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Trial record 22 of 2228 for:    Symptoms | Parasomnias

Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

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ClinicalTrials.gov Identifier: NCT00177216
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Disorders
Interventions Drug: Zolpidem
Drug: Escitalopram
Drug: Placebo
Enrollment 69
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Experimental: Zolpidem Experimental: Excitalopram Placebo Comparator: Placebo
Hide Arm/Group Description 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. 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. A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Period Title: Overall Study
Started 26 23 20
Completed 20 20 19
Not Completed 6 3 1
Reason Not Completed
Withdrawal by Subject             6             3             1
Arm/Group Title Experimental: Zolpidem Experimental: Excitalopram Placebo Comparator: Placebo Total
Hide Arm/Group Description 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. 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. A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime. Total of all reporting groups
Overall Number of Baseline Participants 26 23 20 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 20 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
23
 100.0%
20
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 20 participants 69 participants
38.07  (9.07) 34.49  (9.34) 37.46  (8.63) 36.67  (9.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 20 participants 69 participants
Female
15
  57.7%
12
  52.2%
11
  55.0%
38
  55.1%
Male
11
  42.3%
11
  47.8%
9
  45.0%
31
  44.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 23 participants 20 participants 69 participants
26 23 20 69
1.Primary Outcome
Title Change in Pittsburgh Sleep Quality Index
Hide Description 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.
Time Frame post treatment minus baseline assessment battery. This averaged 100 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Experimental: Zolpidem Experimental: Excitalopram Placebo Comparator: Placebo
Hide Arm/Group Description:
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.
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.
A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Overall Number of Participants Analyzed 21 20 19
Mean (Standard Deviation)
Unit of Measure: difference score of PSQI total
-0.86  (4.51) -3.15  (4.52) -3.32  (2.63)
2.Primary Outcome
Title Change in Diary Sleep Efficiency
Hide Description 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.
Time Frame post treatment minus baseline. This averaged 69 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Zolpidem Escitalopram Placebo
Hide Arm/Group Description:
Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
Participants receiving an antidepressant, escitalopram
Participants receiving a placebo
Overall Number of Participants Analyzed 23 21 19
Mean (Standard Deviation)
Unit of Measure: diff score of diary Sleep Efficiency
3.20  (11.62) 0.61  (11.65) 4.87  (11.26)
3.Secondary Outcome
Title Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint
Hide Description 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.
Time Frame post treatment minus baseline PSG sleep studies. This averaged 70 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem Escitalpram Placebo
Hide Arm/Group Description:
Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
Participants receiving an antidepressant, escitalopram
Participants receiving a placebo
Overall Number of Participants Analyzed 17 19 19
Mean (Standard Deviation)
Unit of Measure: difference score for SE
0.43  (6.23) 1.16  (12.94) 0.32  (10.50)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Escitalopram Placebo
Hide Arm/Group Description Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem Participants receiving an antidepressant, escitalopram Participants receiving a placebo
All-Cause Mortality
Zolpidem Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/23 (0.00%)      1/20 (5.00%)    
Vascular disorders       
Inpatient Hospitalization  [1]  0/26 (0.00%)  0 0/23 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
Participant reported a hospitalization for hypertension
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      2/23 (8.70%)      0/20 (0.00%)    
Eye disorders       
Collodian remover splashed in eye * [1]  0/26 (0.00%)  0 1/23 (4.35%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin irritation related to EEG electrode placement * [2]  0/26 (0.00%)  0 1/23 (4.35%)  1 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
During electrode removal, the collodian remover splashed into one of the participant's eyes.
[2]
Participant reported some skin irritation at the site of electrode placement.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jean Miewald
Organization: University of Pittsburgh
Phone: 412-246-6406
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177216     History of Changes
Other Study ID Numbers: R01MH024652 ( U.S. NIH Grant/Contract )
R01MH024652 ( U.S. NIH Grant/Contract )
010807 ( Other Identifier: University of Pittsburgh Institutional Review Board )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: May 26, 2009
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016