Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

NCT00149825 | Completed Phase 2 Results

• 2 other identifiers: R21MH066131DSIR 83-ATAS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Insomnia

Keywords

Major Depressive Disorder; Insomnia; Sleep; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Remission of Insomnia

  After 12 weeks or at the last available time point

Study Arms (2)

MED+CBTI

EXPERIMENTAL

Escitalopram plus Cognitive Behavioral Therapy for Insomnia

Drug: Escitalopram; Behavioral: CBTI

MED+CTRL

ACTIVE COMPARATOR

Escitalopram plus Pseudo-desensitization Therapy for Insomnia

Drug: Escitalopram; Behavioral: CTRL

Interventions

Escitalopram DRUG

5 to 20 mg for 12 weeks

Also known as: Escitalopram plus Cognitive behavioral Therapy, Escitalopram plus Pseudo-desensitization Therapy

MED+CBTI; MED+CTRL

CBTI BEHAVIORAL

Cognitive Behavioral Treatment for Insomnia

Also known as: Cognitive Behavioral Treatment for Insomnia

MED+CBTI

CTRL BEHAVIORAL

Control Therapy consists of Pseudo-desensitization Therapy for Insomnia

Also known as: Pseudo-desensitization Therapy for Insomnia

MED+CTRL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 19616140 BACKGROUND

• 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. doi: 10.1093/sleep/31.4.489.

  PMID: 18457236 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Interventions

Escitalopram; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations of the current pilot study include a small sample size, relative racial homogeneity, and exclusion of patients with comorbidity.

Results Point of Contact

• Title: Rachel Manber, PhD
• Organization: Stanford University, School of Medicine

Rmanber@stanford.edu

650-724-2377

Study Officials

• Rachel Manber, PhD

  Stanford University Medical School, Department of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rachel Manber

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: June 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: May 20, 2014
• Results First Posted: October 14, 2009

Record last verified: 2014-05

Locations

US (1)