Trial Outcomes & Findings for L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults (NCT NCT03761030)
NCT ID: NCT03761030
Last Updated: 2023-05-22
Results Overview
The Hamilton Rating Scale for Depression (HRSD) is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
Change from Baseline to 8 Weeks
Results posted on
2023-05-22
Participant Flow
In total, 51 subjects were enrolled. Of the 51 enrolled, 20 subjects were found to be ineligible or did not continue in the study after enrolling. Thus, 51 participants enrolled and 31 were assigned to a treatment group and began the study.
Participant milestones
| Measure |
L-DOPA Arm
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults
Baseline characteristics by cohort
| Measure |
L-DOPA Arm
n=15 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=16 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Hamilton Rating Scale for Depression (24 item)
|
21.1 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
20.3 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
20.7 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Clinical Global Impressions--Severity
|
3.7 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with Week 8 data available were analyzed.
The Hamilton Rating Scale for Depression (HRSD) is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=12 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=13 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks)
|
-2.2 units on a scale
Standard Deviation 6.4
|
-3.6 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with Week 8 data available were analyzed.
The Digit Symbol test is a neuropsychological test measuring information processing speed. It consists of digit-symbol pairs (e.g. 1/-,2/┴ ... 7/Λ,8/X,9/=) followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured. Score ranges from 0-133, with higher scores indicating higher information processing speed. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=9 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=10 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Digit Symbol Test
|
2.8 Number of items correctly completed
Standard Deviation 4.0
|
5.0 Number of items correctly completed
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with Week 8 data available were analyzed
Patients' gait was assessed as walking speed in cm/s on a 15' walking course. Patients walked at their usual or normal speed for a total of 27' (starting and ending at a point 6 feet prior to and after the 15' course to eliminate acceleration and deceleration effects). Two trials were completed, and gait speed was based on the average of 2 trials. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=10 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=9 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Single Task Gait Speed
|
3.7 cm/s
Standard Deviation 14.9
|
-3.8 cm/s
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with available Week 8 data were analyzed
The Inventory of Depressive Symptomatology--Self Report (IDS-SR) is a rating scale for depressive symptoms based on standard diagnostic criteria for Major Depressive Disorder. The scale ranges from 0-84 with higher scores indicating more severe depression. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=10 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=10 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Inventory of Depressive Symptomatology--Self Report (IDS-SR)
|
-9.8 units on a scale
Standard Deviation 7.1
|
-12.1 units on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with available Week 8 data were analyzed
This test required participants to identify whether two visual patterns are the "same" or "not the same" (responses were made by pressing a "yes" or "no" button). Patterns were either identical or varied on one of three dimensions: color (all ages), adding/taking something away (all ages), or one versus many. Scores reflect the number of correct items completed in 90 s, with scores ranging from a minimum of 0 to a maximum of 30. Items were designed to minimize the number of errors that were made. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=11 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=10 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Pattern Comparison Test
|
0.6 Number of items correctly completed
Standard Deviation 2.1
|
1.2 Number of items correctly completed
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Change from Baseline to 8 WeeksPopulation: Participants with available Week 8 data were analyzed
Subjects were asked to determine whether two strings of letters are the same or different. There are 3 pages and the subject is given 30 seconds per page. Scoring is based on the number answered correctly. Scores range from 0 to 21, with the higher the number, the better the score. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Outcome measures
| Measure |
L-DOPA Arm
n=11 Participants
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=10 Participants
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Letter Comparison Test
|
1.2 Number of items correctly completed
Standard Deviation 1.6
|
0.7 Number of items correctly completed
Standard Deviation 1.4
|
Adverse Events
L-DOPA Arm
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 2 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
L-DOPA Arm
n=15 participants at risk
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=16 participants at risk
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Infections and infestations
Hospitalization for infection
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Death by suicide
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
Other adverse events
| Measure |
L-DOPA Arm
n=15 participants at risk
Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose
L-DOPA: We will be using generic sinemet 25/100 tablets in this study.
|
Placebo Arm
n=16 participants at risk
Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.
Placebo Oral Tablet: 25/100 placebo tablets
|
|---|---|---|
|
Eye disorders
Blurred vision
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 8 • Subjects were monitored over a period of 8 weeks.
|
18.8%
3/16 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
5/15 • Number of events 5 • Subjects were monitored over a period of 8 weeks.
|
25.0%
4/16 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Stomach/throat discomfort
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Increased appetite
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Weight loss
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
25.0%
4/16 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
General disorders
Hot flashes
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
General disorders
Malaise/weakness
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
|
General disorders
Poor balance
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Nervous system disorders
Incidental MRI finding
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Anxiety during neuroimaging
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
|
General disorders
Fall
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Toe fracture
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck/back pain
|
33.3%
5/15 • Number of events 6 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint/limb pain
|
26.7%
4/15 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Leg/ankle swelling
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness/rigidity
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
18.8%
3/16 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
|
31.2%
5/16 • Number of events 5 • Subjects were monitored over a period of 8 weeks.
|
|
Nervous system disorders
Numbness
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Nervous system disorders
Word finding difficulty
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Insomnia
|
40.0%
6/15 • Number of events 7 • Subjects were monitored over a period of 8 weeks.
|
37.5%
6/16 • Number of events 7 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Drowsiness
|
33.3%
5/15 • Number of events 6 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Excitement
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Vivid dreams
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
18.8%
3/16 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Irritability
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Forgetfulness
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Psychiatric disorders
Panic
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Renal and urinary disorders
Increased urination
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Renal and urinary disorders
Cloudy urine
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sighing
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Increased sweating
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Vascular disorders
Dizziness
|
40.0%
6/15 • Number of events 6 • Subjects were monitored over a period of 8 weeks.
|
25.0%
4/16 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
|
|
Vascular disorders
Increased heart rate
|
13.3%
2/15 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Vascular disorders
Decreased heart rate
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
6.2%
1/16 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
|
Vascular disorders
Abnormal heart rhythm
|
6.7%
1/15 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
|
0.00%
0/16 • Subjects were monitored over a period of 8 weeks.
|
|
Vascular disorders
Palpitations
|
0.00%
0/15 • Subjects were monitored over a period of 8 weeks.
|
12.5%
2/16 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
|
Additional Information
Dr. Bret Rutherford
New York State Psychiatric Institute
Phone: 646 774 8660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place