Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome - Full Text View

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
Major Depressive Disorder Insomnia	Drug: Escitalopram Behavioral: CBTI Behavioral: CTRL	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Mental Health

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Remission of Depression (%) [ Time Frame: After 12 weeks or at the last available time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Remission of Insomnia [ Time Frame: After 12 weeks or at the last available time point ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	June 2004
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MED+CBTI Escitalopram plus Cognitive Behavioral Therapy for Insomnia	Drug: Escitalopram 5 to 20 mg for 12 weeks Other Names: Escitalopram plus Cognitive behavioral Therapy Escitalopram plus Pseudo-desensitization Therapy Behavioral: CBTI Cognitive Behavioral Treatment for Insomnia Other Name: Cognitive Behavioral Treatment for Insomnia
Active Comparator: MED+CTRL Escitalopram plus Pseudo-desensitization Therapy for Insomnia	Drug: Escitalopram 5 to 20 mg for 12 weeks Other Names: Escitalopram plus Cognitive behavioral Therapy Escitalopram plus Pseudo-desensitization Therapy Behavioral: CTRL Control Therapy consists of Pseudo-desensitization Therapy for Insomnia Other Name: Pseudo-desensitization Therapy for Insomnia

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149825

Locations

United States, California
Stanford University
Palo Alto, California, United States, 94304

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Rachel Manber, PhD

Stanford University Medical School, Department of Psychiatry and Behavioral Sciences

More Information

Additional Information:

Study Information Website This link exits the ClinicalTrials.gov site

Publications:

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 1;31(4):489-95.

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. Epub 2009 Apr 25.

Responsible Party:	Rachel Manber, PhD, Stanford University
ClinicalTrials.gov Identifier:	NCT00149825 History of Changes
Other Study ID Numbers:	R21 MH066131, DSIR 83-ATAS
Study First Received:	September 6, 2005
Results First Received:	July 30, 2009
Last Updated:	September 11, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major Depressive Disorder
Insomnia
Sleep
Mental Health

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 19, 2013