Prazosin as an Antimanic Agent in Severe Mania or Mixed States

Mass General Brigham

Status: Withdrawn

Conditions: Bipolar, Mixed State; Bipolar, Mania

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01621165

12909

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

prazosin

Active Comparator group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo