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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

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.

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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.

Conditions

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Bipolar Disorder, Mania

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

extended-release clonidine

Intervention Type DRUG

Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.

Interventions

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extended-release clonidine

Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.

Intervention Type DRUG

Other Intervention Names

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Kapvay

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