Trial Outcomes & Findings for Inositol and Omega-3 Fatty Acids in Pediatric Mania (NCT NCT01396486)
NCT ID: NCT01396486
Last Updated: 2020-08-13
Results Overview
The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
Results posted on
2020-08-13
Participant Flow
While 69 subjects enrolled in the study, only 61 were randomized. Of the 8 subjects who enrolled but were not randomized, 3 were found ineligible, 3 withdrew, and 2 were lost to follow-up.
Participant milestones
| Measure |
Omega-3/Placebo
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
22
|
|
Overall Study
Exposed
|
19
|
16
|
17
|
|
Overall Study
COMPLETED
|
10
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inositol and Omega-3 Fatty Acids in Pediatric Mania
Baseline characteristics by cohort
| Measure |
Omega-3/Placebo
n=19 Participants
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
n=16 Participants
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
n=17 Participants
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.8 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
8.4 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
8.3 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
YMRS
|
26.1 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
25.8 units on a scale
STANDARD_DEVIATION 6.5 • n=7 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
25.4 units on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.
Outcome measures
| Measure |
Omega-3/Placebo
n=19 Participants
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
n=16 Participants
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
n=17 Participants
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
|---|---|---|---|
|
Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS)
|
-4.8 units on a scale
Standard Deviation 7.9
|
-6.4 units on a scale
Standard Deviation 6.4
|
-10.2 units on a scale
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.
Outcome measures
| Measure |
Omega-3/Placebo
n=19 Participants
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
n=16 Participants
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
n=17 Participants
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
|---|---|---|---|
|
Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS)
|
-4.9 units on a scale
Standard Deviation 10.6
|
-5.6 units on a scale
Standard Deviation 10.1
|
-10.8 units on a scale
Standard Deviation 7.4
|
Adverse Events
Omega-3/Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo/Inositol
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Omega-3/Inositol
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omega-3/Placebo
n=20 participants at risk
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
n=19 participants at risk
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
n=22 participants at risk
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
|---|---|---|---|
|
Psychiatric disorders
Agitated/Irritable
|
5.0%
1/20 • Number of events 1 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • Number of events 1 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
Other adverse events
| Measure |
Omega-3/Placebo
n=20 participants at risk
Combination Omega-3 and Placebo treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
|
Placebo/Inositol
n=19 participants at risk
Combination Placebo and Inositol treatment.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
Omega-3/Inositol
n=22 participants at risk
Combination Omega-3 and Inositol treatment.
Omega-3: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
Inositol: Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
|
|---|---|---|---|
|
Psychiatric disorders
Tics
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Gastrointestinal disorders
Nausea/Vomit/Diarrhea
|
20.0%
4/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
13.6%
3/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Infections and infestations
Cold/Infection/Allergy
|
15.0%
3/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Psychiatric disorders
Agitated/Irritable
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
10.5%
2/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Headache
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Nervous system disorders
Sedation
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Increased Appetite
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
10.5%
2/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Thirsty
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Dizzy/Lightheaded
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Bet Wetting
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Irregular Behavior
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Weight Gain
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Nervous system disorders
Neurological
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Nervous system disorders
Autonomic
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Infections and infestations
Strep Throat
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Psychiatric disorders
Psychotic Episode
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Nervous system disorders
Sleep Walking
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Injury, poisoning and procedural complications
Scrape
|
5.0%
1/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
General disorders
Chewing Inside of Cheek
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
5.3%
1/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
|
Psychiatric disorders
Agitated with Homicidal Statements
|
0.00%
0/20 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
0.00%
0/19 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
4.5%
1/22 • 12 weeks
Consistent with good clinical practice, safety will be monitored by each subject's study clinician at each study visit. Subjects will be monitored by the study clinician for adverse events at each visit and adverse events will be recorded on an Adverse Events Form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place