Trial Outcomes & Findings for Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder (NCT NCT00536198)
NCT ID: NCT00536198
Last Updated: 2017-04-14
Results Overview
The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
252 participants
Primary outcome timeframe
Measured from baseline to Cycle 6
Results posted on
2017-04-14
Participant Flow
Three-center study; New Haven, CT; New York City, NY; Richmond, VA. Participants recruited via direct mail and advertisements. Assessed initially over phone, then face-to-face screening office visit. Screening took place between September 2007 and February 2012.
Participant milestones
| Measure |
Sertraline
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
127
|
|
Overall Study
Cycle 1
|
110
|
123
|
|
Overall Study
Cycle 2
|
104
|
112
|
|
Overall Study
Cycle 3
|
100
|
101
|
|
Overall Study
Cycle 4
|
95
|
98
|
|
Overall Study
Cycle 5
|
88
|
85
|
|
Overall Study
Cycle 6
|
88
|
88
|
|
Overall Study
COMPLETED
|
88
|
88
|
|
Overall Study
NOT COMPLETED
|
37
|
39
|
Reasons for withdrawal
| Measure |
Sertraline
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
14
|
|
Overall Study
Withdrawal by Subject
|
16
|
12
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Rescue
|
3
|
9
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Baseline characteristics by cohort
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 6.71 • n=99 Participants
|
34.6 years
STANDARD_DEVIATION 6.90 • n=107 Participants
|
34.17 years
STANDARD_DEVIATION 6.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
86 participants
n=99 Participants
|
89 participants
n=107 Participants
|
175 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/mixed/other
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=99 Participants
|
127 participants
n=107 Participants
|
252 participants
n=206 Participants
|
|
Education
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Some high school/high school graduate
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Education
Some college
|
40 participants
n=99 Participants
|
22 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Education
College/graduate or professional school
|
73 participants
n=99 Participants
|
94 participants
n=107 Participants
|
167 participants
n=206 Participants
|
|
Marital status
Married
|
51 participants
n=99 Participants
|
42 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Marital status
Living with partner
|
14 participants
n=99 Participants
|
20 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Marital status
Divorced/separated
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Marital status
Never married
|
49 participants
n=99 Participants
|
51 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Past Psychiatric Conditions: Major Depressive Disorder
Yes
|
35 participants
n=99 Participants
|
43 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Past Psychiatric Conditions: Major Depressive Disorder
No
|
90 participants
n=99 Participants
|
84 participants
n=107 Participants
|
174 participants
n=206 Participants
|
|
Baseline Length of Menstrual Cycle
|
27.92 days
STANDARD_DEVIATION 5.26 • n=99 Participants
|
27.02 days
STANDARD_DEVIATION 4.58 • n=107 Participants
|
27.4 days
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Baseline Luteal Phase Daily Rating of Severity of Problems Score
|
61.20 units on a scale
STANDARD_DEVIATION 20.09 • n=99 Participants
|
60.37 units on a scale
STANDARD_DEVIATION 17.37 • n=107 Participants
|
60.8 units on a scale
STANDARD_DEVIATION 18.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Measured from baseline to Cycle 6Population: all randomized participants
The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Premenstrual Tension Scale (PMTS)
Cycle 1
|
15.6 units on a scale
Standard Deviation 7.3
|
16.8 units on a scale
Standard Deviation 6.0
|
|
Premenstrual Tension Scale (PMTS)
Cycle 2
|
14.1 units on a scale
Standard Deviation 6.9
|
15.6 units on a scale
Standard Deviation 6.1
|
|
Premenstrual Tension Scale (PMTS)
Cycle 3
|
13.0 units on a scale
Standard Deviation 8.0
|
14.0 units on a scale
Standard Deviation 5.8
|
|
Premenstrual Tension Scale (PMTS)
Cycle 4
|
12.9 units on a scale
Standard Deviation 6.7
|
13.9 units on a scale
Standard Deviation 6.3
|
|
Premenstrual Tension Scale (PMTS)
Cycle 6
