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

Overview

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.

Full Title of Study: “An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

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

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

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Score on a Mania Rating Scale
    • Time Frame: 3 days
    • Mania rating scale to be performed each day of this 3 day study.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mclean Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizabeth S. Liebson, PI – Mclean Hospital
  • Overall Official(s)
    • Bruce Cohen, MD, PhD, Study Chair, Mclean Hospital

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