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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clonidine as an antimanic agent | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended-release clonidine | Drug | Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Cohen, MD, PhD | Mclean Hospital | Study Chair |
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IPD to be shared via clinicaltrials.gov, publication, or personal request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No data besides region of enrollment was collected on these participants before the study terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | No data was collected on the 5 participants, except for region of enrollment, before the study terminated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score on a Mania Rating Scale | Mania rating scale to be performed each day of this 3 day study. | No data was collected on the 5 participants, except for region of enrollment, before the study terminated. | Posted | 3 days |
|
|
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No data was collected on the 5 participants enrolled, except for region of enrollment, before the study terminated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth S. Liebson, M.D. | McLean Hospital | 617-855-2284 | eliebson@partners.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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.
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|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | No data was collected on the 5 participants, except for region of enrollment, before the study terminated. | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in the United States, but no other data was collected. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |