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Trial record 11 of 16 for:    ZOLPIDEM AND Chronic Insomnia

Sequenced Therapies for Comorbid and Primary Insomnias

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ClinicalTrials.gov Identifier: NCT01651442
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : August 27, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jack Edinger, PhD, National Jewish Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Insomnia Comorbid to Psychiatric Disorder
Primary Insomnia
Interventions Behavioral: Behavioral Insomnia Therapy
Drug: Zolpidem
Drug: Trazodone
Behavioral: Cognitive Therapy
Enrollment 211
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-drug Sleep Therapy 1 Sleep Medication 1 Non-drug Sleep Therapy 2 Following Non-drug Sleep Therapy 1 Sleep Medication 2 Following Sleep Medication 1 Non-drug Sleep Therapy 1 Following Sleep Medication 1 Sleep Medication 1 Following Non-drug Sleep Therapy 1
Hide Arm/Group Description Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions. Zolpidem: 5mg or 10mg Cognitive Therapy: Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions. Trazodone: 50mg to 150mg Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions. Zolpidem: 5mg or 10mg
Period Title: Phase I Treatment
Started 104 107 0 0 0 0
Completed 88 80 0 0 0 0
Not Completed 16 27 0 0 0 0
Period Title: Phase II Treatment
Started 0 0 27 27 27 27
Completed 0 0 25 15 21 17
Not Completed 0 0 2 12 6 10
Arm/Group Title Non-drug Sleep Therapy 1 Sleep Medication 1 Total
Hide Arm/Group Description Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions. Zolpidem: 5mg or 10mg Total of all reporting groups
Overall Number of Baseline Participants 104 107 211
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 107 participants 211 participants
45.9  (14.4) 45.4  (15.5) 45.6  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 107 participants 211 participants
Female
64
  61.5%
68
  63.6%
132
  62.6%
Male
40
  38.5%
39
  36.4%
79
  37.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 107 participants 211 participants
White
94
  90.4%
93
  86.9%
187
  88.6%
Black
6
   5.8%
8
   7.5%
14
   6.6%
Other
3
   2.9%
3
   2.8%
6
   2.8%
Hispanic
4
   3.8%
8
   7.5%
12
   5.7%
1.Primary Outcome
Title Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index
Hide Description The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8.
Time Frame 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-drug Sleep Therapy 1 Sleep Medication 1 Sleep Medication 1 Plus Non-drug Sleep Therapy 1 Sleep Medication 1 Plus Sleep Medication 2 Non-drug Sleep Therapy 1 Plus Non-drug Sleep Therapy 1 Non-drug Sleep Therapy 1 Plus Sleep Medication 1
Hide Arm/Group Description:
Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
Zolpidem: 5mg or 10mg
Zolpidem Plus Behavioral Therapy
Zolpidem Plus Trazodone
Behavioral Therapy Plus Cognitive Therapy
Behavioral Therapy Plus Zolpidem
Overall Number of Participants Analyzed 90 83 27 27 27 27
Measure Type: Number
Unit of Measure: percent remitted
40.00 34.94 37.04 48.15 44.44 55.56
Time Frame Adverse event data were collected during the period from March 1, 2012 to July 1, 2017. Adverse Events were monitored in participants during the entirety of their participation, up to approximately 17 months for each participant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-drug Sleep Therapy 1 Sleep Medication 1 Non-drug Sleep Therapy 2 Sleep Medication 2
Hide Arm/Group Description Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions. Zolpidem: 5mg or 10mg Cognitive Therapy: Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions. Trazodone: 50mg to 150mg
All-Cause Mortality
Non-drug Sleep Therapy 1 Sleep Medication 1 Non-drug Sleep Therapy 2 Sleep Medication 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/134 (0.00%)   0/27 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-drug Sleep Therapy 1 Sleep Medication 1 Non-drug Sleep Therapy 2 Sleep Medication 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/134 (0.00%)   0/27 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-drug Sleep Therapy 1 Sleep Medication 1 Non-drug Sleep Therapy 2 Sleep Medication 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/134 (0.00%)   0/27 (0.00%)   0/27 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Bryan Simmons
Organization: National Jewish Health
Phone: 303-398-1850
EMail: simmonsb@njhealth.org
Layout table for additonal information
Responsible Party: Jack Edinger, PhD, National Jewish Health
ClinicalTrials.gov Identifier: NCT01651442     History of Changes
Other Study ID Numbers: R01MH091053-01 ( U.S. NIH Grant/Contract )
R01MH091075 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2012
First Posted: July 27, 2012
Results First Submitted: May 31, 2019
Results First Posted: August 27, 2019
Last Update Posted: August 27, 2019