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Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms - NCT00431184-07753(Clinical Trial 161989)



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City:  Neptune
State:  
NJ
Zip Code: 07753
Conditions: Bipolar Disorder - Schizoaffective Disorder - Manic Disorder - Mania - Manic State
Purpose: 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.
Study summary: 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: 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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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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