Prazosin as an Antimanic Agent in Severe Mania or Mixed States

This study has been withdrawn prior to enrollment.
(unable to recruit subjects given short length of stay in hospital)
Sponsor:
Information provided by (Responsible Party):
Elizabeth S. Liebson, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01621165
First received: March 17, 2009
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Bipolar, Mania
Bipolar, Mixed State
Drug: Addition of prazosin to usual care (add-on study)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prazosin as an Antimanic Agent in Severe Mania or Mixed Episodes: a Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mania Acute Changes Scale (MACS) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Minipress
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621165

Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Elizabeth S Liebson, MD Mclean Hospital
  More Information

No publications provided

Responsible Party: Elizabeth S. Liebson, PI, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01621165     History of Changes
Other Study ID Numbers: 12909
Study First Received: March 17, 2009
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
treatment of bipolar, mania
double-blind, placebo-controlled study
drug intervention
add-on study
prazosin
alpha-1 adrenergic antagonist

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Prazosin
Adrenergic Antagonists
Antimanic Agents
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 24, 2014