Chronic insomnia is among the most common symptoms during a major depressive episode (MDE), and the symptom of insomnia independently predicts poor quality of life (QOL), increased risk of suicide, and increased risk for recurrence of MDE. In contrast, preliminary evidence suggests that treatment of insomnia during MDE reduces the daytime symptom burden and improves QOL. Hypnotic medications (sleeping pills) are prescribed more commonly for psychiatric problems than for any other disorder, and this is not surprising since many of the newest antidepressants have little or no intrinsic sleep-inducing effect and may require that a hypnotic be prescribed along with the antidepressant. However, little is known about the efficacy and safety of combining the most commonly used antidepressant and hypnotic medications. This exploratory/development grant (R34 mechanism) will operationalize treatment of insomnia associated with MDE, will support the development of data-gathering methods for the proposed outcomes of interest, and shall test the feasibility of recruiting and retaining participants, and shall provide estimates of effect sizes for adding a hypnotic medication to an antidepressant in depressed patients with insomnia. Specifically, patients with MDE and insomnia who do respond to open fluoxetine monotherapy for 2 weeks are randomized to either placebo or the hypnotic zolpidem for 4 weeks, while continuing open fluoxetine. Participants shall be followed for an additional 4 months of naturalistic follow up after hypnotic/placebo therapy. Important outcome measures shall include reported and PSG sleep, mood, suicidal thinking, and QOL. We hypothesize that combined zolpidem and fluoxetine shall be associated with better QOL than receipt of fluoxetine and placebo. The projected effect sizes suggest that it is likely that statistically significant differences shall be found between groups that can be recruited during this exploratory/development grant. The application shall result in a proven methodology for examining the utility of hypnotic medications in depressed person with insomnia, and shall result in realistic sample size projections for a subsequent R01application that may include a three-armed comparison of placebo, versus hypnotic, versus sedating anti-depressant as add-on therapy for depression with insomnia.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Planning Grant (R34)
Project #
1R34MH070821-01A2
Application #
6983486
Study Section
Interventions Research Review Committee (ITV)
Program Officer
Rudorfer, Matthew V
Project Start
2005-09-01
Project End
2008-05-31
Budget Start
2005-09-01
Budget End
2006-05-31
Support Year
1
Fiscal Year
2005
Total Cost
$190,593
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Psychiatry
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
McCall, W Vaughn (2015) A rest-activity biomarker to predict response to SSRIs in major depressive disorder. J Psychiatr Res 64:19-22
McCall, Catherine; McCall, W Vaughn (2012) Objective vs. subjective measurements of sleep in depressed insomniacs: first night effect or reverse first night effect? J Clin Sleep Med 8:59-65
McCall, Catherine; McCall, W Vaughn (2012) Comparison of actigraphy with polysomnography and sleep logs in depressed insomniacs. J Sleep Res 21:122-7
McCall, W Vaughn; D'Agostino Jr, Ralph; Rosenquist, Peter B et al. (2011) Dissection of the factors driving the placebo effect in hypnotic treatment of depressed insomniacs. Sleep Med 12:557-64
McCall, W Vaughn; Blocker, Jill N; D'Agostino Jr, Ralph et al. (2010) Treatment of insomnia in depressed insomniacs: effects on health-related quality of life, objective and self-reported sleep, and depression. J Clin Sleep Med 6:322-9
McCall, W Vaughn; Blocker, Jill N; D'Agostino Jr, Ralph et al. (2010) Insomnia severity is an indicator of suicidal ideation during a depression clinical trial. Sleep Med 11:822-7
McCall, W Vaughn; Kimball, James; Boggs, Niki et al. (2009) Prevalence and prediction of primary sleep disorders in a clinical trial of depressed patients with insomnia. J Clin Sleep Med 5:454-8