Behavioral Insomnia Therapy For Those With Insomnia and Depression

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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 patients with Major depressive disorder and insomnia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ryerson University
• Treatments: Antidepressive Agents; Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).