Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 467 for:    ESCITALOPRAM AND Cholinergic

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Depression
Intervention Drug: placebo/escitalopram
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Drug
Hide Arm/Group Description

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 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.

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.

Period Title: Visit 1: Screening and Consent, Washout
Started 31
Completed 19
Not Completed 12
Reason Not Completed
Withdrawal by Subject             5
Ineligible             3
Lost to Follow-up             4
Period Title: Visit 2: End Washout & Start Placebo
Started 19
Completed 17 [1]
Not Completed 2
[1]
2 subjects dropped out during the placebo week (between study visits 2 & 3)
Period Title: Visits 3-5: Escitalopram 10 mg Daily
Started 17
Completed 14
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Period Title: Visits 6-11: Escitalopram 20 mg Daily
Started 14
Completed 10
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Adverse Event             1
Arm/Group Title Study Drug
Hide Arm/Group Description

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. An initial screening visit will 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.

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 weekly.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
50.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change in Dim Light Melatonin Onset
Hide Description

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).

Time Frame 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 10 subjects who completed all study procedures, adequate dim light melatonin data from both study visits 3 and 11 were available for 9 subjects.
Arm/Group Title Study Drug
Hide Arm/Group Description:

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. An initial screening visit will 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.

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 weekly.

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: decimal military time (hours)
Baseline DLMO 21.17  (1.24)
Post-escitalopram DLMO 20.77  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Drug
Comments A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).
Type of Statistical Test Other
Comments A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.
Statistical Test of Hypothesis P-Value 0.2
Comments A priori threshold for significance was p = 0.05.
Method t-test, 2 sided
Comments paired t-test
2.Secondary Outcome
Title Change in Hamilton Depression Rating Scale (HAM-D) Scores
Hide Description 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.
Time Frame 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 10 subjects who completed all study procedures, adequate Hamilton Depression Rating Scale data from both study visits 3 and 11 were available for 7 subjects.
Arm/Group Title Study Drug
Hide Arm/Group Description:

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. An initial screening visit will 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.

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.

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on scale (scores)
-2.3  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Drug
Comments

We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.

A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).

Type of Statistical Test Other
Comments A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.
Statistical Test of Hypothesis P-Value 0.01
Comments A priori threshold for significance was p = 0.05.
Method t-test, 1 sided
Comments paired t-test
3.Secondary Outcome
Title Change in Beck Depression Inventory II (BDI-II) Scores
Hide Description 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.
Time Frame 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 10 subjects who completed all study procedures, Beck Depression Inventory-II data from both study visits 3 and 11 were available for 7 subjects.
Arm/Group Title Study Drug
Hide Arm/Group Description:

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. An initial screening visit will 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.

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.

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on scale (scores)
-3.3  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Drug
Comments

We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.

A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).

Type of Statistical Test Other
Comments A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.
Statistical Test of Hypothesis P-Value 0.14
Comments A priori threshold for significance was p = 0.05.
Method t-test, 1 sided
Comments paired t-test
4.Secondary Outcome
Title Change in Phase Angle Difference (PAD)
Hide Description 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.
Time Frame 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 10 subjects who completed all study procedures, adequate PAD data from both study visits 3 and 11 (derived from dim light melatonin onset and sleep diary) were available for 7 subjects.
Arm/Group Title Study Drug
Hide Arm/Group Description:

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. An initial screening visit will 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.

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.

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: hours
-0.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Drug
Comments We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.
Type of Statistical Test Other
Comments Spearman's rank-order correlation (non-parametric test) was used.
Statistical Test of Hypothesis P-Value 0.06
Comments Spearman's rho (rs) = 0.66
Method Spearman's rank-order correlation
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Drug
Comments We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.
Type of Statistical Test Other
Comments Spearman's rank-order correlation (non-parametric test) was used.
Statistical Test of Hypothesis P-Value 0.48
Comments Spearman's rho (rs) = 0.02
Method Spearman's rank-order correlation
Comments [Not Specified]
Time Frame Participants were assessed over 14 weeks (or 16 weeks in two subjects who were on fluoxetine at enrollment and therefore had a 4-week, instead of a 2-week, washout period per the protocol). Subjects had a weekly contact with study personnel throughout the 14 or 16 weeks of study except for the two week medication taper period between the last two study visits.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Visit 1: Screening & Consent, Washout Visit 2: End Washout & Start Placebo Visits 3-5: Escitalopram 10 mg Daily Visits 6-11: Escitalopram 20 mg Daily
Hide Arm/Group Description 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. An initial screening visit will 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. After completing the washout period, Subjects will then complete a one week, single-blind placebo lead in phase. After the week of placebo, Subjects will then receive 10 mg/day of escitalpram for the first 2 weeks of active treatment. After receiving 10 mg/day of escitalopram for 2 weeks, subjects will then receive escitalopram, 20 mg/day for the remaining 6 weeks of treatment.
All-Cause Mortality
Visit 1: Screening & Consent, Washout Visit 2: End Washout & Start Placebo Visits 3-5: Escitalopram 10 mg Daily Visits 6-11: Escitalopram 20 mg Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/19 (0.00%)      0/17 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Visit 1: Screening & Consent, Washout Visit 2: End Washout & Start Placebo Visits 3-5: Escitalopram 10 mg Daily Visits 6-11: Escitalopram 20 mg Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/19 (0.00%)      0/17 (0.00%)      1/14 (7.14%)    
Psychiatric disorders         
suicide attempt * [1]  0/31 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
[1]
In this cohort of subjects with mild to severe Major Depressive Disorder, one subject was admitted to an outside hospital following a suicide attempt and was subsequently transferred to outpatient facility for ongoing treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Visit 1: Screening & Consent, Washout Visit 2: End Washout & Start Placebo Visits 3-5: Escitalopram 10 mg Daily Visits 6-11: Escitalopram 20 mg Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/19 (0.00%)      1/17 (5.88%)      0/14 (0.00%)    
Nervous system disorders         
Headache * [1]  0/31 (0.00%)  0 0/19 (0.00%)  0 1/17 (5.88%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
One subject reported the onset of a headache around 6 pm with subsequent feelings of her heart racing, feeling flushed in her face & neck and some itchiness. The symptoms resolved after 2 hours.
The sample size was small because this was a preliminary study that aimed to collect pilot data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Emens, M.D.
Organization: Oregon Health & Science University and VA Portland Health Care System
Phone: 503-220-8262 ext 58490
EMail: emensj@ohsu.edu
Layout table for additonal information
Responsible Party: Jonathan Emens, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01214044     History of Changes
Other Study ID Numbers: LXP-MD-132
First Submitted: October 1, 2010
First Posted: October 4, 2010
Results First Submitted: November 28, 2018
Results First Posted: August 6, 2019
Last Update Posted: August 20, 2019