Phase 4
Completed N=339
A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression
Source: ClinicalTrials.gov NCT00422162 ↗Enrolled (actual)
339
Serious AEs
—
Results posted
Oct 2009
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.