|
11.7 units on a scale
Standard Deviation 6.8
|
12.8 units on a scale
Standard Deviation 6.9
|
|
Premenstrual Tension Scale (PMTS)
Average change from baseline
|
-10.6 units on a scale
Standard Deviation 6.6
|
-8.9 units on a scale
Standard Deviation 7.4
|
|
Premenstrual Tension Scale (PMTS)
Baseline
|
22.3 units on a scale
Standard Deviation 4.8
|
21.4 units on a scale
Standard Deviation 4.5
|
|
Premenstrual Tension Scale (PMTS)
Cycle 5
|
11.4 units on a scale
Standard Deviation 6.3
|
12.4 units on a scale
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: Measured from baseline to Cycle 6Population: all participants enrolled were analyzed
Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Inventory of Depression Symptoms (IDS-C)
Baseline
|
35.4 units on a scale
Standard Deviation 10.7
|
32.8 units on a scale
Standard Deviation 10.4
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 1
|
23.7 units on a scale
Standard Deviation 12.3
|
24.0 units on a scale
Standard Deviation 11.4
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 2
|
21.0 units on a scale
Standard Deviation 11.7
|
22.8 units on a scale
Standard Deviation 10.6
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 3
|
19.2 units on a scale
Standard Deviation 13.1
|
19.6 units on a scale
Standard Deviation 10.0
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 4
|
17.3 units on a scale
Standard Deviation 11.1
|
19.1 units on a scale
Standard Deviation 9.9
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 5
|
15.2 units on a scale
Standard Deviation 9.9
|
16.7 units on a scale
Standard Deviation 10.4
|
|
Inventory of Depression Symptoms (IDS-C)
Cycle 6
|
15.5 units on a scale
Standard Deviation 10.7
|
17.8 units on a scale
Standard Deviation 11.0
|
|
Inventory of Depression Symptoms (IDS-C)
Average change from baseline
|
-20.0 units on a scale
Standard Deviation 11.4
|
-15.3 units on a scale
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Measured from Cycle 1 to Cycle 6Population: all participants enrolled were analyzed
Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Michelson SSRI Withdrawal Checklist
Cycle 1
|
72.9 units on a scale
Standard Deviation 29.3
|
68.1 units on a scale
Standard Deviation 25.4
|
|
Michelson SSRI Withdrawal Checklist
Cycle 2
|
73.4 units on a scale
Standard Deviation 29.9
|
75.2 units on a scale
Standard Deviation 33.1
|
|
Michelson SSRI Withdrawal Checklist
Cycle 3
|
70.3 units on a scale
Standard Deviation 27.9
|
71.7 units on a scale
Standard Deviation 39.0
|
|
Michelson SSRI Withdrawal Checklist
Cycle 5
|
63.9 units on a scale
Standard Deviation 19.9
|
62.1 units on a scale
Standard Deviation 24.0
|
|
Michelson SSRI Withdrawal Checklist
Cycle 6
|
67.5 units on a scale
Standard Deviation 22.1
|
76.2 units on a scale
Standard Deviation 34.1
|
|
Michelson SSRI Withdrawal Checklist
Cycle 4
|
62.3 units on a scale
Standard Deviation 25.1
|
65.4 units on a scale
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: Measured from Cycle 1 to Cycle 6Population: all participants enrolled were analyzed
The number of days that pills were taken on.
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Number of Days Pills Were Taken
Cycle 1
|
6.5 number of days
Standard Deviation 3.4
|
6.6 number of days
Standard Deviation 3.4
|
|
Number of Days Pills Were Taken
Cycle 2
|
7.4 number of days
Standard Deviation 3.3
|
6.7 number of days
Standard Deviation 3.3
|
|
Number of Days Pills Were Taken
Cycle 3
|
8.2 number of days
Standard Deviation 3.7
|
7.1 number of days
Standard Deviation 3.4
|
|
Number of Days Pills Were Taken
Cycle 4
|
7.0 number of days
Standard Deviation 3.8
|
6.9 number of days
Standard Deviation 3.4
|
|
Number of Days Pills Were Taken
Cycle 5
|
7.6 number of days
Standard Deviation 4.0
|
6.7 number of days
Standard Deviation 3.4
|
|
Number of Days Pills Were Taken
Cycle 6
|
6.9 number of days
Standard Deviation 3.8
|
6.1 number of days
Standard Deviation 3.7
|
|
Number of Days Pills Were Taken
Average Change from Cycle 1
|
0.3 number of days
Standard Deviation 4.2
|
-0.3 number of days
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Cycle 1 to Cycle 6Population: all enrolled participants were analyzed
Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least "3", which is a mean of at least mild.
