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

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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:
Information provided by (Responsible Party):
Elizabeth S. Liebson, 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.

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065933


Sponsors and Collaborators
Mclean Hospital
Investigators
Study Chair: Bruce Cohen, MD, PhD Mclean Hospital

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    Key Record Dates
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:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Clonidine
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