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Insomnia | Behavioral Insomnia Therapy For Those With Insomnia and Depression

Insomnia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Escitalopram + CBT-IEscitalopram, 10 mg daily for the duration of the study (6 months) CBT-I, four biweekly sessions during eight week Treatment phase.

Behavioral:CBT-I plus placebo antidepressant medicationCBT-I, 4 biweekly sessions, eight week Treatment phase. Placebo,daily for duration of study(6 months).

Drug:EscitalopramEscitalopram, 10 mg daily for the duration of the study (6 months) SH, four biweekly sessions during eight week Treatment phase

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Cognitive-Behavior Therapy for insomnia (CBT-I) + Antidepressant medication

2Cognitive Behavior Therapy for Insomnia (CBT-I) + placebo medication

3Antidepressant medication + Sleep Hygiene Control (SH)

Study Status

Unknown status

Start Date: March 2008

Completed Date: January 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Mean two-week sleep log estimate of post-treatment sleep continuity

Secondary Outcome: Mean two-night polysomnographic post-treatment sleep continuity

Study sponsors, principal investigator, and references

Principal Investigator: Colleen Carney, PhD

Lead Sponsor: Ryerson University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00620789

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