Trial Outcomes & Findings for Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders (NCT NCT02357290)
NCT ID: NCT02357290
Last Updated: 2019-11-04
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
40 participants
Primary outcome timeframe
Baseline and Endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
Results posted on
2019-11-04
Participant Flow
Participant milestones
| Measure |
Open-Label Treatment With NAC
12-week, open-label treatment with NAC.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
Exposed
|
26
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Open-Label Treatment With NAC
n=26 Participants
12-week, open-label treatment with NAC.
|
|---|---|
|
Age, Continuous
|
10.0 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Mean Young Mania Rating Scale (YMRS) Score
|
23.8 score on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Mean Children's Depression Rating Scale (CDRS) Score
|
37.1 score on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 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 |
Open-Label Treatment With NAC
n=26 Participants
12-week, open-label treatment with NAC.
|
|---|---|
|
Mean Change in the Young Mania Rating Scale (YMRS) Score
|
-8.1 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline and 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 |
Open-Label Treatment With NAC
n=26 Participants
12-week, open-label treatment with NAC.
|
|---|---|
|
Mean Change in the Children's Depression Rating Scale (CDRS) Score
|
-5.2 score on a scale
Standard Deviation 10.7
|
Adverse Events
Open-Label Treatment With NAC
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-Label Treatment With NAC
n=29 participants at risk
12-week, open-label treatment with NAC.
|
|---|---|
|
Psychiatric disorders
Hospitalization
|
3.4%
1/29 • 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.
|
|
Psychiatric disorders
Mania
|
3.4%
1/29 • 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.
|
Other adverse events
| Measure |
Open-Label Treatment With NAC
n=29 participants at risk
12-week, open-label treatment with NAC.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Vomit/Diarrhea
|
24.1%
7/29 • Number of events 11 • 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
|
13.8%
4/29 • Number of events 4 • 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
|
13.8%
4/29 • Number of events 5 • 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
|
10.3%
3/29 • Number of events 3 • 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
Anxious/Worried
|
6.9%
2/29 • Number of events 2 • 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
|
6.9%
2/29 • Number of events 2 • 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
|
3.4%
1/29 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.4%
1/29 • 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.
|
|
General disorders
Increased Appetite
|
3.4%
1/29 • Number of events 3 • 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
|
3.4%
1/29 • Number of events 2 • 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
|
3.4%
1/29 • Number of events 3 • 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
Bike Injury (Stitches)
|
3.4%
1/29 • 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.
|
|
Psychiatric disorders
Dissociation
|
3.4%
1/29 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place