Trial Outcomes & Findings for Circadian Effects of Escitalopram (NCT NCT01214044)
NCT ID: NCT01214044
Last Updated: 2019-08-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)
Results posted on
2019-08-20
Participant Flow
Participant milestones
| Measure |
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 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.
|
|---|---|
|
Visit 1: Screening and Consent, Washout
STARTED
|
31
|
|
Visit 1: Screening and Consent, Washout
COMPLETED
|
19
|
|
Visit 1: Screening and Consent, Washout
NOT COMPLETED
|
12
|
|
Visit 2: End Washout & Start Placebo
STARTED
|
19
|
|
Visit 2: End Washout & Start Placebo
COMPLETED
|
17
|
|
Visit 2: End Washout & Start Placebo
NOT COMPLETED
|
2
|
|
Visits 3-5: Escitalopram 10 mg Daily
STARTED
|
17
|
|
Visits 3-5: Escitalopram 10 mg Daily
COMPLETED
|
14
|
|
Visits 3-5: Escitalopram 10 mg Daily
NOT COMPLETED
|
3
|
|
Visits 6-11: Escitalopram 20 mg Daily
STARTED
|
14
|
|
Visits 6-11: Escitalopram 20 mg Daily
COMPLETED
|
10
|
|
Visits 6-11: Escitalopram 20 mg Daily
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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 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.
|
|---|---|
|
Visit 1: Screening and Consent, Washout
Withdrawal by Subject
|
5
|
|
Visit 1: Screening and Consent, Washout
Ineligible
|
3
|
|
Visit 1: Screening and Consent, Washout
Lost to Follow-up
|
4
|
|
Visits 3-5: Escitalopram 10 mg Daily
Withdrawal by Subject
|
3
|
|
Visits 6-11: Escitalopram 20 mg Daily
Withdrawal by Subject
|
3
|
|
Visits 6-11: Escitalopram 20 mg Daily
Adverse Event
|
1
|
Baseline Characteristics
Circadian Effects of Escitalopram
Baseline characteristics by cohort
| Measure |
Study Drug
n=10 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)Population: 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.
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).
Outcome measures
| Measure |
Study Drug
n=9 Participants
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.
|
|---|---|
|
Change in Dim Light Melatonin Onset
Baseline DLMO
|
21.17 decimal military time (hours)
Standard Deviation 1.24
|
|
Change in Dim Light Melatonin Onset
Post-escitalopram DLMO
|
20.77 decimal military time (hours)
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)Population: 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.
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.
Outcome measures
| Measure |
Study Drug
n=7 Participants
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.
|
|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D) Scores
|
-2.3 units on scale (scores)
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)Population: 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.
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.
Outcome measures
| Measure |
Study Drug
n=7 Participants
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.
|
|---|---|
|
Change in Beck Depression Inventory II (BDI-II) Scores
|
-3.3 units on scale (scores)
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)Population: 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.
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.
Outcome measures
| Measure |
Study Drug
n=7 Participants
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.
|
|---|---|
|
Change in Phase Angle Difference (PAD)
|
-0.6 hours
Standard Deviation 0.8
|
Adverse Events
Visit 1: Screening & Consent, Washout
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visit 2: End Washout & Start Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visits 3-5: Escitalopram 10 mg Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Visits 6-11: Escitalopram 20 mg Daily
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Visit 1: Screening & Consent, Washout
n=31 participants at risk
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.
|
Visit 2: End Washout & Start Placebo
n=19 participants at risk
After completing the washout period, Subjects will then complete a one week, single-blind placebo lead in phase.
|
Visits 3-5: Escitalopram 10 mg Daily
n=17 participants at risk
After the week of placebo, Subjects will then receive 10 mg/day of escitalpram for the first 2 weeks of active treatment.
|
Visits 6-11: Escitalopram 20 mg Daily
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/31 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/17 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Visit 1: Screening & Consent, Washout
n=31 participants at risk
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.
|
Visit 2: End Washout & Start Placebo
n=19 participants at risk
After completing the washout period, Subjects will then complete a one week, single-blind placebo lead in phase.
|
Visits 3-5: Escitalopram 10 mg Daily
n=17 participants at risk
After the week of placebo, Subjects will then receive 10 mg/day of escitalpram for the first 2 weeks of active treatment.
|
Visits 6-11: Escitalopram 20 mg Daily
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/31 • 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.
|
0.00%
0/19 • 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.
|
5.9%
1/17 • Number of events 1 • 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.
|
0.00%
0/14 • 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.
|
Additional Information
Jonathan Emens, M.D.
Oregon Health & Science University and VA Portland Health Care System
Phone: 503-220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place