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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome - Article


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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

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00149825

Purpose

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

Further Study Details: 
Primary Outcomes: Depression severity, at Week 12, Month 6
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

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00149825

Melanie G San Pedro-Salcedo, MA      650-724-9774    msanpedro@stanford.edu

California
      Stanford University, Palo Alto,  California,  94304,  United States; Recruiting
Melanie G San Pedro-Salcedo  650-724-9774    msanpedro@stanford.edu 
Rachel Manber, PhD,  Principal Investigator
Tracy F Kuo, PhD,  Sub-Investigator
Jed Black, MD,  Sub-Investigator

Study chairs or principal investigators

Rachel Manber, PhD,  Principal Investigator,  Stanford University Medical School, Department of Psychiatry and Behavioral Sciences   

More Information

Study ID Numbers:  66131-01A2
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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Page Updated: September 6, 2005
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