Trial Outcomes & Findings for An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study (NCT NCT03065933)
NCT ID: NCT03065933
Last Updated: 2017-04-26
Results Overview
Mania rating scale to be performed each day of this 3 day study.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
3 days
Results posted on
2017-04-26
Participant Flow
Participant milestones
| Measure |
Clonidine as an Antimanic Agent
Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Clonidine as an Antimanic Agent
Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
|
|---|---|
|
Overall Study
study terminated
|
5
|
Baseline Characteristics
No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Baseline characteristics by cohort
| Measure |
Clonidine as an Antimanic Agent
n=5 Participants
Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
|
|---|---|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants • All participants were enrolled in the United States, but no other data was collected.
|
PRIMARY outcome
Timeframe: 3 daysPopulation: No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Mania rating scale to be performed each day of this 3 day study.
Outcome measures
Outcome data not reported
Adverse Events
Clonidine as an Antimanic Agent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place