Trial Outcomes & Findings for MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women (NCT NCT00894543)
NCT ID: NCT00894543
Last Updated: 2013-03-08
Results Overview
Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
week 4 minus baseline
Results posted on
2013-03-08
Participant Flow
Participants were recruited from July 2009 to June 2010. The trial was conducted at four MsFLASH network sites: University of Pennsylvania, Massachusetts General Hospital, Indiana University, Kaiser Permanente Division of Research in Oakland, California
Following enrollment (signing the consent), symptoms and health were reviewed, brief physical exam conducted and urine pregnancy test administered, daily hot flash diaries completed for one week (in addition to two weeks before enrollment).
Participant milestones
| Measure |
Escitalopram
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
Inactive pill
|
|---|---|---|
|
Baseline
STARTED
|
104
|
101
|
|
Baseline
COMPLETED
|
104
|
101
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Baseline to Week 4
STARTED
|
104
|
101
|
|
Baseline to Week 4
COMPLETED
|
101
|
99
|
|
Baseline to Week 4
NOT COMPLETED
|
3
|
2
|
|
Week 4 to Week 8
STARTED
|
101
|
99
|
|
Week 4 to Week 8
COMPLETED
|
97
|
97
|
|
Week 4 to Week 8
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Escitalopram
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
Inactive pill
|
|---|---|---|
|
Baseline to Week 4
No diary or lost or withdrew
|
3
|
2
|
|
Week 4 to Week 8
No diary or lost or withdrew
|
4
|
2
|
Baseline Characteristics
MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
Baseline characteristics by cohort
| Measure |
Escitalopram
n=104 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=101 Participants
Inactive pill
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
104 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
53.45 years
STANDARD_DEVIATION 4.20 • n=99 Participants
|
54.36 years
STANDARD_DEVIATION 3.86 • n=107 Participants
|
53.9 years
STANDARD_DEVIATION 4.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
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
|
47 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=99 Participants
|
101 participants
n=107 Participants
|
205 participants
n=206 Participants
|
|
Menopausal Status
Postmenopause
|
84 participants
n=99 Participants
|
83 participants
n=107 Participants
|
167 participants
n=206 Participants
|
|
Menopausal Status
Late transition
|
17 participants
n=99 Participants
|
15 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Menopausal Status
Early transition
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Body Mass Index (BMI)
<25, kg/m^2
|
32 participants
n=99 Participants
|
22 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Body Mass Index (BMI)
25-<30, kg/m^2
|
34 participants
n=99 Participants
|
38 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Body Mass Index (BMI)
>=30, kg/m^2
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Body Mass Index (BMI)
Missing data
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Hysterectomy
Hysterectomy
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Hysterectomy
Hysterectomy and oophorectomy
|
11 participants
n=99 Participants
|
8 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Hysterectomy
Oophorectomy only
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Hysterectomy
None
|
77 participants
n=99 Participants
|
78 participants
n=107 Participants
|
155 participants
n=206 Participants
|
|
Hysterectomy
Don't know
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineBaseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.
Outcome measures
| Measure |
Escitalopram
n=104 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=101 Participants
Inactive pill
|
|---|---|---|
|
Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries
|
9.88 Hot flashes/day
Interval 8.67 to 11.1
|
9.66 Hot flashes/day
Interval 8.7 to 10.63
|
PRIMARY outcome
Timeframe: week 4 minus baselineChange in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.
Outcome measures
| Measure |
Escitalopram
n=101 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=99 Participants
Inactive pill
|
|---|---|---|
|
Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
|
-4.37 Hot flashes/day
Interval -5.24 to -3.5
|
-2.49 Hot flashes/day
Interval -3.31 to -1.66
|
PRIMARY outcome
Timeframe: week 8 minus baselineChange in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.
