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

Bipolar Disorder, Mania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03065933
• Other study ID #: 2011-P-002018/1; McLean
• Status: Terminated
• Phase: Phase 4
• First received: November 6, 2012
• Last updated: February 22, 2017
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2017
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 the rate of adverse effects is unacceptable. See below for study results and reason for termination after recruiting only five subjects.

Description:

Five subjects were recruited. The extended-release form of clonidine appeared to be well-tolerated, but anti-manic effects, if any, appeared to be small. Results were difficult to interpret because of a variety of confounding factors. Only one of the five subjects did not receive the second dose of extended-release clonidine on the Treatment Day. It was not given because of sedation and hypotension; N.B. this subject was given a large dose of prn clonazepam 45 minutes after receiving the study drug. Other confounding factors included one subject being punched in the face by another patient during the study and another subject receiving unexpected good news during the study. These events likely influenced scores on rating forms. Also, subjects received a variety of prn medications during the study. Given that it appeared likely that the antimanic effect of the study medication was small, a high N would be required to confirm, and an N of 10 was deemed too low, so recruitment was stopped at five.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder, Mania

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on a mania rating scale	Mania rating scale to be performed each day of this 3 day study.	3 days