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 1
|
2.8 days
Standard Deviation 3.0
|
2.6 days
Standard Deviation 3.0
|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 2
|
2.0 days
Standard Deviation 2.2
|
2.7 days
Standard Deviation 3.1
|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 3
|
1.9 days
Standard Deviation 2.8
|
2.0 days
Standard Deviation 2.7
|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 4
|
2.0 days
Standard Deviation 2.7
|
2.0 days
Standard Deviation 2.9
|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 5
|
1.9 days
Standard Deviation 2.9
|
1.8 days
Standard Deviation 2.4
|
|
Number of Symptomatic Days Before Pills Were Taken
Cycle 6
|
1.7 days
Standard Deviation 2.3
|
2.0 days
Standard Deviation 3.2
|
|
Number of Symptomatic Days Before Pills Were Taken
Average Change from Cycle 1
|
-0.7 days
Standard Deviation 3.4
|
-1.0 days
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline to Cycle 6DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be \>2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms.
Outcome measures
| Measure |
Sertraline
n=113 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=115 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
DRSP
Cycle 4
|
35.3 units on a scale
Standard Deviation 12.2
|
36.9 units on a scale
Standard Deviation 11.3
|
|
DRSP
Cycle 5
|
31.7 units on a scale
Standard Deviation 10.5
|
35.2 units on a scale
Standard Deviation 12.7
|
|
DRSP
Cycle 6
|
32.2 units on a scale
Standard Deviation 10.4
|
36.1 units on a scale
Standard Deviation 13.6
|
|
DRSP
Average change from baseline
|
-29.7 units on a scale
Standard Deviation 18.8
|
-22.4 units on a scale
Standard Deviation 16.0
|
|
DRSP
Baseline
|
60.3 units on a scale
Standard Deviation 19.5
|
59.5 units on a scale
Standard Deviation 17.3
|
|
DRSP
Cycle 1
|
43.7 units on a scale
Standard Deviation 17.4
|
46.1 units on a scale
Standard Deviation 17.2
|
|
DRSP
Cycle 2
|
38.7 units on a scale
Standard Deviation 15.8
|
44.4 units on a scale
Standard Deviation 17.5
|
|
DRSP
Cycle 3
|
36.8 units on a scale
Standard Deviation 15.7
|
40.7 units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline through Cycle 6Population: all participants enrolled analyzed
Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Clinical Global Severity (CGI-S)
Cycle 4
|
2.6 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
|
Clinical Global Severity (CGI-S)
Cycle 5
|
2.4 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 1.1
|
|
Clinical Global Severity (CGI-S)
Cycle 6
|
2.2 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.3
|
|
Clinical Global Severity (CGI-S)
Average change from baseline
|
-2.3 units on a scale
Standard Deviation 1.2
|
-1.9 units on a scale
Standard Deviation 1.4
|
|
Clinical Global Severity (CGI-S)
Baseline
|
4.5 units on a scale
Standard Deviation 0.7
|
4.5 units on a scale
Standard Deviation 0.6
|
|
Clinical Global Severity (CGI-S)
Cycle 1
|
3.4 units on a scale
Standard Deviation 1.0
|
3.8 units on a scale
Standard Deviation 0.9
|
|
Clinical Global Severity (CGI-S)
Cycle 2
|
3.1 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.1
|
|
Clinical Global Severity (CGI-S)
Cycle 3
|
2.8 units on a scale
Standard Deviation 1.3
|
3.0 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.
