Trial Outcomes & Findings for A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise (NCT NCT02407704)
NCT ID: NCT02407704
Last Updated: 2018-05-23
Results Overview
Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12
Results posted on
2018-05-23
Participant Flow
Participants were diagnosed using the SCID, and were excluded from participation if they did not meet criteria for Major Depressive Disorder. Participants were also excluded for presence of bipolar or psychotic disorders, alcohol/substance dependence within the past 3 months, or if they could not complete MRI.
Participant milestones
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
5
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise
Baseline characteristics by cohort
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=5 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=5 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Montgomery Asberg Depression Rating Scale
|
27.00 units on a scale
STANDARD_DEVIATION 0.71 • n=5 Participants
|
24.33 units on a scale
STANDARD_DEVIATION 3.51 • n=7 Participants
|
21.80 units on a scale
STANDARD_DEVIATION 5.81 • n=5 Participants
|
25.60 units on a scale
STANDARD_DEVIATION 4.55 • n=4 Participants
|
23.73 units on a scale
STANDARD_DEVIATION 4.23 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12Population: 1 participant in the "Venlafaxine XR Only (20-39 Years of Age)" group was excluded from analyses as he/she discontinued the medication after week 8.
Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Remission
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksBlood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Inflammatory Biomarkers
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Genetic Biomarkers
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
NA Participants
Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication after Week 8.
This will be used to acquire objective information about physical activity. This armband is worn around the upper arm (left triceps) for 1 week and collects information about skin temperature, galvanic skin response, heat flux, and motion via a 3-axis accelerometer. This information is used in an algorithm to determine energy expenditure (EE). The device has a resolution of 1-minute indicating that we can acquire the above information on a minute-by-minute basis, which will allow us to determine both duration and intensity of activity during a normal week. Higher values indicate higher levels of activity.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Physical Activity (SenseWear Physical Activity-monitoring Armband)
12 Week Average Daily EE
|
324.03 kcals
Standard Deviation 352.57
|
212.48 kcals
Standard Deviation 216.95
|
694.21 kcals
Standard Deviation 455.45
|
905.36 kcals
Standard Deviation 596.69
|
|
Physical Activity (SenseWear Physical Activity-monitoring Armband)
Baseline Average Daily EE
|
911.04 kcals
Standard Deviation 604.31
|
201.64 kcals
Standard Deviation 149.47
|
422.70 kcals
Standard Deviation 694.21
|
731.06 kcals
Standard Deviation 905.36
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 1 participant in the "Venlafaxine XR Only (20-39 Years of Age)" group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication at Week 8.
Cardiorespiratory fitness was measured via submaximal VO2 on a motorized treadmill while measuring oxygen utilization via Parvo Medics True one metabolic cart. The submaximal test followed a modified Balke protocol in which speed remained constant with the intensity being increased every two minutes via a raise of 2.0% of the incline. The speed was an agreed upon speed between participant and staff (between 2.0 and 4.0 mph). The submaximal VO2 was stopped when participant reached 85% of age predicted maximal heart rate (220 - age), rating of perceived exertion (RPE) equal to or greater than 15 for those who have blunted heart rate response due to beta block medication, or volitional termination by participant. Vital signs were monitored throughout the test and cool down period. Peak VO2 values for this cohort ranged from 14.04 to 36.48 ml/kg/min, with higher values correlated to higher fitness level.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Cardiovascular Fitness (Submaximal VO2)
Baseline Submaximal VO2
|
26.12 ml/kg/min
Standard Deviation 6.78
|
27.73 ml/kg/min
Standard Deviation 8.13
|
30.40 ml/kg/min
Standard Deviation 7.61
|
24.17 ml/kg/min
Standard Deviation 4.84
|
|
Cardiovascular Fitness (Submaximal VO2)
Week 12 Submaximal V02
|
24.23 ml/kg/min
Standard Deviation 3.47
|
23.52 ml/kg/min
Standard Deviation 3.20
|
33.89 ml/kg/min
Standard Deviation 10.29
|
22.85 ml/kg/min
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 2 participants were excluded from analyses due to lack of usable data at both time points.
