Behavioral Insomnia Therapy For Those With Insomnia and Depression

NCT00620789 | Unknown

• 2 other identifiers: Pro000034161R01MH076856-01A2
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

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 patients with Major depressive disorder and insomnia.

Conditions

Insomnia; Major Depressive Disorder

Keywords

Insomnia; Depression

Outcome Measures

Primary Outcomes (1)

• Mean two-week sleep log estimate of post-treatment sleep continuity

  Mean two-week post-treatment sleep log sleep continuity

  An average of two-weeks post-treatment

Secondary Outcomes (1)

• Mean two-night polysomnographic post-treatment sleep continuity

  An average of two-weeks post-treatment

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: Escitalopram + CBT-I

2

PLACEBO COMPARATOR

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

Behavioral: CBT-I plus placebo antidepressant medication

3

SHAM COMPARATOR

Antidepressant medication + Sleep Hygiene Control (SH)

Drug: Escitalopram

Interventions

Escitalopram + CBT-I DRUG

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

Also known as: Escitalopram,Lexipro, CBT-I, Cognitive Behavioral Therapy-Insomnia

1

CBT-I plus placebo antidepressant medication BEHAVIORAL

* CBT-I, 4 biweekly sessions, eight week Treatment phase. * Placebo,daily for duration of study(6 months).

Also known as: CBT-I, Cognitive Behavioral Therapy Insomnia

2

Escitalopram DRUG

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

Also known as: Escitalopram, Lexipro, SH,Sleep Hygiene

3

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B2K3, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Colleen Carney, PhD

  Licensed, North Carolina Psychology Board, Ontario Psychological Association, Association for Behavioral and Cognative Therapies, ABCT Insomnia and other Sleep Disorders Special Interest Group, Sleep Research Society, American Academy of Sleep Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Carney, PhD.

CONTACT

416-979-5000; ccarney@ryerson.ca

Olya Shuhatovich, MPH

CONTACT

416-979-5000; olya@ryerson.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Department of Psychology

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

CA (1)