An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
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|ClinicalTrials.gov Identifier: NCT03065933|
Recruitment Status : Terminated
First Posted : February 28, 2017
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder, Mania||Drug: extended-release clonidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects with Bipolar Disorder, mania will receive an extended-release from of clonidine on the second day of this 3-day study. Rating scale, record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days.|
|Masking:||None (Open Label)|
|Official Title:||An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: 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.
Drug: extended-release clonidine
Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Other Name: Kapvay
- Score on a Mania Rating Scale [ Time Frame: 3 days ]Mania rating scale to be performed each day of this 3 day study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065933
|Study Chair:||Bruce Cohen, MD, PhD||Mclean Hospital|