Frequency of treatment-emergent sexual dysfunction and treatment effectiveness during SSRI or duloxetine therapy: 8-week data from a 6-month observational study.

BACKGROUND: In randomised controlled trials, the frequency of treatment-emergent sexual dysfunction (TESD) in patients with major depressive disorder (MDD) at week 8 was lower with duloxetine than selective serotonin reuptake inhibitor (SSRI) therapy. METHODS: This 6-month, prospective, observational study compared the frequency of TESD (using the Arizona Sexual Experience [ASEX] scale) in MDD patients treated with duloxetine or SSRI monotherapy in the first 8 weeks in normal clinical practice. RESULTS: Physician-assessed TESD frequency at week 8 was comparable with duloxetine and SSRI monotherapy (23.9 and 26.2%, respectively; P = 0.545). Improvements in Clinical Global Impressions of Severity (CGI-S), 16-item Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR(16)), Integral Inventory for Depression (IID) total scores and remission rates were statistically significantly greater with duloxetine than SSRI monotherapy (P < 0.001, 0.010, <0.001, and 0.002, respectively), but TESD attenuated improvements in quality of life measures (EuroQoL questionnaire-5 dimensions [EQ-5D] and Sheehan Disability Scale [SDS] scores: ≤0.012). Several factors were significantly (P ≤ 0.05) associated with TESD at week 8 in this study. CONCLUSIONS: TESD rates with duloxetine and SSRIs at week 8 were comparable, however, significant differences in effectiveness were observed in favour of duloxetine. Antidepressant tolerability with respect to TESD must be managed to maximize remission of depressed patients.

Twelve-month prospective, multinational, observational study of factors associated with recovery from mania in bipolar disorder in patients treated with atypical antipsychotics.

OBJECTIVES: Atypical antipsychotic agents constitute one therapeutic approach for bipolar disorder. Since disease course and outcome are variable, further studies are needed to complement limited data supportive of clinical decisions at treatment initiation. METHODS: This 12-month, prospective, observational study investigated factors associated with symptomatic remission (total YMRS score < or =12) and full clinical recovery (sustained reduction in CGI-BP-S overall score) in bipolar disorder during treatment with atypical antipsychotics (predominantly olanzapine, risperidone and quetiapine; alone or in combination with a psychotropic such as lithium or valproate) in actual clinical practice. RESULTS: Amongst 872 enrolled and eligible patients, rates of symptomatic remission and full clinical recovery at 12 months were 93.0 and 78.5%, respectively. Of the baseline factors significantly (P< or =0.05) associated with symptomatic remission, the following categories were positively associated with a higher chance of symptomatic remission: Caucasian ethnicity; higher CGI-BP-S scores; family-dependent living; a previous manic episode; 1, 2 or > or =5 social activities; no work impairment; and being neither satisfied nor dissatisfied with life. Outpatient treatment and historically longer periods of mania were significantly positively associated with full clinical recovery. CONCLUSIONS: While clinical status may also be associated with longer-term remission and recovery, factors relating to social functioning and quality of life are easily assessed and potentially modifiable. Such knowledge may aid physicians' clinical decisions regarding patients with bipolar mania treated with atypical antipsychotics.