Trial Outcomes & Findings for Imaging Dopamine Release in Depression (NCT NCT02033369)
NCT ID: NCT02033369
Last Updated: 2019-11-01
Results Overview
Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2019-11-01
Participant Flow
Participant milestones
| Measure |
MDD Patients
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
Healthy Controls
Individuals without depression
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
MDD Patients
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
Healthy Controls
Individuals without depression
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Not a good demographic match
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Only 22 MDD patients started treatment. Healthy controls, as per study design, did not receive treatment.
Baseline characteristics by cohort
| Measure |
MDD Patients
n=26 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
Healthy Control Patients
n=25 Participants
Healthy control patients did not receive study medication and only have baseline measures.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Hamilton Rating Scale for Depression
|
20.3 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Snaith Hamilton Pleasure Scale
|
31.9 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Temporal Experience of Pleasure Scale - Anticipatory Subscale
|
36.1 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
49.0 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
42.4 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Mood and Anxiety Symptom Questionnaire
|
174.5 units on a scale
STANDARD_DEVIATION 28.6 • n=5 Participants
|
83.9 units on a scale
STANDARD_DEVIATION 13.3 • n=7 Participants
|
130.1 units on a scale
STANDARD_DEVIATION 50.8 • n=5 Participants
|
|
Apathy Evaluation Rating Scale
|
41.8 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 4.9 • n=7 Participants
|
33.0 units on a scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Clinical Global Impression Severity
|
3.9 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants • Only 22 MDD patients started treatment. Healthy controls, as per study design, did not receive treatment.
|
1.0 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants • Only 22 MDD patients started treatment. Healthy controls, as per study design, did not receive treatment.
|
1.9 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants • Only 22 MDD patients started treatment. Healthy controls, as per study design, did not receive treatment.
|
|
Temporal Experience of Pleasure Scale - Consummatory Subscale
|
29.9 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
38.4 units on a scale
STANDARD_DEVIATION 7.2 • n=7 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression)
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Hamilton Rating Scale for Depression
|
8.4 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Snaith Hamilton Pleasure Scale
|
26 units on a scale
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia. 18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale
|
43.2 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Mood and Anxiety Symptom Questionnaire, Short Form
|
123.1 units on a scale
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in the Apathy Evaluation Rating Scale
|
31.7 units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Clinical Global Improvement - Severity Scale
|
2.59 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia. 18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.
Outcome measures
| Measure |
Pramipexole
n=22 Participants
Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.
Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day
|
|---|---|
|
Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale
|
35.6 units on a scale
Standard Deviation 6.6
|
Adverse Events
MDD Patients
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MDD Patients
n=22 participants at risk
Only patients with MDD received treatment. There was only one arm.
|
|---|---|
|
Nervous system disorders
headache
|
59.1%
13/22 • Number of events 13 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
nausea
|
81.8%
18/22 • Number of events 18 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Heartburn
|
31.8%
7/22 • Number of events 7 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22 • Number of events 7 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Decreased Appetite
|
27.3%
6/22 • Number of events 6 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Increased Appetite
|
27.3%
6/22 • Number of events 6 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
General disorders
Dry Mouth
|
45.5%
10/22 • Number of events 10 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Number of events 4 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
22.7%
5/22 • Number of events 5 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
18.2%
4/22 • Number of events 4 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Problems
|
22.7%
5/22 • Number of events 5 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Blood and lymphatic system disorders
Bruising
|
9.1%
2/22 • Number of events 2 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
Restlessness
|
40.9%
9/22 • Number of events 9 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Musculoskeletal and connective tissue disorders
tremor
|
9.1%
2/22 • Number of events 2 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Musculoskeletal and connective tissue disorders
Impaired Coordination
|
18.2%
4/22 • Number of events 4 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
Insomnia
|
40.9%
9/22 • Number of events 9 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
General disorders
fatigue
|
9.1%
2/22 • Number of events 2 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
somnolence
|
50.0%
11/22 • Number of events 11 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
Sleep Attacks
|
22.7%
5/22 • Number of events 5 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Reproductive system and breast disorders
decreased libido
|
31.8%
7/22 • Number of events 7 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Reproductive system and breast disorders
Sexual Dysfunction
|
13.6%
3/22 • Number of events 3 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Eye disorders
Blurry Vision
|
27.3%
6/22 • Number of events 6 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Nervous system disorders
Lightheadedness
|
45.5%
10/22 • Number of events 10 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Nervous system disorders
Dizziness
|
36.4%
8/22 • Number of events 8 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
Forgetfulness
|
31.8%
7/22 • Number of events 7 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
Impaired Concentration
|
9.1%
2/22 • Number of events 2 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
|
Psychiatric disorders
compulsive behaviorws
|
13.6%
3/22 • Number of events 3 • 6 weeks
Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place