Status:
UNKNOWN
Behavioral Insomnia Therapy For Those With Insomnia and Depression
Lead Sponsor:
Toronto Metropolitan University
Conditions:
Insomnia
Major Depressive Disorder
Eligibility:
All Genders
21-64 years
Phase:
NA
Brief Summary
This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among pat...
Detailed Description
Major depressive disorder (MDD) is a highly prevalent and debilitating condition that reduces quality of life, increases health care utilization, markedly impairs social/occupational functioning, and ...
Eligibility Criteria
Inclusion
- aged 21-64 years old
- insomnia complaint of at least one month duration that meets the Research Diagnostic Criteria for Insomnia
- meet DSM-IV criteria for a Major Depressive Episode (without psychotic features) as verified by the mood module of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID
Exclusion
- need immediate psychiatric (e.g., imminently suicidal patients) or medical care (e.g., patients with acute cardiac symptoms), or have attempted suicide in the past 6 months
- have a sleep-disruptive comorbid medical condition (e.g., moderate to severe rheumatoid arthritis
- are pregnant, trying to get pregnant, or not currently practicing adequate birth control methods
- score \< 27 on the Mini-Mental Status Exam
- meet DSM-IV criteria for Obsessive-Compulsive disorder, Generalized Anxiety Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder, Panic Disorder, Bipolar Disorder, Schizophrenia or any other psychotic disorders on the basis of a SCID interview
- meet DSM-IV criteria for Antisocial Personality Disorder or Borderline Personality Disorder on the basis of a SCID II interview schedule
- report frequent travel across time zones or work rotating or night shifts
- meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD)
- have an apnea-hypopnea index \> 15 or periodic limb movement-related arousal index \> 15 per hour of sleep during a screening laboratory polysomnogram
- have a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence in the 6 months prior to screening or have a positive urine drug or alcohol test at the time of screening
- report having taken the study drug (escitalopram) for 28 days or more and then discontinuing the medication due to side effects or adverse event
- have a disorder characterized by altered metabolism, a seizure disorder, severe renal impairment, a history of upper gastrointestinal bleed disorder, or a history of a condition that could interfere with the absorption, distribution, metabolism, or excretion of escitalopram
- participated in any other investigational drug study within 30 days prior to screening or become enrolled in another such study during the time they are enrolled in the current project
- use of any drugs known or suspected to affect hepatic or renal clearance within 30 days prior to screening for the current project
- are taking any medications that interact with escitalopram (e.g., Cimetidine, Lithium, Sumatriptan, Carbamazepine, or Ketoconazole) and are not willing to both taper off such medications during a time period equal to more than five half lives before entering the study and abstain from such medications throughout the study
- are unwilling or unable to abstain from non-study prescription medications for sleep (e.g., sedative hypnotics) or depression during their time in the study
- are known to be seropositive for Human Immunodeficiency Virus (HIV).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT00620789
Start Date
March 1 2008
End Date
January 1 2014
Last Update
May 31 2013
Active Locations (1)
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1
Ryerson University
Toronto, Ontario, Canada, M5B2K3