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

• ClinicalTrials.gov Identifier: NCT03065933
• Recruitment Status: Terminated
• First Posted: February 28, 2017
• Results First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Sponsor: Mclean Hospital
• Information provided by (Responsible Party): Elizabeth S. Liebson, Mclean Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder, Mania	Drug: extended-release clonidine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Intervention Model: Single Group Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study
• Study Start Date: January 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: extended-release clonidine; Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.; Other Name: Kapvay

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Mclean Hospital

Investigators

• Study Chair: Bruce Cohen, MD, PhD; Mclean Hospital

More Information

• Responsible Party: Elizabeth S. Liebson, PI, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03065933 History of Changes
• Other Study ID Numbers: 2011-P-002018/1; McLean
• First Posted: February 28, 2017
• Results First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD to be shared via clinicaltrials.gov, publication, or personal request.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elizabeth S. Liebson, Mclean Hospital:

mania; clonidine; bipolar disorder

Additional relevant MeSH terms:

Clonidine; Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders; Antimanic Agents; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs