ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 2096 for:    Symptoms | Parasomnias

Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Experimental: Zolpidem   Experimental: Excitalopram   Placebo Comparator: Placebo
STARTED   26   23   20 
COMPLETED   20   20   19 
NOT COMPLETED   6   3   1 
Withdrawal by Subject                6                3                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Experimental: Zolpidem   Experimental: Excitalopram   Placebo Comparator: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   23   20   69 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   26   23   20   69 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.07  (9.07)   34.49  (9.34)   37.46  (8.63)   36.67  (9.05) 
Gender 
[Units: Participants]
       
Female   15   12   11   38 
Male   11   11   9   31 
Region of Enrollment 
[Units: Participants]
       
United States   26   23   20   69 


  Outcome Measures

1.  Primary:   Change in Pittsburgh Sleep Quality Index   [ Time Frame: post treatment minus baseline assessment battery. This averaged 100 days. ]

2.  Primary:   Change in Diary Sleep Efficiency   [ Time Frame: post treatment minus baseline. This averaged 69 days. ]

3.  Secondary:   Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint   [ Time Frame: post treatment minus baseline PSG sleep studies. This averaged 70 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: miewaldjm@upmc.edu



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