Trial Outcomes & Findings for Characteristics of Sleep Patterns in Young Adults With and Without Insomnia (NCT NCT00177216)

Results Overview

Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

69 participants

Primary outcome timeframe

post treatment minus baseline assessment battery. This averaged 100 days.

Results posted on

2016-03-30

Participant Flow

Recruitment period lasted from 1/1/2002 to 12/1/2007. Subjects were recruited from the general public via tv, newspaper, and radio advertisements and via mass mailings.

Subjects who did not meet DSM-IV criteria for primary insomnia, had apnea or periodic limb movement disorder, or had an exclusionary psychiatric diagnosis (generalized anxiety disorder, major depressive disorder, substance abuse) were excluded.

Participant milestones

Participant milestones
Measure	Experimental: Zolpidem The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.	Experimental: Excitalopram The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.	Placebo Comparator: Placebo A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Overall Study STARTED	26	23	20
Overall Study COMPLETED	20	20	19
Overall Study NOT COMPLETED	6	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Zolpidem The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.	Experimental: Excitalopram The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.	Placebo Comparator: Placebo A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Overall Study Withdrawal by Subject	6	3	1

Baseline Characteristics

Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Zolpidem n=26 Participants The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.	Experimental: Excitalopram n=23 Participants The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.	Placebo Comparator: Placebo n=20 Participants A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.	Total n=69 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	23 Participants n=7 Participants	20 Participants n=5 Participants	69 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	38.07 years STANDARD_DEVIATION 9.07 • n=5 Participants	34.49 years STANDARD_DEVIATION 9.34 • n=7 Participants	37.46 years STANDARD_DEVIATION 8.63 • n=5 Participants	36.67 years STANDARD_DEVIATION 9.05 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	23 participants n=7 Participants	20 participants n=5 Participants	69 participants n=4 Participants

PRIMARY outcome

Timeframe: post treatment minus baseline assessment battery. This averaged 100 days.

Population: Number of subjects who had total PSQI scores after at least 5 weeks of treatment. The PSQI requires that all questions be answered for a total score to be calculated. This analysis includes participants who did not complete the protocol and also omits those who has missing total scores due to missing items on the PSQI

Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.

Outcome measures

Outcome measures
Measure	Zolpidem n=21 Participants Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem	Escitalpram n=20 Participants Participants receiving an antidepressant, escitalopram	Placebo n=19 Participants Participants receiving a placebo
Change in Pittsburgh Sleep Quality Index	-0.86 difference score of PSQI total Standard Deviation 4.51	-3.15 difference score of PSQI total Standard Deviation 4.52	-3.32 difference score of PSQI total Standard Deviation 2.63

PRIMARY outcome

Timeframe: post treatment minus baseline. This averaged 69 days.

Population: The number of subjects with sleep diaries at baseline and after at least 5 weeks of treatment. Not all of these participants 'completed' the protocol

The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.

Outcome measures

Outcome measures
Measure	Zolpidem n=23 Participants Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem	Escitalpram n=21 Participants Participants receiving an antidepressant, escitalopram	Placebo n=19 Participants Participants receiving a placebo
Change in Diary Sleep Efficiency	3.20 diff score of diary Sleep Efficiency Standard Deviation 11.62	0.61 diff score of diary Sleep Efficiency Standard Deviation 11.65	4.87 diff score of diary Sleep Efficiency Standard Deviation 11.26

SECONDARY outcome

Timeframe: post treatment minus baseline PSG sleep studies. This averaged 70 days

Population: Number of subjects who had polysomnography at Week 9 and at pretreatment. Some of the participants who 'completed' the protocol did not have follow up sleep studies.

Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment.

Outcome measures

Outcome measures
Measure	Zolpidem n=17 Participants Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem	Escitalpram n=19 Participants Participants receiving an antidepressant, escitalopram	Placebo n=19 Participants Participants receiving a placebo
Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint	0.43 difference score for SE Standard Deviation 6.23	1.16 difference score for SE Standard Deviation 12.94	0.32 difference score for SE Standard Deviation 10.50

Adverse Events

Zolpidem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zolpidem n=26 participants at risk Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem	Escitalopram n=23 participants at risk Participants receiving an antidepressant, escitalopram	Placebo n=20 participants at risk Participants receiving a placebo
Vascular disorders Inpatient Hospitalization	0.00% 0/26	0.00% 0/23	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	Zolpidem n=26 participants at risk Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem	Escitalopram n=23 participants at risk Participants receiving an antidepressant, escitalopram	Placebo n=20 participants at risk Participants receiving a placebo
Skin and subcutaneous tissue disorders Skin irritation related to EEG electrode placement	0.00% 0/26	4.3% 1/23 • Number of events 1	0.00% 0/20
Eye disorders Collodian remover splashed in eye	0.00% 0/26	4.3% 1/23 • Number of events 1	0.00% 0/20

Additional Information

Jean Miewald

University of Pittsburgh

Phone: 412-246-6406

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place