Prazosin as an Antimanic Agent in Severe Mania or Mixed States

Not Applicable

Withdrawn

• Conditions: Bipolar, Mania; Bipolar, Mixed State
• Interventions: Drug: Addition of prazosin to usual care (add-on study); Drug: Placebo

• Registration Number: NCT01621165
• Lead Sponsor: Mclean Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-17
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-15
• Last Update Submitted: 2012-06-15
• Study First Posted: 2012-06-18
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prazosin	Addition of prazosin to usual care (add-on study)	Add prazosin to usual medications and monitor manic symptoms and for adverse effects
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Young Mania Rating Scale (YMRS)	10 days

Secondary Outcome Measures

Name	Time	Method
Mania Acute Changes Scale (MACS)	10 days