A Comparison of Duloxetine Dosing Strategies in The Treatment of Patients With Major Depression

简要总结

主要结局

次要结局

• The secondary objective of greatest importance is to compare the incidence of treatment-emergent nausea
• (as defined for the primary objective) for patients
• initially dosed at duloxetine 30 mg QD, versus duloxetine 30 mg BID (twice-daily).
• Additional secondary objectives include comparing the three initial dosing groups in regards to:Mean changes from baseline in the category total scores and individual items scores of the AMDP-5
• The incidence and severity of adverse events using rates of spontaneously reported treatment-emergent adverse events, rates of discontinuations due to
• adverse events, categorical changes in AMDP-5 items, mean changes and categorical changes in vital signs
• as well as mean changes and rates of abnormal laboratory analytes
• Mean changes from baseline in the HAMD17 total score, HAMD subscales, HAMD17 individual items, 30-item Inventory of Depressive Symptoms,
• Clinician Rated (IDS-30) total score and individual items, Brief Pain Inventory items and interference
• total score, Visual Analog Scales for pain, Clinical Global Impressions of Severity (CGI-Severity), Post-baseline means
• on the Patient's Global Impression of Improvement (PGI-I), Remission rates (HAMD17 total score of less than 7),
• and response rates (greater than 50% decrease from baseline on the HAMD17 total score).
• - Sexual dysfunction, as measured by categorical changes (same, better, worse) and presence vs. absence, based on the patient global assessment of sexual functioning.
• Time to onset of action in depression (30% improvement in Maier Subscale of HAMD) and painful physical symptoms (30% improvement in as measure by the BPI interference total score).