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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-BI-HMES | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine Hydrochloride (60 mg) | Experimental | 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 |
|
| Duloxetine Hydrochloride (120 mg) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine hydrochloride | Drug | 60 mg once or twice a day, by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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). | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline | The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe). | Baseline to Weeks 1, 2, 3, 4, 6, 8 |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline |
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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]).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Besançon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20868642 | Result | Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21. | |
| 25317365 | Derived |
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Of the 392 patients who signed informed consent, 339 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine (60 mg) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks |
| FG001 | Duloxetine (120 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | placebo capsule by mouth |
|
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). |
| Baseline to 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) | Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). | 4 to 8 weeks |
| Clinical Global Impression of Severity (CGI-S) Scores at Each Visit | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline, Weeks 1, 2, 3, 4, 6, 8 |
| Clinical Global Impression of Improvement (CGI-I) at Each Visit | Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). | Weeks 1, 2, 3, 4, 6, 8 |
| Patient Global Impression of Improvement (PGI-I) Score at Each Visit | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | Weeks 1, 2, 3, 4, 6, 8 |
| Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8 | The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. | Baseline and Weeks 4 and 8 |
| Percentage of Responders | Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks. | 4 to 8 weeks |
| Patients Reaching Remission | Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8. | Week 8 |
| Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8 | The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is "not at all important" and 6 is "extremely important". The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6. | Baseline and Week 8 |
| Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication | Number of participants using medication for anxiety and sleep disturbances. | over 8 weeks |
| Number of Patients With Potentially Clinically Significant Laboratory Findings | Laboratory results that were potentially clinically significant. | over 8 weeks |
| Discontinuations Due to Adverse Events (AE) | Listing of adverse events (AE) that led to treatment discontinuation (DC). | over 8 weeks |
| Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study | Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline. | over 8 weeks |
| Change From Baseline to Week 4 and Week 8 in Weight | Change in weight = Post-baseline visit minus baseline. | Baseline to Weeks 4 and 8 |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Bordeaux | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Bully-les-Mines | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Château-Gontier | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Dijon | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Dole | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Fains-Véel | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Jarnac | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | La Charité-sur-Loire | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | La Rochelle | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Limoges | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Marseille | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Montberon | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Montpellier | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Nîmes | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Paris | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Saint-Dizier | France |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Florence | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Foggia | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Messina | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Milan | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Pisa | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Roma | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Siena | Italy |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Kazan' | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Lipetsk | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Moscow | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Nizhny Novgorod | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Saint Petersburg | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Saratov | Russia |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Bryanston | South Africa |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Cape Town | South Africa |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | George | South Africa |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Krugersdorp | South Africa |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Pretoria | South Africa |
| Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3):PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1. |
60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine (60 mg) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks |
| BG001 | Duloxetine (120 mg) | 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Previous Major Depressive Disorder Episodes | Number | participants |
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| Race/Ethnicity | Number | participants |
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| Age at First Major Depressive Episode | Mean | Standard Deviation | years |
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| Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight in kilograms divided by height in meters squared. | Mean | Standard Deviation | kilograms/square meter (kg/m^2) |
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| Duration of Previous Major Depressive Disorder (MDD) Episode | Duration of previous MDD episode in participants who experienced a previous MDD episode. | Mean | Standard Deviation | weeks |
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| Height | Mean | Standard Deviation | centimeters (cm) |
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| Number of Previous Hospitalizations | Number of hospitalizations for MDD in participants who experienced previous MDD episodes. | Mean | Standard Deviation | number of hospitalizations |
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| Number of Previous Major Depressive Disorder (MDD) Episodes | Number of previous MDD episodes for participants who experienced previous MDD episodes. | Mean | Standard Deviation | number of episodes |
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| Pulse Rate | Mean | Standard Deviation | beats per minute |
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| Weight | Mean | Standard Deviation | kilograms (kg) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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). | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 |
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| Secondary | Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline | The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe). | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Weeks 1, 2, 3, 4, 6, 8 |
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| Secondary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline | 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). | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Weeks 1, 2, 3, 4, 6, 8 |
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| 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) | Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). | All randomized participants who received at least one dose of study drug and had a Week 4 and at least one following value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Mean | Standard Deviation | units on a scale | 4 to 8 weeks |
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| Secondary | Clinical Global Impression of Severity (CGI-S) Scores at Each Visit | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 1, 2, 3, 4, 6, 8 |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) at Each Visit | Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1, 2, 3, 4, 6, 8 |
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| Secondary | Patient Global Impression of Improvement (PGI-I) Score at Each Visit | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1, 2, 3, 4, 6, 8 |
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| Secondary | Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8 | The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 4 and 8 |
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| Secondary | Percentage of Responders | Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks. | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Number | percentage of participants | 4 to 8 weeks |
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| Secondary | Patients Reaching Remission | Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8. | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Number | participants | Week 8 |
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| Secondary | Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8 | The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is "not at all important" and 6 is "extremely important". The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6. | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
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| Secondary | Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication | Number of participants using medication for anxiety and sleep disturbances. | All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. The total number of patients with hypnotics and anxiolytics concomitant therapies was 125 (Duloxetine 60mg) and 123 (Duloxetine 120mg). | Posted | Number | participants | over 8 weeks |
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| Secondary | Number of Patients With Potentially Clinically Significant Laboratory Findings | Laboratory results that were potentially clinically significant. | All randomized participants with at least one dose of study drug. | Posted | Number | participants | over 8 weeks |
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| Secondary | Discontinuations Due to Adverse Events (AE) | Listing of adverse events (AE) that led to treatment discontinuation (DC). | All randomized participants with at least one dose of study drug. | Posted | Number | participants | over 8 weeks |
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| Secondary | Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study | Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline. | All randomized participants with at least one dose of study drug. | Posted | Number | participants | over 8 weeks |
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| Secondary | Change From Baseline to Week 4 and Week 8 in Weight | Change in weight = Post-baseline visit minus baseline. | All randomized participants with at least one dose of study drug and a baseline and at least one post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | kilograms | Baseline to Weeks 4 and 8 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine (60 mg) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks | 7 | 95 | ||||
| EG001 | Duloxetine (120 mg) | 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders) | 6 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Serotonin syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| South Africa |
|
| Russian Federation |
|
| Italy |
|
| No |
|
| Black |
|
| Caucasian |
|
| Diastolic Blood Pressure |
|
| OG004 | Duloxetine 60 mg (All) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks |
| OG005 | Duloxetine 120 mg (All) | 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders) |
|
|
60mg BID for 8 weeks (placebo added at Week 4)
| OG004 | Duloxetine 60 mg (All) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks |
| OG005 | Duloxetine 120 mg (All) | 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders) |
|
|
60mg BID for 8 weeks |
| OG003 | Duloxetine 120 mg Non-Responder | 60mg BID for 8 weeks (placebo added at Week 4) |
|
|
|
|
|
|
| OG003 | Duloxetine 120 mg Non-Responders | 60mg BID for 8 weeks (placebo added at Week 4) |
|
|
| Units | Counts |
|---|
| Participants |
|
|
60mg BID for 8 weeks (placebo added at Week 4) |
| OG004 | Duloxetine 60 mg (All) | 60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks |
| OG005 | Duloxetine 120 mg (All) | 60mg BID for 8 weeks (placebo added at Week 4 for nonresponders) |
|
|
|
|
|
|
|
|