Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features

Exclusion Criteria

• •1. Have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination
• •2. Have a history of peptic ulcer disease
• •3. Have a history of severe asthma
• •4. Have a current diagnosis of pheochromocytoma
• •5. Are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit)
• •6. Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
• •7. Have a history of a psychotic disorder
• •8. Use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
• •9. Have a history of hypersensitivity to betahistine dihydrochloride
• •10. Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
• •11. Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
• •12. Have received any investigational product within 28 days of Screening
• •13. Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)