Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms - NCT00431184-02478 (Clinical Trial 161988)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy161988.aspx
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| City: |
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Belmont |
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State:
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MA |
| Zip Code: |
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02478 |
| Conditions: |
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Bipolar Disorder - Schizoaffective Disorder - Manic Disorder - Mania - Manic State |
| Purpose: |
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Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals.
To follow up these initial findings, we plan to conduct a larger, more rigorous,
double-blind study. We will examine whether pentazocine, an agent with kappa-opiate
activity, decreases manic symptoms.
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| Study summary: |
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Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such
as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for
bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target
this system particularly promising as a treatment modality, with relatively low risk of
addictive properties. Pentazocine is an approved drug for pain relief with a good side
effect profile. It is predominantly a kappa opioid agonist with weaker side effects at mu
opioid receptors, at which it is an antagonist. Data from our open-label pilot study of
pentazocine had promising results. We will follow up on these findings with a double-blind,
placebo, and active-control study of individuals with bipolar disorder or schizoaffective
disorder who are currently hospitalized with acute mania. The antimanic effects of
pentazocine will be compared with a placebo control at one site, and with an active control
(ativan)at the second site. |
| Criteria: |
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Inclusion Criteria:
- bipolar or schizoaffective disorder
- currently manic
- no acute medical issues
- no substance withdrawal
Exclusion Criteria:
- unable to give informed consent
- using opiates for pain management
- history of head injury, dementia, or mental retardation
- seizure disorder
- glaucoma
- unstable cardiac condition or arrhythmia
- moderate-severe pulmonary disease
- pregnancy |
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| Study is available at: |
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McLean Hospital
Belmont, MA 02478
United States
Primary Contact:
Jin K
Phone: 617-855-2540
Secondary Contact:
Sue B
Phone: 617-855-3184 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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