Depression | Circadian Effects of Escitalopram
Depression research study
What is the primary objective of this study?
The goal of the study is to obtain preliminary data that will test whether the antidepressant medication escitalopram resets the body clock: a collection of nerve cells in the brain that control the timing of many body processes. The study will also test whether the improvement in depression symptoms with escitalopram correlates with the degree to which the timing of the body clock is properly aligned with the timing of sleep.
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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:placebo/escitalopramSubjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed on a weekly basis.
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.
Study DrugSubjects will have a total of 12 visits to OCTRI at OHSU over the 14-16 weeks of study. Subjects will first undergo an initial screening visit to determine eligibility. Subjects who meet criteria and agree to participate will then stop taking their current antidepressant medication (if applicable), during which time the study doctor and staff will conduct weekly mood assessments to ensure safety. Subjects will then have a study initiation/materials visit followed by 9 visits during treatment with placebo or escitalopram. A final post-study follow-up safety visit will be scheduled at the end of treatment.
Start Date: May 2008
Primary Outcome: Resetting effect of Escitalopram on the circadian pacemaker
Secondary Outcome: Correlation between improvement in depression with Escitalopram and the degree of realignment between the timing of sleep and the timing of the biological clock.
Study sponsors, principal investigator, and references
Principal Investigator: Jonathan Emens, MD
Lead Sponsor: Oregon Health and Science University
Collaborator: Forest Laboratories