Bipolar Disorder, Mania
Conditions
Keywords
mania, clonidine, bipolar disorder
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.
Interventions
DRUGextended-release clonidine
Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Sponsors
Mclean Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on a Mania Rating Scale | 3 days | Mania rating scale to be performed each day of this 3 day study. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 5 |
Baseline characteristics
| Characteristic | — | Clonidine as an Antimanic Agent |
|---|---|---|
| Age, Continuous | — years | — |
| Region of Enrollment United States | — | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Score on a Mania Rating Scale
Mania rating scale to be performed each day of this 3 day study.
Time frame: 3 days
Population: No data was collected on the 5 participants, except for region of enrollment, before the study terminated.