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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
Sponsor:
Information provided by (Responsible Party):
Elizabeth S. Liebson, Mclean Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder, Mania
Intervention Drug: extended-release clonidine
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clonidine as an Antimanic Agent
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 5
Completed 0
Not Completed 5
Reason Not Completed
study terminated             5
Arm/Group Title Clonidine as an Antimanic Agent
Hide Arm/Group Description

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 Number of Baseline Participants 5
Hide Baseline Analysis Population Description
No data besides region of enrollment was collected on these participants before the study terminated.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
[1]
Measure Analysis Population Description: All participants were enrolled in the United States, but no other data was collected.
1.Primary Outcome
Title Score on a Mania Rating Scale
Hide Description Mania rating scale to be performed each day of this 3 day study.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Arm/Group Title Clonidine as an Antimanic Agent
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description No data was collected on the 5 participants enrolled, except for region of enrollment, before the study terminated.
 
Arm/Group Title Clonidine as an Antimanic Agent
Hide Arm/Group Description

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.

All-Cause Mortality
Clonidine as an Antimanic Agent
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine as an Antimanic Agent
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clonidine as an Antimanic Agent
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth S. Liebson, M.D.
Organization: McLean Hospital
Phone: 617-855-2284
EMail: eliebson@partners.org
Layout table for additonal information
Responsible Party: Elizabeth S. Liebson, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03065933     History of Changes
Other Study ID Numbers: 2011-P-002018/1; McLean
First Submitted: November 6, 2012
First Posted: February 28, 2017
Results First Submitted: March 15, 2017
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017