title: Efficacy and safety of venlafaxine in the treatment of bipolar II major depressive episode.
abstract: As many as 45% of patients with major depression also meet diagnostic criteria for bipolar (BP) II disorder. Although the use of a concurrent mood-stabilizing drug has been suggested in treating BP II depression, antidepressant monotherapy has received less attention. The efficacy and safety of venlafaxine were examined in 17 BP II (mean+/-SD; age, 41+/-14 years) versus 31 unipolar (UP) (45+/-14 years) patients with major depression. Minimum pretreatment Hamilton Rating Scale for Depression (HAM-D21) score was > or = 20. After a 1-week placebo lead-in, patients were randomly assigned to receive double-blind treatment with once- versus twice-daily venlafaxine dosing starting at 37.5 mg daily and increasing up to 225 mg daily. Patients were evaluated weekly for efficacy using the HAM-D21, the Montgomery-Asberg Depression Rating Scale (MADRS), and the Clinical Global Impression (CGI) Scale. We observed a similar overall efficacy in BP and UP patients by 6 weeks of treatment (p = not significant). However, we also observed a more rapid reduction of HAM-D21 (p < 0.03) and MADRS (p < 0.02) scores by week 2 of treatment in BP patients who completed the entire trial. No episodes of venlafaxine-induced "manic switch" were observed in either patient group. In conclusion, our preliminary findings suggest that short-term, 6-week venlafaxine treatment may be a safe and effective antidepressant monotherapy for BP II major depression.
authors.affiliation: Department of Psychiatry, University of Pennsylvania Medical Center, Philadelphia, USA.
authors.forename: J
authors.initials: J
authors.lastname: Amsterdam
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
chemical_list: D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D000069470:Venlafaxine Hydrochloride