Clinical trial NCT00149825: Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Insomnia
Keywords: Major Depressive Disorder
Insomnia
Sleep
Mental Health
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Remission of Depression (%)
timeFrame: After 12 weeks or at the last available time point
Secondary outcomes:
measure: Remission of Insomnia
timeFrame: After 12 weeks or at the last available time point
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
name: Rachel Manber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25.
citation: Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. doi: 10.1093/sleep/31.4.489.