Prazosin as an Antimanic Agent in Severe Mania or Mixed States

NCT01621165 | Withdrawn

• 1 other identifier: 12909
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  10 days

Secondary Outcomes (1)

• Mania Acute Changes Scale (MACS)

  10 days

Study Arms (2)

prazosin

ACTIVE COMPARATOR

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

Drug: Addition of prazosin to usual care (add-on study)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Addition of prazosin to usual care (add-on study) DRUG

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.

Also known as: Minipress

prazosin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

MeSH Terms

Conditions

Mania

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elizabeth S Liebson, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: June 18, 2012
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 18, 2012

Record last verified: 2012-06