Trial Outcomes & Findings for Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study (NCT NCT00523705)

Results Overview

A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

baseline and 5 months.

Results posted on

2014-06-06

Participant Flow

The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.

During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score \>80 in each cycle was required for randomization.

Participant milestones

Participant milestones
Measure	Escitalopram Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Sugar Pill Placebo tablets matched to drug.
Overall Study STARTED	7	4
Overall Study COMPLETED	7	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Escitalopram Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Sugar Pill Placebo tablets matched to drug.
Overall Study No time for study.	0	1

Baseline Characteristics

Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=7 Participants Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Sugar Pill n=4 Participants Placebo tablets matched to drug.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 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	17.6 years STANDARD_DEVIATION 1.4 • n=99 Participants	17.3 years STANDARD_DEVIATION 1.3 • n=107 Participants	17.4 years STANDARD_DEVIATION 1.4 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	4 participants n=107 Participants	11 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 5 months.

A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.

Outcome measures

Outcome measures
Measure	Escitalopram n=7 Participants Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Sugar Pill n=4 Participants Placebo tablets matched to drug.
Subject Daily Symptom Rating Score. mean score at baseline	155.6 units on a scale Standard Deviation 55.3	169 units on a scale Standard Deviation 59.1
Subject Daily Symptom Rating Score. mean score at endpoint (5 months)	91.6 units on a scale Standard Deviation 54.2	121.3 units on a scale Standard Deviation 131.6

SECONDARY outcome

Timeframe: Throughout study

Population: Data not analyzed due to only 11 subjects.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout treatment

Population: Not analyzed due to small number of subjects

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study endpoint

Population: Not analyzed due to small number of subjects.

Outcome measures

Outcome data not reported

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Escitalopram n=7 participants at risk Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Sugar Pill n=4 participants at risk Placebo tablets matched to drug.
General disorders fatigue	42.9% 3/7 • Number of events 8 • 3 treatment months	0.00% 0/4 • 3 treatment months
Nervous system disorders headache	28.6% 2/7 • Number of events 2 • 3 treatment months	0.00% 0/4 • 3 treatment months
Gastrointestinal disorders nausea	14.3% 1/7 • Number of events 1 • 3 treatment months	0.00% 0/4 • 3 treatment months
General disorders insomnia	14.3% 1/7 • Number of events 1 • 3 treatment months	0.00% 0/4 • 3 treatment months
Reproductive system and breast disorders breast tenderness	14.3% 1/7 • Number of events 1 • 3 treatment months	0.00% 0/4 • 3 treatment months
Nervous system disorders dizziness	14.3% 1/7 • Number of events 1 • 3 treatment months	0.00% 0/4 • 3 treatment months
General disorders other	42.9% 3/7 • Number of events 6 • 3 treatment months	0.00% 0/4 • 3 treatment months

Additional Information

Ellen Freeman, Principal Investigator

University of Pennsylvania

Phone: 215 662-3329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place