Outcome measures
| Measure |
Escitalopram
n=97 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=97 Participants
Inactive pill
|
|---|---|---|
|
Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
|
-4.60 Hot flashes/day
Interval -5.47 to -3.74
|
-3.20 Hot flashes/day
Interval -4.15 to -2.24
|
PRIMARY outcome
Timeframe: BaselinePopulation: Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=104 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=101 Participants
Inactive pill
|
|---|---|---|
|
Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries
|
2.16 Scores on a scale
Interval 2.07 to 2.24
|
2.19 Scores on a scale
Interval 2.1 to 2.28
|
PRIMARY outcome
Timeframe: week 4 minus baselinePopulation: Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=100 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=97 Participants
Inactive pill
|
|---|---|---|
|
Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
|
-0.43 Scores on a scale
Interval -0.54 to -0.33
|
-0.23 Scores on a scale
Interval -0.34 to -0.13
|
PRIMARY outcome
Timeframe: week 8 minus baselinePopulation: Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Change in daily hot flash severity between baseline \& week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=96 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=96 Participants
Inactive pill
|
|---|---|---|
|
Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
|
-0.53 Scores on a scale
Interval -0.64 to -0.4
|
-0.30 Scores on a scale
Interval -0.42 to -0.17
|
SECONDARY outcome
Timeframe: BaselinePopulation: Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).
Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=104 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=101 Participants
Inactive pill
|
|---|---|---|
|
Daily Hot Flash Bother, Recorded on Daily Diaries
|
3.12 Scores on a scale
Interval 3.03 to 3.22
|
3.16 Scores on a scale
Interval 3.06 to 3.26
|
SECONDARY outcome
Timeframe: week 4 minus baselinePopulation: Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).
Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=100 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=97 Participants
Inactive pill
|
|---|---|---|
|
Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries
|
-0.59 Scores on a scale
Interval -0.73 to -0.45
|
-0.29 Scores on a scale
Interval -0.41 to -0.16
|
SECONDARY outcome
Timeframe: week 8 minus baselinePopulation: Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot). Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment.
Change in daily hot flash bother between baseline \& week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).
Outcome measures
| Measure |
Escitalopram
n=96 Participants
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=96 Participants
Inactive pill
|
|---|---|---|
|
Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries
|
-0.63 Scores on a scale
Interval -0.78 to -0.49
|
-0.39 Scores on a scale
Interval -0.55 to -0.24
|
Adverse Events
Escitalopram
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Escitalopram
n=104 participants at risk
Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
|
Placebo
n=101 participants at risk
Inactive pill
|
|---|---|---|
|
General disorders
Fatigue, tiredness
|
13.5%
14/104 • Number of events 14 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
13.9%
14/101 • Number of events 14 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Difficulty sleeping/insomnia
|
8.7%
9/104 • Number of events 9 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
9.9%
10/101 • Number of events 10 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Drowsiness
|
13.5%
14/104 • Number of events 14 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
12.9%
13/101 • Number of events 13 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Increased sweating
|
6.7%
7/104 • Number of events 7 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
8.9%
9/101 • Number of events 9 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Dry mouth
|
10.6%
11/104 • Number of events 11 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
11.9%
12/101 • Number of events 12 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Stomach or intestinal problems
|
9.6%
10/104 • Number of events 10 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
17.8%
18/101 • Number of events 18 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Nausea or vomiting
|
10.6%
11/104 • Number of events 11 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
5.0%
5/101 • Number of events 5 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Decreased sexual desire/ability
|
6.7%
7/104 • Number of events 7 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
7.9%
8/101 • Number of events 8 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Headache
|
7.7%
8/104 • Number of events 8 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
10.9%
11/101 • Number of events 11 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Vivid dreams
|
7.7%
8/104 • Number of events 8 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
8.9%
9/101 • Number of events 9 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Appetite changes
|
5.8%
6/104 • Number of events 6 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
4.0%
4/101 • Number of events 4 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Other symptoms
|
3.8%
4/104 • Number of events 4 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
9.9%
10/101 • Number of events 10 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
|
General disorders
Dizziness/lightheadedness
|
2.9%
3/104 • Number of events 3 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
6.9%
7/101 • Number of events 7 • Adverse events were collected during the 8 week treatment period.
Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
|
Additional Information
Dr. Ellen W. Freeman
University of Pennsylvania School of Medicine
Phone: 215-349-5521
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place