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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149825
First Posted: September 8, 2005
Last Update Posted: May 20, 2014
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rachel Manber, Stanford University
September 6, 2005
September 8, 2005
July 30, 2009
October 14, 2009
May 20, 2014
June 2004
August 2007   (Final data collection date for primary outcome measure)
Remission of Depression (%) [ Time Frame: After 12 weeks or at the last available time point ]

Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.

The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.

The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).

Depression severity, at Week 12, Month 6
Complete list of historical versions of study NCT00149825 on ClinicalTrials.gov Archive Site
Remission of Insomnia [ Time Frame: After 12 weeks or at the last available time point ]
Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.
Insomnia severity, at Week 12, Month 6
Not Provided
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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Not Provided
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Insomnia
  • Drug: Escitalopram
    5 to 20 mg for 12 weeks
    Other Names:
    • Escitalopram plus Cognitive behavioral Therapy
    • Escitalopram plus Pseudo-desensitization Therapy
  • Behavioral: CBTI
    Cognitive Behavioral Treatment for Insomnia
    Other Name: Cognitive Behavioral Treatment for Insomnia
  • Behavioral: CTRL
    Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
    Other Name: Pseudo-desensitization Therapy for Insomnia
  • Experimental: MED+CBTI
    Escitalopram plus Cognitive Behavioral Therapy for Insomnia
    Interventions:
    • Drug: Escitalopram
    • Behavioral: CBTI
  • Active Comparator: MED+CTRL
    Escitalopram plus Pseudo-desensitization Therapy for Insomnia
    Interventions:
    • Drug: Escitalopram
    • Behavioral: CTRL

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2007
August 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • HRSD(17) score of at least 14
  • Presence and complaint of insomnia for at least 1 month
  • Fluent in English
  • Use of an effective form of contraception throughout the study

Exclusion Criteria:

  • Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
  • Psychotic symptoms
  • Serious, unstable, or terminal medical condition
  • Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
  • Substance abuse
  • Not willing to end other psychiatric treatment
  • Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
  • Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
  • Other sleep disorders
  • Currently pregnant or breastfeeding
  • History of seizure disorder
  • Disease or condition that produces altered metabolism or hemodynamic responses
  • Liver or kidney dysfunction
  • Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00149825
R21MH066131( U.S. NIH Grant/Contract )
R21MH066131 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
Not Provided
Not Provided
Not Provided
Rachel Manber, Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: Rachel Manber, PhD Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
Stanford University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP