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

NCT03065933 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-04-26

Study results available
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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.

Conditions

  • Bipolar Disorder, Mania

Interventions

DRUG

extended-release clonidine

Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Bruce Cohen, MD, PhD · Mclean Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065933 on ClinicalTrials.gov