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Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine 60 mg | Experimental | Duloxetine 60 mg |
|
| Duloxetine 120 mg | Experimental | Duloxetine 120 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline and at Week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
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Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Related Info | View source |
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Randomized (1:1), double-blind, two parallel-group trial comparing the clinical response to duloxetine 60 milligram (mg) and 120 mg per day in patients hospitalized for severe depression over a 8-week treatment period. At Week 4, participants classified by the investigator as non-responders were up-titrated to receive the higher dose duloxetine.
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| ID | Title | Description |
|---|---|---|
| FG000 | 60 mg Duloxetine | 1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). |
| FG001 | 120 mg Duloxetine | From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect.
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 mg Duloxetine | 1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). |
| 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 |
| 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 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at Week 4. |
|
From first drug administration until last drug administration (average duration of 55.1 days), plus 3 days, up to 120 days.
Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Adverse Event were analyzed by treatment arm (60 mg vs 120 mg) as prespecified in the statistical analysis plan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 60 mg Duloxetine | 1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo |
| Drug |
Capsule |
|
| At baseline and at Week 1, 2, 3 and Week 4. |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At baseline and at Week 6 and Week 8. |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline and at Week 1, 2 and Week 3. |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At baseline and at Week 6 and Week 8. |
| Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At week 1, 2, 3 and week 4. |
| Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At week 6 and week 8. |
| Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At week 1, 2, 3 and week 4. |
| Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At week 6 and week 8. |
| Percentage of Patients Reaching Remission at Week 8 | Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8. The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At week 8. |
| Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?". The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | At baseline and at week 1, 2, 3 and week 4. |
| Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?". The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test. | At week 6 and week 8. |
| Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: "Compared to the patients condition at admission, how much has he or she changed?". The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | At week 1, 2, 3 and week 4. |
| Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: "Compared to the patients condition as admission, how much has he or she changed?". The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At week 6 and week 8. |
| Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | At week 1, 2, 3 and week 4. |
| Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At week 6 and week 8. |
| Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4 | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline and at week 4. |
| Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At baseline and at week 8. |
| Reason for Living (RFL) Questionaire at Baseline | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome). Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline. |
| Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome). Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | At baseline and at week 8. |
| Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with concomitant medication for anxiety and sleep taken at different timepoints. V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10. |
| Number of Patients With Treatment Emergent Adverse Event | Number of patients with any adverse event occuring during on-treatment phase. Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | From start of treatment until 3 days after end of treatment, up to 120 days. |
| Change From Baseline in Blood Pressure to Week 4 and Week 8 | Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline, at week 4 and week 8. |
| Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline in weight to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | At baseline, at week 4 and week 8. |
| Number of Patients With Potentially Clinically Significant Laboratory Findings | Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Up to week 8. |
| Number of Patients Withdrawn Due to Adverse Events | Number of patients withdrawn due to adverse events. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | From start of treatment until 3 days after end of treatment, up to 120 days. |
| Lost to Follow-up |
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| Protocol Violation |
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| Lack of Efficacy |
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| Adverse Event |
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| Not treated |
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| BG001 | 120 mg Duloxetine | From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Investigator Country | Count of Participants | Participants |
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| Montgomery-Asberg Depression Rating Scale (MADRS) total score | The MADRS total score is used to measure the severity of depression. It is based on 10 items ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Values are measured at baseline. TRS. | Mean | Standard Deviation | score on scale |
|
| OG000 |
| 60 mg Duloxetine |
1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). |
| OG001 | 120 mg Duloxetine | From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). |
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| Secondary | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at Week 1, 2, 3 and Week 4. |
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| Secondary | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at Week 6 and Week 8. |
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| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at Week 1, 2 and Week 3. |
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|
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| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at Week 6 and Week 8. |
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|
| Secondary | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment-regimen. | Posted | Number | Percentage of Participants | At week 1, 2, 3 and week 4. |
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|
| Secondary | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Posted | Number | Percentage of Participants | At week 6 and week 8. |
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| Secondary | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Number | Percentage of Participants | At week 1, 2, 3 and week 4. |
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| Secondary | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Posted | Number | Percentage of participants | At week 6 and week 8. |
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| Secondary | Percentage of Patients Reaching Remission at Week 8 | Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8. The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Posted | Number | Percentage of participants | At week 8. |
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| Secondary | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?". The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Count of Participants | Participants | At baseline and at week 1, 2, 3 and week 4. |
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| Secondary | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?". The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Posted | Count of Participants | Participants | At week 6 and week 8. |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: "Compared to the patients condition at admission, how much has he or she changed?". The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Count of Participants | Participants | At week 1, 2, 3 and week 4. |
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|
|
| Secondary | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: "Compared to the patients condition as admission, how much has he or she changed?". The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment group. | Posted | Count of Participants | Participants | At week 6 and week 8. |
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| Secondary | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Posted | Count of Participants | Participants | At week 1, 2, 3 and week 4. |
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|
|
| Secondary | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Posted | Count of Participants | Participants | At week 6 and week 8. |
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| Secondary | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4 | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Treatment regimen. | Posted | Mean | Standard Deviation | Units on a score | At baseline and at week 4. |
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| Secondary | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Post-week 4 treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at week 8. |
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| Secondary | Reason for Living (RFL) Questionaire at Baseline | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome). Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Treatment regimen. | Posted | Mean | Standard Deviation | Score on a scale | At baseline. |
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| Secondary | Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome). Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. | Only participants included in the FAS and with non-missing values for this endpoint were included in the analysis. Post-week 4 treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at week 8. |
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| Secondary | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with concomitant medication for anxiety and sleep taken at different timepoints. V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Only participants included in the treated set and with non-missing values for this endpoint were included in the analysis. Treatment regimen. | Posted | Count of Participants | Participants | 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10. |
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| Secondary | Number of Patients With Treatment Emergent Adverse Event | Number of patients with any adverse event occuring during on-treatment phase. Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Treatment regimen. | Posted | Count of Participants | Participants | From start of treatment until 3 days after end of treatment, up to 120 days. |
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| Secondary | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Treated Set (TRS): All randomised patients treated with at least one dose of study medication. Patients randomised but not treated with at least one dose of study drug were excluded, as they cannot contribute information on the drug effect. Only patients with non-missing data for this endpoint were included. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | At baseline, at week 4 and week 8. |
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| Secondary | Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline in weight to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Treated Set (TRS): All randomised patients treated with at least one dose of study medication. Patients randomised but not treated with at least one dose of study drug were excluded, as they cannot contribute information on the drug effect. Only patients with non-missing data for this endpoint were included. | Posted | Mean | Standard Deviation | Kilogram (kg) | At baseline, at week 4 and week 8. |
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| Secondary | Number of Patients With Potentially Clinically Significant Laboratory Findings | Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Only participants included in the treated set (TRS) and with non-missing values for each laboratory parameter. | Posted | Count of Participants | Participants | Up to week 8. |
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| Secondary | Number of Patients Withdrawn Due to Adverse Events | Number of patients withdrawn due to adverse events. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). | Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Treatment regimen. | Posted | Count of Participants | Participants | From start of treatment until 3 days after end of treatment, up to 120 days. |
|
|
|
| 0 |
| 167 |
| 6 |
| 167 |
| 67 |
| 167 |
| EG001 | 120 mg Duloxetine | From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). | 0 | 171 | 6 | 171 | 54 | 171 |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Serotonin syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D006571 |
| Heterocyclic Compounds |
| Change from baseline to week 3 |
|
| Change from baseline to week 4 |
|
|
| Change from baseline to week 8 |
|
|
| <0.0001 |
| Other |
| Within-group comparison, week 8 versus baseline. | Singed Rank test | <0.0001 | Other |
| Within-group comparison, week 8 versus baseline. | Signed Rank test | <0.0001 | Other |
| Change from baseline to Week 3 |
|
|
| Change from baseline to week 8 |
|
|
| <0.0001 |
| Other |
| Within group comparisons were performed at week 8 versus baseline. | McNemar | <0.0001 | Other |
| Within group comparisons were performed at week 8 versus baseline. | McNemar | <0.0001 | Other |
| Week 3 |
|
| Week 4 |
|
| Week 8 |
|
| Week 3 |
|
| Week 4 |
|
| Week 8 |
|
| Yes |
|
| Mildly ill |
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| Most extremely ill |
|
| Week 1 |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
| Borderline ill |
|
| Mildly ill |
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| Most extremely ill |
|
| Week 8 |
|
| Signed Rank test |
| <0.0001 |
| Statistic |
| -540 |
Difference is value at week 8 minus week 4. |
| Other |
| At week 8, within-group comparison versus week 4 was performed. | Signed Rank test | <0.0001 | Statistic | -1024.5 | Difference is value at week 8 minus week 4. | Other |
| At week 8, within-group comparison versus week 4 was performed. | Signed Rank test | <0.0001 | Statistic | -279 | Difference is value at week 8 minus week 4. | Other |
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
| Much improved |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Week 8 |
|
| Much better |
|
| A little better |
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
| Very much better |
|
| Much better |
|
| A little better |
|
| No change |
|
| A little worse |
|
| Much worse |
|
| Very much worse |
|
| Week 8 |
|
| <0.0001 |
| Other |
| Within-group comparison, week 8 versus baseline. | Student statistic t-test | <0.0001 | Other |
| Within-group comparison, week 8 versus baseline. | Student statistic t-test | <0.0001 | Other |
| 0.001 |
| Other |
| Within-group comparison, week 8 versus baseline. | Student statistic t-test | <0.0001 | Other |
| Within-group comparison, week 8 versus baseline. | Student statistic t-test | 0.28 | Other |
| Number of patients with medication taken between V2 - V3 |
|
| Patients with medication taken between V3 - V4 |
|
| Number of patients with medication taken between V4 - V5 |
|
| Number of patients with medication taken between V5 - V6 |
|
| Number of patients with medication taken between V6 - V7 |
|
| Number of patients with medication taken between V7 - V8 |
|
| Number of patients with medication taken after V8 (week 10) |
|
| Number of patients with medication not taken between two consecutive visits |
|
| Systolic BP: Change from baseline to week 8 |
|
|
| Diastolic BP: Change from baseline to week 4. |
|
|
| Diastolic BP: Change from baseline to week 8 |
|
|
| Change from baseline to week 8 |
|
|
| Haenatocrit Increase |
|
|
| Red blood cell ct. Decrease |
|
|
| Red blood cell ct. Increase |
|
|
| MCV Decrease |
|
|
| MCV Increase |
|
|
| MCHC Decrease |
|
|
| MCHC Increase |
|
|
| White blood cell ct. Decrease |
|
|
| White blood cell ct. Increase |
|
|
| Platelets Decrease |
|
|
| Platelets Increase |
|
|
| Eosinophils Decrease |
|
|
| Eosinophils Increase |
|
|
| Basophils Decrease |
|
|
| Basophils Increase |
|
|
| Lymphocytes Decrease |
|
|
| Lymphocytes Increase |
|
|
| Monocytes Decrease |
|
|
| Monocytes Increase |
|
|
| Neut., bands (stabs) Decrease |
|
|
| Neut., bands (stabs) Increase |
|
|
| Sodium Decrease |
|
|
| Sodium Increase |
|
|
| Potassium Decrease |
|
|
| Potassium Increase |
|
|
| Calcium Decrease |
|
|
| Calcium Increase |
|
|
| Chloride Decrease |
|
|
| Chloride Increase |
|
|
| Phosphate Decrease |
|
|
| Phosphate Increase |
|
|
| Bicarbonate Decrease |
|
|
| Bicarbonate Increase |
|
|
| AST/GOT, SGOT Decrease |
|
|
| AST/GOT, SGOT Increase |
|
|
| ALT/GPT, SGPT Decrease |
|
|
| ALT/GPT, SGPT Increase |
|
|
| Alkaline phosphatase Decrease |
|
|
| Alkaline phosphatase Increase |
|
|
| GGT Decrease |
|
|
| GGT Increase |
|
|
| Creatine kinase Decrease |
|
|
| Creatine kinase Increase |
|
|