An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study

Conditions
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Bipolar Disorder, Mania

Intervention / Treatment
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* Drug: extended-release clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clonidine as an antimanic agent<br>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<br>* Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.<br>* Other names: Kapvay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on a Mania Rating Scale | Mania rating scale to be performed each day of this 3 day study. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mania, clonidine, bipolar disorder