEVIATION 0.87 • n=99 Participants
|
29.22 units on a scale
STANDARD_DEVIATION 1.21 • n=107 Participants
|
29.36 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 16Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated measure of depression severity. Higher scores indicate greater depression severity, ranging 0-60. This will be used to define remission as a final score of 7 or less
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=63 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=32 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Number of Patients With Remission of Depression
|
37 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 8Depression severity was measured by a study clinician using the MADRS. Higher scores indicate greater depression severity, ranging 0-60. Change calculated as Final MADRS - Baseline MADRS, so a negative score means greater improvement.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=63 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=32 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Change in Depression Severity, Clinician Rated
|
-13.90 score on a scale
Standard Deviation 9.38
|
-6.09 score on a scale
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: Baseline to week 8Self-rated depression severity was measured by the Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report of depression severity ranging from 0-27, with higher scores indicating greater depression severity.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=63 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=32 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Change in Depression Severity, Self Rated
|
-4.87 units on a scale
Standard Deviation 5.33
|
-2.09 units on a scale
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Week 8 to week 16Change in depression severity will be measured by the MADRS. Higher scores indicate greater depression severity, ranging 0-60. Change calculated as Final MADRS - Baseline MADRS, so a negative score means greater improvement.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=41 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Change in Depression Severity, Clinician Rated
|
-8.75 units on a scale
Standard Deviation 8.27
|
—
|
SECONDARY outcome
Timeframe: Week 8 to week 16Change in self-reported depression severity was measured by the Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). This scale ranges from 0-27, with higher scores indicating greater depression severity. Change is calculated as final score less baseline score, so a negative value indicates a decrease in depression severity.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=41 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Change in Depression Severity, Self Rated
|
-2.83 units on a scale
Standard Deviation 3.85
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Population: Only 72 subjects out of possible 95 individuals included, as both baseline and week 8 AES data were missing for 23 participants who did not complete the self-report questionnaire.
The AES is a self-report scale of apathy symptoms. The scale ranges from 18-72, with higher scores indicating greater levels of apathy. Change is calculated as final AES score - baseline AES score, so a more negative value indicates greater improvement in that symptom.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=50 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=22 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Apathy Evaluation Scale (AES)
|
-4.52 units on a scale
Standard Deviation 7.72
|
-3.00 units on a scale
Standard Deviation 8.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Population: Only 71 participants out of a possible 95 were included in analyses as either baseline or week 8 RRS data were missing for the remaining 24 participants, who did not complete the questionnaire.
The RRS is a self-report questionnaire assessing rumination, or responding to distress by passively focusing on the possible causes and consequences of one's distress. The RRS ranges from scores of 0-66, with higher scores indicating greater severity of rumination. Change is calculated as final RRS score - baseline RRS score, so a negative change indicates improvement in this symptom.
Outcome measures
| Measure |
Blinded Escitalopram / Open-Label Bupropion
n=49 Participants
8 weeks of blinded escitalopram. Remission status then assessed. If not remitting, blinded escitalopram is stopped and participants begin 8 weeks of open-label bupropion xl
Escitalopram: Escitalopram 10-20mg daily
Bupropion XL: Bupropion XL 150-450mg daily
|
Blinded Placebo / Open-Label Bupropion
n=22 Participants
8 weeks of blinded placebo. Remission status then assessed. If not remitting, blinded placebo is stopped and participants begin 8 weeks of open-label bupropion xl
Placebo: 1-2 tablets daily
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|
|
Ruminative Response Scale (RRS)
|
-10.27 units on a scale
Standard Deviation 9.96
|
-5.41 units on a scale
Standard Deviation 10.22
|
Adverse Events
Blinded Escitalopram
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Blinded Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Open-Label Bupropion
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinded Escitalopram
n=63 participants at risk
8 weeks of blinded escitalopram
Escitalopram: Escitalopram 10-20mg daily
|
Blinded Placebo
n=32 participants at risk
8 weeks of blinded placebo
Placebo: Placebo 1-2 tablets daily
|
Open-Label Bupropion
n=41 participants at risk
8-weeks of open-label treatment with bupropion following initial randomization phase for individuals who did not remit to treatment with either blinded escitalopram or placebo.
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Nervous system disorders
Stroke, ischemic
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
General disorders
Dehydration
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
Other adverse events
| Measure |
Blinded Escitalopram
n=63 participants at risk
8 weeks of blinded escitalopram
Escitalopram: Escitalopram 10-20mg daily
|
Blinded Placebo
n=32 participants at risk
8 weeks of blinded placebo
Placebo: Placebo 1-2 tablets daily
|
Open-Label Bupropion
n=41 participants at risk
8-weeks of open-label treatment with bupropion following initial randomization phase for individuals who did not remit to treatment with either blinded escitalopram or placebo.
Bupropion XL: Bupropion XL 150-450mg daily
|
|---|---|---|---|
|
Cardiac disorders
Irregular Heartbeat
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
General disorders
Dry mouth
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
6/63 • Number of events 6 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
4.9%
2/41 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Gastrointestinal disorders
Nausea
|
12.7%
8/63 • Number of events 8 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Injury, poisoning and procedural complications
Minor Environmental Injury
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Nervous system disorders
Dizziness / Lightheaded
|
7.9%
5/63 • Number of events 5 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
4.9%
2/41 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Nervous system disorders
Headache
|
4.8%
3/63 • Number of events 3 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
4.9%
2/41 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Psychiatric disorders
Anxiety / Tension
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
19.5%
8/41 • Number of events 8 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
9.8%
4/41 • Number of events 4 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Psychiatric disorders
Increased dreaming
|
4.8%
3/63 • Number of events 3 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
7.3%
3/41 • Number of events 3 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
General disorders
Diaphoresis
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Vascular disorders
Edema, peripheral
|
0.00%
0/63 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
General disorders
Fatigue
|
12.7%
8/63 • Number of events 8 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
General disorders
Hot flashes
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
11.1%
7/63 • Number of events 7 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Gastrointestinal disorders
Appetite loss
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Infections and infestations
Upper Respiratory Infection
|
4.8%
3/63 • Number of events 3 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia / Myalgia
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Eye disorders
Blurred vision
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
|
Eye disorders
Diplopia
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/32 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
0.00%
0/41 • Adverse event data were collected during participants' duration in the study following randomization. This lasted for 8 weeks for the randomized, blinded escitalopram or placebo phase, and an additional 8 weeks for individuals progressing into the subsequent open-label bupropion phase.
|
Additional Information
Warren D. Taylor, MD, MHSc
Vanderbilt University Medical Center
Phone: 615-322-1073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place