Circadian Effects of Escitalopram

NCT01214044 | Completed Results DMC

• 1 other identifier: LXP-MD-132
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in Dim Light Melatonin Onset

  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).

  8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Secondary Outcomes (3)

• Change in Hamilton Depression Rating Scale (HAM-D) Scores

  8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

• Change in Beck Depression Inventory II (BDI-II) Scores

  8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

• Change in Phase Angle Difference (PAD)

  8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Study Arms (1)

Study Drug

EXPERIMENTAL

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.

Drug: placebo/escitalopram

Interventions

placebo/escitalopram DRUG

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.

Also known as: Lexapro, escitalopram

Study Drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The sample size was small because this was a preliminary study that aimed to collect pilot data.

Results Point of Contact

• Title: Jonathan Emens, M.D.
• Organization: Oregon Health & Science University and VA Portland Health Care System

emensj@ohsu.edu

503-220-8262

Study Officials

• Jonathan Emens, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 20, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-08

Locations

US (1)