An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression
Overview
- Phase
- Phase 4
- Intervention
- Duloxetine hydrochloride
- Conditions
- Major Depressive Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 339
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
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
- •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
Arms & Interventions
Duloxetine Hydrochloride (60 mg)
Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO). Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo
Intervention: Duloxetine hydrochloride
Duloxetine Hydrochloride (60 mg)
Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO). Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo
Intervention: Placebo
Duloxetine Hydrochloride (120 mg)
Up to Week 4: 60 mg every morning and 60 mg every evening, PO. Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose
Intervention: Duloxetine hydrochloride
Duloxetine Hydrochloride (120 mg)
Up to Week 4: 60 mg every morning and 60 mg every evening, PO. Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline to Week 4
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Secondary Outcomes
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline(Baseline to Weeks 1, 2, 3, 4, 6, 8)
- Clinical Global Impression of Improvement (CGI-I) at Each Visit(Weeks 1, 2, 3, 4, 6, 8)
- Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)(4 to 8 weeks)
- Number of Patients With Potentially Clinically Significant Laboratory Findings(over 8 weeks)
- Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline(Baseline to Weeks 1, 2, 3, 4, 6, 8)
- Clinical Global Impression of Severity (CGI-S) Scores at Each Visit(Baseline, Weeks 1, 2, 3, 4, 6, 8)
- Percentage of Responders(4 to 8 weeks)
- Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication(over 8 weeks)
- Patient Global Impression of Improvement (PGI-I) Score at Each Visit(Weeks 1, 2, 3, 4, 6, 8)
- Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8(Baseline and Weeks 4 and 8)
- Patients Reaching Remission(Week 8)
- Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study(over 8 weeks)
- Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8(Baseline and Week 8)
- Change From Baseline to Week 4 and Week 8 in Weight(Baseline to Weeks 4 and 8)
- Discontinuations Due to Adverse Events (AE)(over 8 weeks)