Phase 4
N=339
A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00422162 ↗Enrolled (actual)
339
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — 36.1; 36.0; -20.1; -19.9 units on a scale — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
36.1; 36.0; -20.1; -19.9 | 0.88 |
| SECONDARY Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline |
-3.9; -1.9; -3.3; -1.7; -3.1; -2.7 | — |
| SECONDARY Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline |
-10.3; -5.6; -8.8; -5.6; -8.3; -7.6 | — |
| SECONDARY Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6) |
-1.0; -7.2; -2.6; -5.8; -2.6; -10.9 | — |
| SECONDARY Clinical Global Impression of Severity (CGI-S) Scores at Each Visit |
5.0; 5.1; 4.4; 4.4; 3.6; 3.8 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) at Each Visit |
3.1; 3.2; 2.5; 2.6; 2.3; 2.3 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Score at Each Visit |
3.0; 3.1; 2.6; 2.6; 2.3; 2.4 | — |
| SECONDARY Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8 |
26.0; 27.0; 13.0; 13.4; 9.6; 9.8 | — |
| SECONDARY Percentage of Responders |
100.0; 2.9; 100.0; 4.7; 94.8; 52.9 | — |
| SECONDARY Patients Reaching Remission |
85; 29; 94; 18; 11; 41 | — |
| SECONDARY Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8 |
4.0; 3.6; 3.7; 3.7; 3.8; 3.7 | <0.0001 sig |
| SECONDARY Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication |
65; 59; 93; 88; 95; 89 | — |
| SECONDARY Number of Patients With Potentially Clinically Significant Laboratory Findings |
0; 1; 2; 2; 0; 1 | — |
| SECONDARY Discontinuations Due to Adverse Events (AE) |
11; 9; 3; 0; 2; 1 | — |
| SECONDARY Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study |
23; 25; 28; 37; 10; 14 | — |
| SECONDARY Change From Baseline to Week 4 and Week 8 in Weight |
0.1; 0.0; 0.5; 0.1 | — |
Summary
An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.
Eligibility Criteria
Inclusion Criteria
Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, [DSM-IV] and confirmed by Mini International Neuropsychiatric Interview [MINI]).
- With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
- Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4.
- Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
- Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure.
Exclusion Criteria
- More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
- Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
- Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment.
- Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.
- Depression with catatonic features (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
- The presence of an Axis II disorder
Data sourced from ClinicalTrials.gov (NCT00422162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.