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Trial record 3 of 331 for:    clonidine

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

Tracking Information
First Submitted Date  ICMJE November 6, 2012
First Posted Date  ICMJE February 28, 2017
Results First Submitted Date  ICMJE March 15, 2017
Results First Posted Date  ICMJE April 26, 2017
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
Score on a Mania Rating Scale [ Time Frame: 3 days ]
Mania rating scale to be performed each day of this 3 day study.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03065933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
Official Title  ICMJE An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study
Brief Summary The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study.
Detailed Description Clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. It is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. There is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. The investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and if the rate of adverse effects is unacceptable.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder, Mania
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: extended-release clonidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • meet SCID criteria for bipolar disorder, type I, Mania with YMRS > 15
  • No significant improvement in symptoms after three or more days of hospitalization
  • documented medical evaluation without identified acute or serious medical illness
  • negative pregnancy test in women of child-bearing age

Exclusion Criteria:

  • involuntary commitment or lack of capacity to provide informed consent
  • low blood pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03065933
Other Study ID Numbers  ICMJE 2011-P-002018/1; McLean
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD to be shared via clinicaltrials.gov, publication, or personal request.
Responsible Party Elizabeth S. Liebson, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bruce Cohen, MD, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP