Circadian Effects of Escitalopram

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01214044
First received: October 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 1, 2010
October 1, 2010
May 2008
May 2011   (final data collection date for primary outcome measure)
Resetting effect of Escitalopram on the circadian pacemaker [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
To determine whether the antidepressant medication Escitalopram has a resetting effect on the human biological clock (circadian pacemaker).
Same as current
No Changes Posted
Correlation between improvement in depression with Escitalopram and the degree of realignment between the timing of sleep and the timing of the biological clock. [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
To demonstrate that there is a correlation between improvement in symptoms of depression with Escitalopram and the degree of realignment between the timing of sleep and the timing of the biological clock (circadian pacemaker).
Same as current
Not Provided
Not Provided
 
Circadian Effects of Escitalopram
Circadian Effects of Escitalopram

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.

Background: The human biological clock (circadian pacemaker) has long been thought to play a role in non-seasonal depression. A connection is suggested by the demonstration of 24-hour rhythms in mood, subjective and objective changes in sleep with depression, and reports of changes in the timing and amplitude of biological rhythms in depression. Furthermore, it is known that the neurotransmitter serotonin has a significant role in regulating biological rhythms and that drugs that act on serotonin (such as some antidepressants) are able to reset the biological clock in animals.

Objective: The aim of the study is to obtain preliminary data that will test whether the antidepressant medication escitalopram has a resetting effect on the human biological clock and whether the improvement in depression symptoms with escitalopram correlates with the degree to which the timing of the biological clock is realigned with the timing of sleep.

Design: 14-16-week, fixed dose (after titration), open label trial.

Setting and Subjects: 50 individuals will be screened for participation. 15 individuals with unipolar, non-seasonal depression will be studied over 1 year.

Intervention: Subjects will first complete a one week, single-blind placebo lead-in phase. Subjects will then receive escitalopram for 8 weeks (10 mg/day for the first 2 weeks of treatment and then 20mg/day for the remaining 6 weeks of treatment).

Measurements: Subjects will keep a sleep diary and wear a wrist activity monitor throughout the study to document the timing and quality of sleep. On two occasions (end of placebo week and end of last treatment week) blood and/or saliva will be sampled every 30 minutes for 7 hours and the resulting samples will be assayed for melatonin. The onset of melatonin secretion (dim light melatonin onset or DLMO) will be used to mark the timing of the biological clock (circadian phase). Circadian misalignment will be measured using the time interval between the DLMO and the average midsleep of the prior week (phase angle difference or PAD). Mood will be assessed throughout the study using the Hamilton Depression Rating Scale (HAM-D) as well as the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Depression
Drug: placebo/escitalopram
Subjects 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.
Other Names:
  • Lexapro
  • escitalopram
Experimental: Study Drug
Subjects 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.
Intervention: Drug: placebo/escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years old
  • able to comply with requirements of the experimental protocol
  • competent to sign informed consent
  • have mild to severe major depressive disorder without psychotic features and without a seasonal pattern
  • currently be under the care of a licensed mental health care provider or primary care physician
  • Score > 7 when interviewed by a trained rater using the 21-Item Hamilton Depression Scale (HAM-D)
  • be in good physical health
  • not be suicidal
  • not be taking any other antidepressant medications besides escitalopram during the study
  • be free of antidepressant medications for 2-4 weeks prior to beginning the study
  • not have a history of transmeridian travel or shift work in the past 2 months and have no plans for transmeridian travel or shift work for the duration of the study
  • be able to maintain a regular sleep wake schedule for the weeks one and nine of study
  • women of childbearing potential must have a negative pregnancy test and practice an acceptable method of birth control

Exclusion Criteria:

  • abnormal heart, liver, or kidney function
  • significant laboratory abnormalities on CBC, Complete Metabolic Set, TSH, EKG, & urinalysis
  • shift work or transmeridian travel in the last 2 months
  • current use of melatonin
  • evidence of a primary sleep disorder by history
  • women who are pregnant or lactating
  • be taking medications with known sedative or stimulating effects or that would interfere with the production of melatonin
Both
18 Years to 65 Years
No
United States
 
NCT01214044
LXP-MD-132
Yes
Jonathan Emens, MD, Oregon Health & Science University
Oregon Health and Science University
Forest Laboratories
Principal Investigator: Jonathan Emens, MD Oregon Health and Science University
Oregon Health and Science University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP