- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065933
An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
March 15, 2017 updated by: Elizabeth S. Liebson, Mclean Hospital
An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
5
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on a Mania Rating Scale
Time Frame: 3 days
|
Mania rating scale to be performed each day of this 3 day study.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Bruce Cohen, MD, PhD, McLean Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
November 6, 2012
First Submitted That Met QC Criteria
February 22, 2017
First Posted (Actual)
February 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
March 15, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympatholytics
- Clonidine
Other Study ID Numbers
- 2011-P-002018/1; McLean
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
IPD to be shared via clinicaltrials.gov,
publication, or personal request.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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