Brain imaging conducted with a 7 Tesla scanner. Of particular interest were changes in hippocampal volume, GABA, and glutamate. The changes regarding hippocampal volumes are reported below. This measurement is reported in mm\^3, with higher numbers indicating higher levels of gray matter in the hippocampal region. Volume is combined between right and left hemispheres. GABA and glutamate are not reported. The method used to obtain the data was being piloted for this study, and due to methodological challenges, the data is not considered to be accurate and therefore cannot be analyzed/shared.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=3 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=3 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI)
Baseline Hippocampal Volume
|
6703 mm^3
Standard Deviation 839
|
6579 mm^3
Standard Deviation 253
|
6192 mm^3
Standard Deviation 1022
|
5652 mm^3
Standard Deviation 902
|
|
Functional Magnetic Resonance Imaging (fMRI)
Week 12 Hippocampal Volume
|
6035 mm^3
Standard Deviation 1850
|
6511 mm^3
Standard Deviation 362
|
6040 mm^3
Standard Deviation 894
|
6091 mm^3
Standard Deviation 899
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 1 participant in the Venlafaxine XR Only (20-39 Years) group was excluded from analyses as he/she was non-compliant with the medication regimen. Another participant in the "Venlafaxine XR Only (60-79 Years of Age)" was excluded from analyses as he/she was unable to complete Week 12 testing due to physical limitations.
The battery evaluates several cognitive domains. The Wechsler Adult Intelligence Scale, 4th ed. Digit Span subtest assesses attention and working memory. The Repeatable Battery of Neuropsychological Status (RBANS) measures Immediate and Delayed Memory, Attention, Language Abilities, and Visuospatial Functioning. Total index scores range from 40-155. The California Verbal Learning Test, 2nd Ed. (CVLT) assesses non-contextual verbal learning and memory. Z-scores are calculated for each of the constructs assessed by the CVLT. Subtests from the Deli-Kaplan Executive Function System (D-KEFS) assess aspects of executive functioning, including set-shifting (Trail Making Test Conditions 4 and 5: scaled score ranging from 0-19) and inhibition (Color-Word Interference Test Condition 3: weighted scaled score ranging from 1-19). Given that standardized scores are calculated for each of the neuropsychological measures, higher scores always indicate better cognitive functioning.
Outcome measures
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 Participants
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=2 Participants
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline CVLT Long Delay Free Recall
|
6.50 units on a scale
Standard Deviation 7.78
|
10.00 units on a scale
Standard Deviation 8.49
|
12.00 units on a scale
Standard Deviation 4.55
|
8.50 units on a scale
Standard Deviation 2.12
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 CVLT Long Delay Free Recall
|
3.00 units on a scale
Standard Deviation 4.24
|
12.50 units on a scale
Standard Deviation 3.54
|
13.50 units on a scale
Standard Deviation 3.00
|
7.50 units on a scale
Standard Deviation 2.12
|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline Color Word Interference Condition 3
|
9.00 units on a scale
Standard Deviation 5.66
|
10.00 units on a scale
Standard Deviation 1.41
|
11.25 units on a scale
Standard Deviation 2.87
|
7.50 units on a scale
Standard Deviation 0.71
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 Digit Span Backwards
|
7.50 units on a scale
Standard Deviation 2.12
|
8.50 units on a scale
Standard Deviation 0.71
|
9.00 units on a scale
Standard Deviation 1.83
|
6.50 units on a scale
Standard Deviation 0.71
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 Color Word Interference Condition 3
|
7.50 units on a scale
Standard Deviation 4.95
|
10.50 units on a scale
Standard Deviation 0.71
|
9.75 units on a scale
Standard Deviation 4.72
|
10.00 units on a scale
Standard Deviation 2.83
|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline RBANS Total Index Score
|
77.00 units on a scale
Standard Deviation 0.00
|
96.00 units on a scale
Standard Deviation 19.80
|
101.00 units on a scale
Standard Deviation 13.78
|
80.00 units on a scale
Standard Deviation 7.07
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 RBANS Total Index Score
|
81.50 units on a scale
Standard Deviation 3.54
|
100.50 units on a scale
Standard Deviation 17.68
|
102.75 units on a scale
Standard Deviation 19.74
|
85.50 units on a scale
Standard Deviation 7.78
|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline DKEFS Trailmaking
|
10.00 units on a scale
Standard Deviation 0.00
|
11.00 units on a scale
Standard Deviation 1.41
|
9.50 units on a scale
Standard Deviation 1.29
|
4.50 units on a scale
Standard Deviation 2.12
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 DKEFS Trailmaking
|
5.50 units on a scale
Standard Deviation 3.54
|
10.50 units on a scale
Standard Deviation 0.71
|
10.00 units on a scale
Standard Deviation 1.41
|
5.50 units on a scale
Standard Deviation 3.54
|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline Digit Span Forward
|
7.00 units on a scale
Standard Deviation 1.41
|
7.50 units on a scale
Standard Deviation 0.71
|
11.75 units on a scale
Standard Deviation 2.22
|
10.00 units on a scale
Standard Deviation 1.41
|
|
Neurocognitive Function (Neuropsychological Battery)
Week 12 Digit Span Forward
|
7.00 units on a scale
Standard Deviation 1.41
|
9.00 units on a scale
Standard Deviation 1.41
|
12.00 units on a scale
Standard Deviation 1.41
|
8.50 units on a scale
Standard Deviation 2.12
|
|
Neurocognitive Function (Neuropsychological Battery)
Baseline Digit Span Backwards
|
7.00 units on a scale
Standard Deviation 2.83
|
7.00 units on a scale
Standard Deviation 1.41
|
9.75 units on a scale
Standard Deviation 1.71
|
7.00 units on a scale
Standard Deviation 1.41
|
Adverse Events
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Venlafaxine XR Only (60-79 Years of Age)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Venlafaxine XR Only (20-39 Years of Age)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)
n=2 participants at risk
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (60-79 Years of Age)
n=3 participants at risk
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
Aerobic Exercise + Venlafaxine XR (20-39 Years of Age)
n=4 participants at risk
Venlafaxine (Effexor) Extended-Release (XR) comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Exercise will include walking on a treadmill 1 hour 3 times/week for 12 weeks. The intensity of the exercise will start at 50% of the age-based maximum for the first week and then increase and be maintained at 60-70% of the age-based maximum for the remainder of the intervention.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
|
Venlafaxine XR Only (20-39 Years of Age)
n=4 participants at risk
Venlafaxine (Effexor) XR comes in capsule form and is taken by mouth. Target dose will be 150mg/d, with a maximum dose of 300mg/d (response dependent) for a minimum of 12 weeks.
Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. This will be administered in pill form (2mg or less per 24 hours).
Lorazepam: Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
|
|---|---|---|---|---|
|
General disorders
Dry mouth
|
50.0%
1/2 • 12 weeks
|
100.0%
3/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
General disorders
Drowsiness
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Eye disorders
Blurred vision
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Increased appetite
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Decreased appetite
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
50.0%
1/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Renal and urinary disorders
Problems with urination
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Reproductive system and breast disorders
Problems with Sexual Function
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Feeling light-headed on standing
|
0.00%
0/2 • 12 weeks
|
100.0%
3/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Feeling like the room is spinning
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Sweating
|
0.00%
0/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
75.0%
3/4 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
|
General disorders
Increased Body Temperature
|
0.00%
0/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
50.0%
2/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
General disorders
Tremor
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Disorientation
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Yawning
|
50.0%
1/2 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
|
Metabolism and nutrition disorders
Weight Gain
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Stiff Neck
|
0.00%
0/2 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Gastrointestinal disorders
Bloatedness
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Agitation
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
General disorders
Jaw pain
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
0.00%
0/4 • 12 weeks
|
25.0%
1/4 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place