Outcome measures
| Measure |
Sertraline
n=113 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=115 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
DRSP Depression Subscale
Cycle 1
|
5.5 units on a scale
Standard Deviation 3.0
|
5.7 units on a scale
Standard Deviation 8.4
|
|
DRSP Depression Subscale
Cycle 2
|
4.8 units on a scale
Standard Deviation 2.7
|
4.9 units on a scale
Standard Deviation 2.4
|
|
DRSP Depression Subscale
Baseline
|
7.5 units on a scale
Standard Deviation 4.0
|
7.2 units on a scale
Standard Deviation 3.5
|
|
DRSP Depression Subscale
Cycle 3
|
4.6 units on a scale
Standard Deviation 2.7
|
4.6 units on a scale
Standard Deviation 2.0
|
|
DRSP Depression Subscale
Cycle 4
|
4.3 units on a scale
Standard Deviation 1.9
|
4.3 units on a scale
Standard Deviation 1.5
|
|
DRSP Depression Subscale
Cycle 5
|
3.9 units on a scale
Standard Deviation 1.6
|
4.2 units on a scale
Standard Deviation 1.8
|
|
DRSP Depression Subscale
Cycle 6
|
3.9 units on a scale
Standard Deviation 2.0
|
4.2 units on a scale
Standard Deviation 2.0
|
|
DRSP Depression Subscale
Average change from baseline
|
-4.0 units on a scale
Standard Deviation 4.0
|
-2.7 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.
Outcome measures
| Measure |
Sertraline
n=113 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=115 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
DRSP Physical Subscale
Cycle 2
|
8.2 units on a scale
Standard Deviation 3.7
|
8.8 units on a scale
Standard Deviation 3.8
|
|
DRSP Physical Subscale
Cycle 3
|
7.8 units on a scale
Standard Deviation 3.2
|
8.1 units on a scale
Standard Deviation 3.4
|
|
DRSP Physical Subscale
Cycle 4
|
7.4 units on a scale
Standard Deviation 3.2
|
7.3 units on a scale
Standard Deviation 2.8
|
|
DRSP Physical Subscale
Cycle 5
|
6.9 units on a scale
Standard Deviation 2.7
|
7.1 units on a scale
Standard Deviation 3.0
|
|
DRSP Physical Subscale
Baseline
|
10.6 units on a scale
Standard Deviation 3.6
|
10.6 units on a scale
Standard Deviation 3.9
|
|
DRSP Physical Subscale
Cycle 1
|
8.4 units on a scale
Standard Deviation 3.5
|
8.4 units on a scale
Standard Deviation 3.6
|
|
DRSP Physical Subscale
Cycle 6
|
6.9 units on a scale
Standard Deviation 2.6
|
7.4 units on a scale
Standard Deviation 2.9
|
|
DRSP Physical Subscale
Average change from baseline
|
-4.2 units on a scale
Standard Deviation 3.8
|
-2.9 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.
Outcome measures
| Measure |
Sertraline
n=113 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=115 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
DRSP Anger/Irritability Subscale
Baseline
|
6.4 units on a scale
Standard Deviation 2.2
|
6.3 units on a scale
Standard Deviation 2.1
|
|
DRSP Anger/Irritability Subscale
Cycle 1
|
4.1 units on a scale
Standard Deviation 1.9
|
4.6 units on a scale
Standard Deviation 2.1
|
|
DRSP Anger/Irritability Subscale
Cycle 4
|
3.2 units on a scale
Standard Deviation 1.4
|
3.8 units on a scale
Standard Deviation 1.6
|
|
DRSP Anger/Irritability Subscale
Cycle 5
|
2.9 units on a scale
Standard Deviation 1.3
|
3.5 units on a scale
Standard Deviation 1.7
|
|
DRSP Anger/Irritability Subscale
Cycle 6
|
2.8 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.5
|
|
DRSP Anger/Irritability Subscale
Cycle 2
|
3.5 units on a scale
Standard Deviation 1.7
|
4.5 units on a scale
Standard Deviation 2.3
|
|
DRSP Anger/Irritability Subscale
Cycle 3
|
3.3 units on a scale
Standard Deviation 1.7
|
4.0 units on a scale
Standard Deviation 1.9
|
|
DRSP Anger/Irritability Subscale
Average change from baseline
|
-3.7 units on a scale
Standard Deviation 2.2
|
-2.8 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Cycle 1 to Cycle 6Population: all participants who were measured at a visit past baseline were analyzed
The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.
