Prazosin as an Antimanic Agent in Severe Mania or Mixed States

June 15, 2012 updated by: Elizabeth S. Liebson, Mclean Hospital

Prazosin as an Antimanic Agent in Severe Mania or Mixed Episodes: a Double-blind, Placebo-controlled Study

Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of mania involves directly targeting this hyperexcitable state by reducing arousal with antiadrenergic agents. This can be achieved by decreasing norepinephrine release by stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors. Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the treatment of mania.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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:

  • Age 18-60
  • Primary diagnosis of bipolar disorder with severe mania or mixed episode
  • YMRS score of > 20
  • Documented medical evaluation without acute or serious medical illness
  • Negative pregnancy test
  • Healthy functioning liver

Exclusion Criteria:

  • Lack of capacity to provide informed consent
  • Involuntary commitment
  • Low blood pressure
  • History of adverse reaction or allergy to prazosin or other quinazolines
  • Informed consent not given or retracted during study
  • History of narcolepsy
  • Unstable or acute medical illness

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Prazosin and placebo will be gradually titrated over 10 days to a final dose of 10 mg/day, given in divided doses (three times a day). During this time subjects will be monitored for adverse effects to prazosin and manic symptoms will be monitored. Vital signs will be monitored three times a day throughout the study. If a subject receiving prazosin or placebo develops distressing adverse effects, the dose will be decreased to the next lower dose.If there is a greater than 15 mg mercury postural fall in systolic bBP, dosing will be held at the previous day's dose.Subjects who do not tolerate prazosin or placebo will be discharged from the study.
Active Comparator: prazosin
Add prazosin to usual medications and monitor manic symptoms and for adverse effects
Drug: Addition of prazosin to usual care (add-on study)
Prazosin and placebo will be gradually titrated over 10 days to a final dose of 10 mg/day, given in divided doses (three times a day). During this time subjects will be monitored for adverse effects to prazosin and manic symptoms will be monitored. Vital signs will be monitored three times a day throughout the study. If a subject receiving prazosin or placebo develops distressing adverse effects, the dose will be decreased to the next lower dose.If there is a greater than 15 mg mercury postural fall in systolic bBP, dosing will be held at the previous day's dose.Subjects who do not tolerate prazosin or placebo will be discharged from the study.
Other Names:
  • Minipress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Young Mania Rating Scale (YMRS)
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mania Acute Changes Scale (MACS)
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Investigators

  • Principal Investigator: Elizabeth S Liebson, MD, 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

March 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12909

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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