Child Behavior Disorders |
Bullying |
Clinical Trial: Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Depressive Disorder Sleep Initiation and Maintenance Disorders | Drug: Escitalopram Oxalate Behavior: Desensitization Therapy for Insomnia Behavior: Cognitive Behavioral Therapy for Insomnia | Phase I |
MedlinePlus related topics: Mental Health; Sleep Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: Insomnia severity, at Week 12, Month 6
Expected Total Enrollment: 58
Study start: October 2003
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
Inclusion Criteria:
- 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)
Location and Contact Information
California
Stanford University, Palo Alto, California, 94304, United States; Recruiting
Rachel Manber, PhD, Principal Investigator
Tracy F Kuo, PhD, Sub-Investigator
Jed Black, MD, Sub-Investigator
Rachel Manber, PhD, Principal Investigator, Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
More Information
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149825
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13

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