Outcome measures
| Measure |
Sertraline
n=110 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=123 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 1
|
2.7 units on a scale
Standard Deviation 1.1
|
3.2 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 2
|
2.4 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 1.1
|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 3
|
2.3 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 4
|
2.1 units on a scale
Standard Deviation 1.2
|
2.5 units on a scale
Standard Deviation 1.3
|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 5
|
2.0 units on a scale
Standard Deviation 1.0
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Clinical Global Impressions-Improvement (CGI-I)
Cycle 6
|
1.8 units on a scale
Standard Deviation 0.9
|
2.2 units on a scale
Standard Deviation 1.3
|
|
Clinical Global Impressions-Improvement (CGI-I)
Average change from Cycle 1
|
-0.9 units on a scale
Standard Deviation 1.2
|
-0.8 units on a scale
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Cycle 6Population: all enrolled participants were analyzed
A measurement of frequency of adverse events by random assignment
Outcome measures
| Measure |
Sertraline
n=125 Participants
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 Participants
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
Adverse Events
Nausea
|
15 participants
|
35 participants
|
|
Adverse Events
Diarrhea
|
14 participants
|
22 participants
|
|
Adverse Events
Headache
|
19 participants
|
14 participants
|
|
Adverse Events
Insomnia
|
9 participants
|
22 participants
|
|
Adverse Events
Fatigue
|
14 participants
|
15 participants
|
|
Adverse Events
Mouth dryness
|
5 participants
|
13 participants
|
|
Adverse Events
Difficulty concentrating
|
9 participants
|
8 participants
|
|
Adverse Events
Anxiety, agitation
|
6 participants
|
10 participants
|
|
Adverse Events
Diaphoresis
|
10 participants
|
6 participants
|
|
Adverse Events
Dizziness/lightheadedness
|
6 participants
|
9 participants
|
Adverse Events
Sertraline
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sertraline
n=125 participants at risk
Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period
Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
|
Placebo
n=127 participants at risk
Participants will take similarly looking placebo during the symptomatic period
Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
|
|---|---|---|
|
General disorders
Headache
|
15.2%
19/125 • Number of events 19 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
11.0%
14/127 • Number of events 14 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Insomnia
|
7.2%
9/125 • Number of events 9 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
17.3%
22/127 • Number of events 22 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Fatigue
|
11.2%
14/125 • Number of events 14 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
11.8%
15/127 • Number of events 15 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Mouth Dryness
|
4.0%
5/125 • Number of events 5 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
10.2%
13/127 • Number of events 13 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Difficulty Concentrating
|
7.2%
9/125 • Number of events 9 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
6.3%
8/127 • Number of events 8 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
Psychiatric disorders
Anxiety, Agitation
|
4.8%
6/125 • Number of events 6 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
7.9%
10/127 • Number of events 10 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Diaphoresis
|
8.0%
10/125 • Number of events 10 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
4.7%
6/127 • Number of events 6 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
General disorders
Dizziness/lightheadedness
|
4.8%
6/125 • Number of events 6 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
7.1%
9/127 • Number of events 9 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
15/125 • Number of events 15 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
27.6%
35/127 • Number of events 35 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
|
Gastrointestinal disorders
Diarrhea
|
11.2%
14/125 • Number of events 14 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
17.3%
22/127 • Number of events 22 • The adverse event data was collected for all participants at each visit. The first visits were in November of 2007 and the trial ended in July of 2012. Adverse event data spanned that 4 and a half year time frame.
|
Additional Information
Kimberly A. Yonkers, M.D.
Yale University School of Medicine
Phone: 203-764-5914
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place