A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT00191061|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Drug: duloxetine hydrochloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison of Duloxetine Dosing Strategies in The Treatment of Patients With Major Depression|
|Study Start Date :||October 2004|
|Estimated Study Completion Date :||January 2006|
- The primary objective in the acute phase of this study is to compare the incidence of treatment-emergent nausea
- for patients initially dosed at duloxetine 30 mg QD
- (once-daily), versus duloxetine 60 mg QD.
- The primary objective in the extension phase of this study is to compare efficacy in patients not meeting response criteria during the acute phase for patients dosed at duloxetine 60 mg QD versus duloxetine 120 mg QD.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191061
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|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|