A Phase 4 interventional study of extended-release clonidine in Bipolar Disorder, Mania, sponsored by Mclean Hospital. Terminated. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by Mclean Hospital · Phase 4, Interventional, and Treatment
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.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 5 is below the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Mclean Hospital is the lead sponsor of 185 studies on the registry; 32 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
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Exclusion Criteria:
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
Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Also known as: Kapvay
Score on a Mania Rating Scale
Mania rating scale to be performed each day of this 3 day study.
Time frame: 3 days
| Milestone | Clonidine as an Antimanic Agent |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Study terminated | 5 |
Mania rating scale to be performed each day of this 3 day study.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clonidine as an Antimanic Agent | — | — | — |
No data besides region of enrollment was collected on these participants before the study terminated.
| Age, Continuous(years) | Clonidine as an Antimanic Agent |
|---|
| Sex: Female, Male(Participants) | Clonidine as an Antimanic Agent |
|---|---|
| Female | — |
| Male | — |
| Region of Enrollment(Participants) | Clonidine as an Antimanic Agent |
|---|---|
| United States | 5 |
No study locations are listed for this record.
Plan to share: Yes — IPD to be shared via clinicaltrials.gov, publication, or personal request.
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clonidine