Status:
COMPLETED
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 resol...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00149825
Start Date
June 1 2004
End Date
August 1 2007
Last Update
May 20 2014
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304