Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
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

Participant Flow for 3 periods

Period 1:   Baseline

	Escitalopram	Placebo
STARTED	104	101
COMPLETED	104	101
NOT COMPLETED	0	0

Period 2:   Baseline to Week 4

	Escitalopram	Placebo
STARTED	104	101
COMPLETED	101	99
NOT COMPLETED	3	2
No diary or lost or withdrew	3	2

Period 3:   Week 4 to Week 8

	Escitalopram	Placebo
STARTED	101	99
COMPLETED	97	97
NOT COMPLETED	4	2
No diary or lost or withdrew	4	2

Reporting Groups

	Description
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 Measures

	Escitalopram	Placebo	Total
Number of Participants   [units: participants]	104	101	205
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	104	101	205
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	53.45  ± 4.20	54.36  ± 3.86	53.9  ± 4.0
Gender   [units: participants]
Female	104	101	205
Male	0	0	0
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	47	48	95
White	53	49	102
More than one race	0	0	0
Unknown or Not Reported	4	4	8
Region of Enrollment   [units: participants]
United States	104	101	205
Menopausal Status   [units: participants]
Postmenopause	84	83	167
Late transition	17	15	32
Early transition	3	3	6
Body Mass Index (BMI) [1] [units: participants]
<25, kg/m^2	32	22	54
25-<30, kg/m^2	34	38	72
>=30, kg/m^2	38	40	78
Missing data	0	1	1
Hysterectomy   [units: participants]
Hysterectomy	13	13	26
Hysterectomy and oophorectomy	11	8	19
Oophorectomy only	3	1	4
None	77	78	155
Don't know	0	1	1

1.  Primary:

Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries   [ Time Frame: Baseline ]

2.  Primary:

Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries   [ Time Frame: week 4 minus baseline ]

3.  Primary:

Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries   [ Time Frame: week 8 minus baseline ]

4.  Primary:

Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries   [ Time Frame: Baseline ]

5.  Primary:

Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries   [ Time Frame: week 4 minus baseline ]

6.  Primary:

Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries   [ Time Frame: week 8 minus baseline ]

7.  Secondary:

Daily Hot Flash Bother, Recorded on Daily Diaries   [ Time Frame: Baseline ]

8.  Secondary:

Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries   [ Time Frame: week 4 minus baseline ]

9.  Secondary:

Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries   [ Time Frame: week 8 minus baseline ]