Tamoxifen in Treatment of Acute Mania

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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-tamoxifen has anti-manic properties. Method: Bipolar subjects with manic/mixed episode were randomly assigned to receive either tamoxifen (80mg/day) or identical placebo tablets in 1:1 ratio for three weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanley Medical Research Institute
• Treatments: Citric Acid; Tamoxifen

Criteria

Inclusion Criteria:

1. diagnosis of BD I, most recent episode, manic or mixed,

2. ages 18-65,

3. Young Mania Rating Scale (YMRS) score > 20 at screening and baseline,

4. providing written informed consent.

Exclusion Criteria:

1. currently pregnant, planning to become pregnant, or breast feeding,

2. history of any coagulopathies, deep vein thrombosis, pulmonary embolus,

3. a history of hypersensitivity to tamoxifen,

4. 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),

5. 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,

6. administration of any other investigational drug in the last 30 days,

7. clinically significant suicidal or homicidal ideation.