Status:
COMPLETED
Tamoxifen in Treatment of Acute Mania
Lead Sponsor:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Objective: Evidence indicates that the protein kinase C-PKC signaling cascade may be one of the direct targets in treatment of mania. The aim of this study is to investigate whether the PKC inhibitor-...
Detailed Description
Patients aged 18-65 years, diagnosed with Bipolar Disorder (BD), most recent episode manic or mixed, with or without psychotic features were admitted to the inpatient unit at the Dokuz Eylul Universit...
Eligibility Criteria
Inclusion
- diagnosis of BD I, most recent episode, manic or mixed,
- ages 18-65,
- Young Mania Rating Scale (YMRS) score \> 20 at screening and baseline,
- providing written informed consent.
Exclusion
- currently pregnant, planning to become pregnant, or breast feeding,
- history of any coagulopathies, deep vein thrombosis, pulmonary embolus,
- a history of hypersensitivity to tamoxifen,
- drug screen positive for any drug of abuse at screening, active substance abuse in the past 2 weeks or substance dependence in the past 2 months (except nicotine and caffeine),
- diagnosis of schizophrenia, dementia, delirium, seizure disorder, obsessive compulsive disorder, or major cardiac, hepatic or renal disease that is unstable or that requires medical care,
- administration of any other investigational drug in the last 30 days,
- clinically significant suicidal or homicidal ideation.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00411203
Start Date
April 1 2003
End Date
June 1 2006
Last Update
July 31 2014
Active Locations (1)
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1
Dokuz Eylül University, Department of Psychiatry
Izmir, Turkey (Türkiye), 35340