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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Clonidine as an Antimanic Agent
STARTED   5 
COMPLETED   0 
NOT COMPLETED   5 
study terminated                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No data besides region of enrollment was collected on these participants before the study terminated.

Reporting Groups
  Description
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.


Baseline Measures
   Clonidine as an Antimanic Agent 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
  
[1] No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
  
[1] No data was collected on the 5 participants, except for region of enrollment, before the study terminated.
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 5 
United States   5 
[1] All participants were enrolled in the United States, but no other data was collected.


  Outcome Measures

1.  Primary:   Score on a Mania Rating Scale   [ Time Frame: 3 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elizabeth S. Liebson, M.D.
Organization: McLean Hospital
phone: 617-855-2284
e-mail: eliebson@partners.org



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