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Prazosin as an Antimanic Agent in Severe Mania or Mixed States

Primary Purpose

Bipolar, Mania, Bipolar, Mixed State

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Addition of prazosin to usual care (add-on study)
Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar, Mania focused on measuring treatment of bipolar, mania, double-blind, placebo-controlled study, drug intervention, add-on study, prazosin, alpha-1 adrenergic antagonist

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    prazosin

    Placebo

    Arm Description

    Add prazosin to usual medications and monitor manic symptoms and for adverse effects

    Outcomes

    Primary Outcome Measures

    Young Mania Rating Scale (YMRS)

    Secondary Outcome Measures

    Mania Acute Changes Scale (MACS)

    Full Information

    First Posted
    March 17, 2009
    Last Updated
    June 15, 2012
    Sponsor
    Mclean Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01621165
    Brief Title
    Prazosin as an Antimanic Agent in Severe Mania or Mixed States
    Official Title
    Prazosin as an Antimanic Agent in Severe Mania or Mixed Episodes: a Double-blind, Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    unable to recruit subjects given short length of stay in hospital
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mclean Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar, Mania, Bipolar, Mixed State
    Keywords
    treatment of bipolar, mania, double-blind, placebo-controlled study, drug intervention, add-on study, prazosin, alpha-1 adrenergic antagonist

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    prazosin
    Arm Type
    Active Comparator
    Arm Description
    Add prazosin to usual medications and monitor manic symptoms and for adverse effects
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Addition of prazosin to usual care (add-on study)
    Other Intervention Name(s)
    Minipress
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Young Mania Rating Scale (YMRS)
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    Mania Acute Changes Scale (MACS)
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth S Liebson, MD
    Organizational Affiliation
    Mclean Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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