Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149825
• Other study ID #: R21MH066131
• Secondary ID: R21MH066131DSIR
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: May 12, 2014
• Start date: June 2004
• Est. completion date: August 2007

Study information

• Verified date: May 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insomnia
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
5 to 20 mg for 12 weeks

Behavioral:
• CBTI
Cognitive Behavioral Treatment for Insomnia
• CTRL
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. — View Citation

Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of Depression (%)	Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score = 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.; The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.; The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).	After 12 weeks or at the last available time point	No
Secondary	Remission of Insomnia	Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.	After 12 weeks or at the last available time point	No

External Links

•   Study Information Website