NCT00431184

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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, 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 an active control (ativan).

Conditions

• Bipolar Disorder
• Schizoaffective Disorder
• Manic Disorder
• Mania
• Manic State

Interventions

Type	Name	Description
DRUG	Pentazocine	see arms description
DRUG	Lorazepam	see arms description

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-02-05
• Last updated: 2019-03-06
• Results posted: 2014-08-21

Locations

1 site across 1 country: United States