Trial Outcomes & Findings for Stress & Premenstrual Symptoms Study (NCT NCT02777372)
NCT ID: NCT02777372
Last Updated: 2025-06-12
Results Overview
Acoustic startle response (ASR) is measured during the follicular and luteal phase of the menstrual cycle in controls and those with PMDD. Magnitude of ASR is measured using the eyeblink reflex, by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak amplitude of the blink reflex was determined in the 20-120-ms time frame following stimulus onset relative to baseline (baseline is the average baseline electromyography (EMG) level for the 50 ms immediately preceding auditory stimulus onset). ASR is measured in microvolts, and raw ASR results are standardized to t-scores. Higher ASR t-score indicates greater contraction of the the orbicularis oculi muscle. A t-score of 50 indicates the population mean with a standard deviation of 10.
COMPLETED
PHASE4
84 participants
Month 1 (Follicular), Month 2 (Luteal)
2025-06-12
Participant Flow
Participant milestones
| Measure |
Control
Controls do not receive sertraline.
|
Sertraline
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine luteinizing hormone (LH) Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress & Premenstrual Symptoms Study
Baseline characteristics by cohort
| Measure |
Control
n=43 Participants
Controls do not receive sertraline.
|
Sertraline
n=41 Participants
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1 (Follicular), Month 2 (Luteal)Population: 33 Controls and 24 PMDD (Sertraline) completed the Month 1 (Follicular) visit, and 27 Controls and 23 premenstrual mood dysphoric disorder (PMDD) completed the Month 2 (Luteal) visit. Assessments were done on 1 day of the Follicular phase and 1 day of the Luteal phase.
Acoustic startle response (ASR) is measured during the follicular and luteal phase of the menstrual cycle in controls and those with PMDD. Magnitude of ASR is measured using the eyeblink reflex, by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. For the primary outcome of baseline ASR magnitude over the menstrual cycle, peak amplitude of the blink reflex was determined in the 20-120-ms time frame following stimulus onset relative to baseline (baseline is the average baseline electromyography (EMG) level for the 50 ms immediately preceding auditory stimulus onset). ASR is measured in microvolts, and raw ASR results are standardized to t-scores. Higher ASR t-score indicates greater contraction of the the orbicularis oculi muscle. A t-score of 50 indicates the population mean with a standard deviation of 10.
Outcome measures
| Measure |
Control
n=33 Participants
Controls do not receive sertraline.
|
Sertraline
n=24 Participants
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
|---|---|---|
|
Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase
Month 1 (Follicular)
|
54.2 t score
Standard Deviation 4.4
|
53.7 t score
Standard Deviation 4.7
|
|
Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase
Month 2 (Luteal)
|
56.4 t score
Standard Deviation 4.8
|
53.3 t score
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Month 2 (Luteal), Month 3 (Luteal)Population: 27 Controls and 23 PMDD (Sertraline) completed Luteal Month 2, and 24 Controls and 23 PMDD completed Luteal Month 3. Assessments were done on 1 day of the Luteal phase in Month 2 and 1 day of the Luteal phase in Month 3.
This outcome examines the impact of luteal phase treatment with a selective serotonin reuptake inhibitor (SSRI) (PMDD group only) on acoustic startle response (ASR). ASR is measured using the eyeblink reflex, measured by recording activity from the orbicularis oculi muscle. Recording is performed via two surface disk electrodes (Ag-AgCl) applied underneath the left eye; one in line with the pupil and one 1-2 cm lateral to the first one. Peak amplitude of the blink reflex is determined in the 20-120-ms time frame following stimulus onset. PMDD participants complete test day 3 (Luteal Month 3) while on sertraline and their ASR magnitude will be compared to their previous luteal test day (Luteal Month 2). ASR is measured in microvolts, and raw ASR results are standardized to t-scores. Higher ASR t-score indicates greater contraction of the the orbicularis oculi muscle. A t-score of 50 indicates the population mean with a standard deviation of 10.
Outcome measures
| Measure |
Control
n=27 Participants
Controls do not receive sertraline.
|
Sertraline
n=23 Participants
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
|---|---|---|
|
Impact of Sertraline on ASR Magnitude
Month 2 (Luteal)
|
56.4 t score
Standard Deviation 4.8
|
53.3 t score
Standard Deviation 4.8
|
|
Impact of Sertraline on ASR Magnitude
Month 3 (Luteal)
|
51.8 t score
Standard Deviation 4.6
|
52.2 t score
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Month 1 (Follicular ), Month 2 (Luteal )Population: 38 participants in the Control group and 32 participants in the PMDD group had blood available for IL-6 measurement in the Follicular phase. 36 Controls and 32 PMDD had blood available for IL-6 in the Luteal 1 phase. Assessments were done on 1 day of the Follicular phase and 1 day of the Luteal phase.
Blood samples were collected to measure serum interleukin-6 (IL-6). IL-6 levels were compared in the follicular and luteal phases, between Control and PMDD groups. Levels are measured in picogram/milliliter (pg/mL).
Outcome measures
| Measure |
Control
n=38 Participants
Controls do not receive sertraline.
|
Sertraline
n=32 Participants
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
|---|---|---|
|
Interleukin 6 (IL-6) Level
Month 1 (Follicular)
|
0.4 picogram/milliliter (pg/mL)
Standard Deviation 0.19
|
.34 picogram/milliliter (pg/mL)
Standard Deviation .15
|
|
Interleukin 6 (IL-6) Level
Month 2 (Luteal)
|
.59 picogram/milliliter (pg/mL)
Standard Deviation .46
|
.4 picogram/milliliter (pg/mL)
Standard Deviation .17
|
SECONDARY outcome
Timeframe: Month 1 (Follicular ), Month 2 (Luteal )Population: 38 Controls and 32 PMDD had blood available to measure TNF-alpha in the Follicular phase. 36 Controls and 32 PMDD had blood available to measure TNF-alpha in the Luteal phase. Assessments were done on 1 day of the Follicular phase and 1 day of the Luteal phase.
Blood samples were collected to measure serum TNF-alpha levels in the Follicular and Luteal 1 phases. Levels are measured in picogram/milliliter (pg/mL).
Outcome measures
| Measure |
Control
n=38 Participants
Controls do not receive sertraline.
|
Sertraline
n=32 Participants
To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMD group only) on arousal regulation across the menstrual cycle.
Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
|
|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-alpha) Level
Month 1 (Follicular )
|
1.27 pg/mL
Standard Deviation .32
|
1.63 pg/mL
Standard Deviation .52
|
|
Tumor Necrosis Factor Alpha (TNF-alpha) Level
Month 2 (Luteal )
|
1.27 pg/mL
Standard Deviation .36
|
1.54 pg/mL
Standard Deviation .31
|
Adverse Events
Control
Sertraline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Liisa Hantsoo, Ph.D.
The Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place