Clinical trial NCT03065933: An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
Official title: An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorder, Mania
Keywords: mania
clonidine
bipolar disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score on a Mania Rating Scale
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mclean Hospital
name: Bruce Cohen, MD, PhD
role: STUDY_CHAIR
References: