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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00149825
First received: September 6, 2005
Last updated: September 11, 2009
Last verified: July 2009
History of Changes
Results First Received: July 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Insomnia
Interventions: Drug: Escitalopram
Behavioral: CBTI
Behavioral: CTRL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants were screened to determine if inclusion exclusion criteria were met. This process included structured clinical interviews, completion of sleep logs, and an ambulatory screening sleep study to rule out other sleep disorders.

Reporting Groups
  Description
MED+CBTI Escitalopram plus cognitive behavioral therapy for insomnia
MED+CTRL Escitalopram plus control therapy for insomnia in depression

Participant Flow:   Overall Study
    MED+CBTI     MED+CTRL  
STARTED     15     15  
COMPLETED     10     12  
NOT COMPLETED     5     3  
Intolerance to medication side effects                 1                 2  
Time commitments                 2                 1  
Not liking insomnia therapy                 1                 0  
Unknown                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
MED+CBTI Escitalopram plus cognitive behavioral therapy for insomnia
MED+CTRL Escitalopram plus control therapy for insomnia in depression
Total Total of all reporting groups

Baseline Measures
    MED+CBTI     MED+CTRL     Total  
Number of Participants  
[units: participants]
 		  15     15     30  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     14     13     27  
>=65 years     1     2     3  
Age  
[units: years]
Mean ± Standard Deviation 		  49.5  ± 13.6     47.8  ± 13.4     48.6  ± 13.3  
Gender  
[units: participants]
 		     
Female     9     10     19  
Male     6     5     11  
Region of Enrollment  
[units: participants]
 		     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Remission of Depression (%)   [ Time Frame: After 12 weeks or at the last available time point ]
  Show Outcome Measure 1

2.  Secondary:   Remission of Insomnia   [ Time Frame: After 12 weeks or at the last available time point ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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
Limitations of the current pilot study include a small sample size, relative racial homogeneity, and exclusion of patients with comorbidity.  


Results Point of Contact:  
Name/Title: Rachel Manber, PhD
Organization: Stanford University, School of Medicine
phone: 650-724-2377
e-mail: Rmanber@stanford.edu


Publications of Results:

Other Publications:


Responsible Party: Rachel Manber, PhD, Stanford University
ClinicalTrials.gov Identifier: NCT00149825     History of Changes
Other Study ID Numbers: R21 MH066131, DSIR 83-ATAS
Study First Received: September 6, 2005
Results First Received: July 30, 2009
Last Updated: September 11, 2009
Health Authority: United States: Federal Government