| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Insomnia - Major Depressive Disorder |
| Purpose: |
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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.
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| Study summary: |
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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 enhances suicide risk for countless individuals
worldwide. A substantial proportion of MDD patients present with comorbid insomnia that
significantly complicates their clinical management. For many such patients, insomnia
represents a longstanding and problematic condition that predates the onset of MDD, adds to
their suicide risk, dampens their response to traditional depression treatment, and enhances
the likelihood for MDD relapse. Moreover, many patients who show remission of depressive
symptoms with traditional therapies (e.g., antidepressant medications, cognitive therapy)
suffer from residual insomnia that increases their chances for eventual relapse. Despite the
deleterious effects insomnia may have on MDD patients, there has been surprisingly little
research to test effective insomnia management strategies among this patient group. Some
reports suggest that depression treatments may benefit from adding a hypnotic medication to
traditional depression therapy, but this approach has it limits since sleep improvements
achieved with hypnotics do not endure after hypnotic discontinuation. Cognitive-Behavioral
Insomnia Therapy (CBT-I) represents a promising alternative treatment for MDD since it is
highly effective and produces sleep improvements that persist well beyond the
discontinuation of acute therapy. Unfortunately CBT-I has yet to be tested among MDD
patients with comorbid insomnia. In the current project, we will conduct a randomized
clinical trial to test the efficacy of CBT-I when used in isolation or in combination with
antidepressant medication (escitalopram) among MDD patients with comorbid insomnia. A
sample of 201 patients with MDD and comorbid insomnia will be randomized to treatments
consisting of the combination of antidepressant medication plus CBT-I, antidepressant
medication plus placebo behavioral insomnia therapy, or CBT-I plus a placebo medication.
Objective (polysomnography, actigraph) and subjective (sleep diary, questionnaires) sleep
measures, as well as depression and quality of life measures will be obtained before
therapy, after an 8-week treatment phase, and at 6-months follow-up. Results of this trial
will provide important new information about the short and long-term management of those
highly challenging and difficult to treat patients with insomnia comorbid to MDD.
Hypothesis I asserts that the combined CBT-I+AD therapy will produce significantly greater
pre-to-post therapy improvements in sleep continuity measures than will the 2 mono-therapy
conditions. The primary outcomes for these hypotheses are subjective (sleep diary) measures
of TWT and SE. These sleep measures are recorded daily for 2-week periods at baseline,
post-treatment, and the 6-month follow-up. The daily measures will be averaged over each
2-week period. As a result, patients will have three repeated outcomes for each of the two
sleep measures: one representing the average at baseline, one for the average at
post-treatment, and one for the average at 6-months. Sleep diary estimates of TWT and SE
from pre to post treatment will serve as the primary measures to test this hypothesis. Our
secondary outcome measures include diary estimates of total sleep time (TST), as well as
objective measures of TWT, SE, & TST taken from pre-and post-treatment PSG and actigraphic
monitoring We will use a 3 (treatment groups) x 2 (Baseline vs. post-treatment) Analysis of
Variance (ANOVA) model to compare the performance of our treatment conditions across the
primary and secondary outcomes. Treatment comparisons of CBT-I + AD vs. each of the other 2
treatments will be made. Alpha for the 2 primary outcomes is fixed at 0.025 (= 0.05/2).
Further analyses will adjust for pre-treatment stratification variables and other
covariates. We will, in particular, be mindful of the treatment adherence and credibility
data we collect and use these measures as covariates if we find differential adherence or
credibility rates across treatment conditions. In addition, we will explore the effect of
changes in medication on the observed changes in our outcome measures by considering
medication usage data derived from the MQS106. |
| Criteria: |
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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). |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Colleen Carney, PhD
Email: colleen.carney@duke.edu
Phone: 919-681-8730
Secondary Contact:
Colleen Carney, PhD.
Email: colleen.carney@duke.edu
Phone: 919681-8788 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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