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Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine Extended Release | Experimental | Lithium or valproate at stable doses within seric therapeutic levels |
|
| Sertraline | Active Comparator | Lithium or valproate at stable doses within seric therapeutic levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended release quetiapine (quetiapine XR) | Drug | Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | baseline, week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | baseline, week 1 |
| The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Vitoria-Gasteiz | Basque Country | Spain | |||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine Extended Release | Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. |
| FG001 | Setraline | Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine Extended Release | Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. |
| BG001 | Setraline |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 2 |
|
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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 | Quetiapine Extended Release | Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
|
| Sertraline | Drug | Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study. |
|
|
| adequate mood stabilizer | Drug | An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively). |
|
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) |
| baseline, week 4 |
| The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | baseline. week 8 |
| The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | baseline, week 1 |
| The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | baseline, week 2 |
| The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | baseline, week 4 |
| The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) | baseline, week 8 |
| The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) | baseline, week 4 |
| The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) | baseline, week 8 |
| Number of Patients Response at Week 1 | Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 1 |
| Number of Patients With Response at Week 2 | Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 2 |
| Number of Patients With Response at Week 4. | Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 4 |
| Number of Patients With Response at Week 8. | Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 8 |
| Number of Patients With Remission at Week 1. | Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 1 |
| Number of Patients With Remission at Week 2. | Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 2 |
| Number of Patients With Remission at Week 4. | Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 4 |
| Number of Patients With Remission at Week 8. | Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | week 8 |
| Santander |
| Cantabria |
| Spain |
| Research Site | Zamora | Castille and León | Spain |
| Research Site | Vigo | Galicia | Spain |
| Physician Decision |
|
Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Montgomery Asberg Depression Rating Scale (MADRS) total score, Continuous | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | Mean | Standard Deviation | score on a scale |
|
| Clinical Impression Global Scale - Bipolar total score (CGI-BP-M), Continuous | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) | Mean | Standard Deviation | score on a scale |
|
| Hamilton Anxiety Rating Scale (HARS) total score, Continuous | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) | Mean | Standard Deviation | score on a scale |
|
| OG001 | Setraline | Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. |
|
|
| Secondary | The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 1 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline. week 8 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 1 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 2 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 8 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 4 |
|
|
|
| Secondary | The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, week 8 |
|
|
|
| Secondary | Number of Patients Response at Week 1 | Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 1 |
|
|
|
| Secondary | Number of Patients With Response at Week 2 | Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 2 |
|
|
|
| Secondary | Number of Patients With Response at Week 4. | Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 4 |
|
|
|
| Secondary | Number of Patients With Response at Week 8. | Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 8 |
|
|
|
| Secondary | Number of Patients With Remission at Week 1. | Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 1 |
|
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| Secondary | Number of Patients With Remission at Week 2. | Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 2 |
|
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|
| Secondary | Number of Patients With Remission at Week 4. | Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. | Posted | Number | Participants | week 4 |
|
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| Secondary | Number of Patients With Remission at Week 8. | Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. | Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology | Posted | Number | Participants | week 8 |
|
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|
| 0 |
| 14 |
| 12 |
| 14 |
| EG001 | Setraline | Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. | 0 | 13 | 9 | 13 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased libido | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |