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This study has been withdrawn prior to enrollment.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:
Mclean Hospital
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
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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 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 May 16, 2013