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

Phase 4

Terminated

• Conditions: Bipolar Disorder, Mania
• Interventions: Drug: extended-release clonidine

• Registration Number: NCT03065933
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-28
• Status Verified: 2017-03
• Results First Submitted: 2017-03-15
• Results First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Results First Posted: 2017-04-26
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clonidine as an antimanic agent	extended-release clonidine	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.

Primary Outcome Measures

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