Phase 2
N=30
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Major Depressive Disorder · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00149825 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Remission of Depression (%) — 61.5; 33.3 percent of participants — p=.13
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Escitalopram (Drug); CBTI (Behavioral); CTRL (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission of Depression (%) |
61.5; 33.3 | .13 |
| SECONDARY Remission of Insomnia |
50.0; 7.7 | .05 |
Summary
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
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)
Data sourced from ClinicalTrials.gov (NCT00149825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.