Trial Outcomes & Findings for Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (NCT NCT01654796)
NCT ID: NCT01654796
Last Updated: 2017-09-05
Results Overview
The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Baseline and 48 hours after initiating treatment
Results posted on
2017-09-05
Participant Flow
Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data. Adverse events are reported for all 85 subjects.
Participant milestones
| Measure |
Low Field Magnetic Stimulation
Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
|
Sham (LFMS)
Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
Sham LFMS First, Then Active LFMS
Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
29
|
29
|
|
Overall Study
COMPLETED
|
25
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
Baseline characteristics by cohort
| Measure |
Low Field Magnetic Stimulation
n=26 Participants
Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
|
Sham (LFMS)
n=29 Participants
Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
Crossover Arm
n=29 Participants
Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 10 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
82 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
PRIMARY outcome
Timeframe: Baseline and 48 hours after initiating treatmentPopulation: Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.
The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.
Outcome measures
| Measure |
Phase 1 Active LFMS
n=26 Participants
Participants in this group receive Active LFMS treatment for 2 days in Phase 1.
|
Phase 1 Sham LFMS
n=58 Participants
Participants in this group received Sham LFMS treatment for 2 days in Phase 1.
|
Phase 2 Active LFMS
n=18 Participants
Participants in this group received Active LFMS treatment for 2 days in Phase 2.
|
Phase 2 Sham LFMS
n=21 Participants
Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
|
|---|---|---|---|---|
|
Hamilton Rating Scale for Depression - 6 Items
Baseline
|
11.7 units on a scale
Standard Deviation 2.2
|
11.3 units on a scale
Standard Deviation 2.1
|
10.9 units on a scale
Standard Deviation 2.2
|
9.4 units on a scale
Standard Deviation 2.3
|
|
Hamilton Rating Scale for Depression - 6 Items
End of Phase
|
8.8 units on a scale
Standard Deviation 2.5
|
8.1 units on a scale
Standard Deviation 3.7
|
9.6 units on a scale
Standard Deviation 3.9
|
8.0 units on a scale
Standard Deviation 3.7
|
|
Hamilton Rating Scale for Depression - 6 Items
Score Change
|
-2.8 units on a scale
Standard Deviation 2.5
|
-3.2 units on a scale
Standard Deviation 3.3
|
-1.3 units on a scale
Standard Deviation 3.7
|
-1.5 units on a scale
Standard Deviation 2.4
|
Adverse Events
Low Field Magnetic Stimulation
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Sham (LFMS)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Crossover Arm
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Field Magnetic Stimulation
n=27 participants at risk
Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
|
Sham (LFMS)
n=29 participants at risk
Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
Crossover Arm
n=29 participants at risk
Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
22.2%
6/27 • Number of events 9
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
34.5%
10/29 • Number of events 17
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
17.2%
5/29 • Number of events 7
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Vascular disorders
Dizziness
|
3.7%
1/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 4
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Irritability
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
10.3%
3/29 • Number of events 3
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
13.8%
4/29 • Number of events 4
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Vascular disorders
Blood Pressure Increased
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 4
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Disturbance in Attention
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 3
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Somnolence
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Vascular disorders
Hot Flush
|
14.8%
4/27 • Number of events 4
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Memory Impairment
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Myalgia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 3
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Sleep Disorder
|
3.7%
1/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Abnormal Dreams
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
10.3%
3/29 • Number of events 3
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Renal and urinary disorders
Pollakiuria
|
7.4%
2/27 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Aphasia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Bruxism
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Cardiac disorders
Electrocardiogram Abnormal
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Fatigue
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Hiccups
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Migraine
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
6.9%
2/29 • Number of events 2
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Pain in Extremity
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Psychomotor Hyperactivity
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Abdominal Discomfort
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Abdominal Pain Lower
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Asthenia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Confusional State
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Decreased Appetite
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Dehydration
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Drooling
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Cardiac disorders
Heart Rate Increased
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Endocrine disorders
Hyperlycemia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Endocrine disorders
Hypoglycemia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Renal and urinary disorders
Hypokalemia
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Libido Decreased
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Medial Tibial Stress Syndrome
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Eye disorders
Myodesopsia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Obsessive-Compulsive Disorder
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Orgasm Abnormal
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Endocrine disorders
Parathyroid Tumor Benign
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Vascular disorders
Presyncope
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Sinus Congestion
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Sinus Headache
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Vascular disorders
Syncope
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Tension
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Musculoskeletal and connective tissue disorders
Tooth Fracture
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Nervous system disorders
Tremor
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Weight Decreased
|
3.7%
1/27 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
|
General disorders
Weight Increased
|
0.00%
0/27
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
3.4%
1/29 • Number of events 1
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
0.00%
0/29
The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place