Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Completed · Phase 2
Conditions studied: Major Depressive Disorder, Insomnia
In brief
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Key facts
- Study ID
- NCT00149825
- Run by
- Stanford University
- People needed
- 30
- Starts
- 2004-06-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Stanford University — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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