Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial.

OBJECTIVE: To assess whether hospitalized patients with severe depression and potential suicidal ideation/behavior have earlier and better response to duloxetine 120 mg daily than 60 mg daily. METHOD: Adults from 34 sites in 4 countries with severe major depressive disorder, defined by DSM-IV criteria, who were demonstrating Montgomery-Asberg Depression Rating Scale (MADRS) scores ≥ 30, 6-item Hamilton Depression Rating Scale (HDRS-6) scores ≥ 12, and Clinical Global Impressions-Severity of Illness scale (CGI-S) ≥ 4 and hospitalized ≥ 2 weeks underwent double-blind treatment with either duloxetine 60 mg (n = 167) or 120 mg (n = 171) daily for 8 weeks. Patients treated with 60 mg/d who did not respond had their doses titrated up to 120 mg/d. Primary outcome was the difference in baseline to week 4 change in MADRS scores between the groups. Secondary outcomes were baseline to week 8 changes in MADRS and HDRS-6 scores, response and remission, CGI-S scores, CGI-Improvement scores, Patient Global Impressions-Improvement, Hamilton Anxiety Rating Scale scores, and Reasons For Living inventory results. Safety was also assessed. The study was conducted between February 9, 2007, and August 26, 2008. RESULTS: There was no significant difference in mean baseline to week 4 MADRS score change between the 60-mg (-20.1) and 120-mg (-19.9) groups (P = .88). At week 4, 96/166 (60 mg) and 106/170 (120 mg) patients responded and maintained responses at week 8 by further decreasing mean MADRS scores to 5.8 (60 mg) and 5.6 (120 mg). At week 8, 226/336 (67.3%) patients achieved remission, with no difference demonstrated between groups. Most secondary efficacy measures were significantly reduced from baseline to week 8 within each group and did not differ between groups. Treatment-emergent adverse events observed with > 10% frequency in both groups were headache and nausea. CONCLUSIONS: Duloxetine 60-mg and 120-mg doses were equally effective and demonstrated no significant differences in treating severe depressive symptoms in hospitalized patients. The safety and tolerability profile of duloxetine in both dosages did not differ and was similar to those reported in previous duloxetine studies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00422162.

Italian validation of the urogenital distress inventory and its application in LUTS patients.

OBJECTIVES: The objective of this study was to validate the Italian version of the Urogenital Distress Inventory (UDI) in a sample of women with lower urinary tract symptoms (LUTS). METHODS: The linguistic validation of the questionnaire was performed through a multistep process: backward and forward translations coordinated by clinical investigators, followed by a pretest. The final version was administered to a larger sample of female patients, aged 18 years or older who had been having LUTS for at least 3 months, numbering 53 subjects. To evaluate test-retest reliability, patients were re-rated after 1 week. To test the questionnaire's capacity to discriminate women with or without LUTS (cases and controls, respectively), a sample of 53 healthy women was enrolled. A 72-h voiding diary was used as a gold standard and compared with the UDI. RESULTS: The correlation coefficient between ratings was >or=0.80, and the discriminant power between cases and controls was confirmed. The UDI showed good internal consistency for all domains, except irritative symptoms (total score's Cronbach alpha=0.86). Factor analytic structure revealed urinary incontinence to be opposite to the other urologic symptoms, with bed wetting being loaded separately. The average daily number of urgent micturitions was higher in patients who reported they "experience a strong feeling of urgency to empty bladder" in the UDI than those ones who did not (p<0.01). CONCLUSIONS: The Italian version of the UDI is a valid and robust instrument, which can now be used reliably in daily practice and clinical research.

Italian validation of the International Consultation on Incontinence Questionnaires.

OBJECTIVE: To validate the Italian version of two questionnaires for lower urinary tract symptoms (LUTS), i.e. the long (LF) and the short form (SF) of the International Consultation on Incontinence Questionnaire (ICIQ). METHODS: Two native Italian speakers and a native English speaker collaborated with clinical investigators through a multistep process to obtain a consensus version of the questionnaires. The resulting Italian versions were then pre-tested during a pilot study on 16 women for the LF and 10 for the SF. The final versions of the ICIQ-LF and ICIQ-SF were administered to two samples of consecutive female patients, aged > or = 18 years, who had been having LUTS for > or = 3 months, with respectively 82 and 50 women. Internal consistency and test-retest reliability were then assessed; to evaluate the latter, a subset of patients (25 for the ICIQ-LF and 42 for ICIQ-SF) was re-rated. To test the capacity of the questionnaires to discriminate women with or without LUTS (respectively cases and controls), a sample of healthy women was also enrolled and assessed. RESULTS: Both scales showed good psychometric properties overall. The correlation coefficient between ratings was > 0.75 in both questionnaires, and the discriminant power between cases and controls was confirmed for both scales. The ICIQ-SF showed good internal consistency for the total score (Cronbach's alpha 0.90). The sections of the ICIQ-LF 'impact of incontinence on everyday life', 'emotional aspects', 'urinary symptoms' and the degree of bother seemed to be internally consistent (Cronbach's alpha > 0.70); there was a weak relationship for items related to 'sexual matters' (Cronbach's alpha 0.38). CONCLUSION: The Italian version of both questionnaires is a valid and robust instrument which can now be used reliably both in daily practice and in clinical research.