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

Arm | Intervention/treatment |
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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.
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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 |
- 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 |
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

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
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 |
mania clonidine bipolar disorder |
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 |