Status:
COMPLETED
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
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 disorde...
Eligibility Criteria
Inclusion
- bipolar or schizoaffective disorder
- currently manic
- no acute medical issues
- no substance withdrawal
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00431184
Start Date
January 1 2007
End Date
March 1 2011
Last Update
March 6 2019
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478