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Trial record 22 of 595 for:    ESCITALOPRAM

Circadian Effects of Escitalopram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01214044
Recruitment Status : Completed
First Posted : October 4, 2010
Results First Posted : August 6, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jonathan Emens, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE October 1, 2010
First Posted Date  ICMJE October 4, 2010
Results First Submitted Date  ICMJE November 28, 2018
Results First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
Change in Dim Light Melatonin Onset [ Time Frame: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram) ]
The Dim Light Melatonin Onset (DLMO) is the time of the onset of melatonin secretion under dim light conditions using the equivalent thresholds of 10 pg/ml in plasma and 3 pg/ml in saliva. It is a marker of biological time. Data are provided in decimal and military time (e.g., 9:30 pm equals 21.50). This measure is used to determine if there was a change in the time of the dim light melatonin onset (DLMO) before treatment with escitalopram (at Study Visit 3) and after treatment with escitalopram (at Study Visit 11).
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2010)
Resetting effect of Escitalopram on the circadian pacemaker [ Time Frame: 3-4 months ]
To determine whether the antidepressant medication Escitalopram has a resetting effect on the human biological clock (circadian pacemaker).
Change History Complete list of historical versions of study NCT01214044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Change in Hamilton Depression Rating Scale (HAM-D) Scores [ Time Frame: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram) ]
    The HAM-D is the total score on the 21-question Hamilton Depression Rating Scale. Scores range from 0 to 53 with higher scores indicating worse symptoms of depression.
  • Change in Beck Depression Inventory II (BDI-II) Scores [ Time Frame: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram) ]
    The BDI-II is the total score on the 21-question Beck Depression Inventory II questionnaire. Scores range from 0 to 63 with higher scores indicating worse symptoms of depression.
  • Change in Phase Angle Difference (PAD) [ Time Frame: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram) ]
    The PAD is the time interval (number of hours) between the Dim Light Melatonin Onset (DLMO) and the average midpoint of sleep during the prior week. Larger PADs indicate a longer time interval between the DLMO and midpoint of sleep. A negative change in PAD value indicates a shortening of the time interval from Study Visit 3 to Study Visit 11.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2010)
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 ]
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Circadian Effects of Escitalopram
Official Title  ICMJE Determination of the Circadian Resetting Effects of Escitalopram and Testing for Correlations Between Circadian Resetting and Antidepressant Effects
Brief Summary 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.
Detailed Description

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Study Drug
Subjects will have a total of 12 visits to Oregon Clinical & Translational Research Institute at Oregon Health & Science University 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2010)
15
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Complete Blood Count, Complete Metabolic Set, Thyroid Stimulating Hormone, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01214044
Other Study ID Numbers  ICMJE LXP-MD-132
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Emens, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Jonathan Emens, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date August 2019

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