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This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| venlafaxine ER 75 mg/day (fixed dose) | Experimental |
| |
| venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venlafaxine ER 75 mg/day (fixed dose) | Drug | Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Baseline, Week 8 or Early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination | MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 - 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narumi Himawari Clinic | Nagoya | Aichi-ken | 458-0801 | Japan | ||
| Mizuho Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32912597 | Derived | Kato M, Asami Y, Wajsbrot DB, Wang X, Boucher M, Prieto R, Pappadopulos E. Clustering patients by depression symptoms to predict venlafaxine ER antidepressant efficacy: Individual patient data analysis. J Psychiatr Res. 2020 Oct;129:160-167. doi: 10.1016/j.jpsychires.2020.06.011. Epub 2020 Jul 9. | |
| 26513202 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Subjects were confirmed to meet entry criteria at the screening visit, followed by a 2-week screening period. Subjects who continued to meet all study entry criteria at baseline were randomized to 10 weeks of treatment with placebo, venlafaxine ER 75 mg/day Fixed, or venlafaxine ER 75-225 mg/day Flexible in the ratio of 1:1:1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo capsule orally once daily after meal for 8 weeks. |
| FG001 | Venlafaxine 75 mg/Day Fixed | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) | Drug | Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration |
|
| Placebo | Drug | Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration |
|
| Baseline, Week 8 or Early termination |
| Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination | CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Baseline, Week 8 or Early termination |
| Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination | HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Baseline, Week 8 or Early termination |
| Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination | QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Baseline, Week 8 or Early termination |
| Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination | CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. | Baseline, Week 8 or Early termination |
| Nagoya |
| Aichi-ken |
| 467-0806 |
| Japan |
| Nippon Medical School Chiba Hokusoh Hospital | Inzai | Chiba | 270-1694 | Japan |
| Hida Clinic | Nagareyama | Chiba | 270-0163 | Japan |
| Nakamoto Clinic | Noda | Chiba | 278-0033 | Japan |
| Hatsuki Shinryo Clinic | Fukuoka | Fukuoka | 814-0104 | Japan |
| Hatakeyama Clinic | Kitakyushu-shi | Fukuoka | 802-0064 | Japan |
| Shiranui Hospital | Omuta | Fukuoka | 836-0004 | Japan |
| Oka Clinic | Omuta | Fukuoka | 836-0044 | Japan |
| Fujikawa Clinic | Hatsukaichi | Hiroshima | 738-0023 | Japan |
| Hayakawa Clinic | Kure | Hiroshima | 737-0111 | Japan |
| Kawamura Mental Clinic | Sapporo | Hokkaido | 001-0023 | Japan |
| Maruyamapark Mentalclinic | Sapporo | Hokkaido | 064-0820 | Japan |
| Arai Clinic | Amagasaki | Hyōgo | 660-0882 | Japan |
| Takahashi Psychiatric Clinic | Ashiya | Hyōgo | 659-0093 | Japan |
| Tatsuta Clinic | Kobe | Hyōgo | 651-0097 | Japan |
| Ikeuchi Psycho Induced Internal Med.Clinic | Kobe | Hyōgo | 655-0037 | Japan |
| National Hospital Organization Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Medical Corporation Seishinkai Kishiro Mental Clinic | Kawasaki | Kanagawa | 214-0014 | Japan |
| Yutaka Clinic | Sagamihara | Kanagawa | 252-0303 | Japan |
| Azamino Mental Clinic | Yokohama | Kanagawa | 225-0011 | Japan |
| Shioiri Mental Clinic | Yokosuka | Kanagawa | 238-0042 | Japan |
| Yuge Hospital | Kumamoto | Kumamoto | 861-8002 | Japan |
| Kuginuki Clinic | Hirakata | Osaka | 573-0032 | Japan |
| Shibamoto Clinic | Osakasayama-shi | Osaka | 589-0011 | Japan |
| Sakai Mental Clinic | Saitama | Saitama | 330-0062 | Japan |
| Suzuki Hospital | Adachi-ku | Tokyo | 120-0033 | Japan |
| Iidabashi Mental Clinic | Chiyoda-ku | Tokyo | 102-0071 | Japan |
| Tutujigaoka Mental Clinic | Chōfu | Tokyo | 182-0006 | Japan |
| Fuku Clinic | Katsushika-ku | Tokyo | 125-0041 | Japan |
| SAKURAZAKA CLINIC SophyAnce | Minato-ku | Tokyo | 106-0032 | Japan |
| Akasaka Clinic | Minato-ku | Tokyo | 107-0052 | Japan |
| Harikae mental clinic | Nakano-Ku | Tokyo | 164-0001 | Japan |
| Heartcare Ginga Clinic | Nakano-ku | Tokyo | 164-0012 | Japan |
| Sangenjaya Nakamura Mental Clinic | Setagaya-ku | Tokyo | 154-0004 | Japan |
| Komazawa Mental Clinic | Setagaya-ku | Tokyo | 154-0012 | Japan |
| Omotesando Mental Clinic | Shibuya-ku | Tokyo | 150-0001 | Japan |
| Maynds Tower Mental Clinic | Shibuya-ku | Tokyo | 151-0053 | Japan |
| Yoyoginomori Mental Clinic | Shibuyaku | Tokyo | 151-0053 | Japan |
| Meguro sta.East Mental Clinic | Shinagawa-ku | Tokyo | 141-0021 | Japan |
| Himeno Tomomi Clinic | Shinagawa-Ku | Tokyo | 141-0032 | Japan |
| Nishi-Shinjuku Concieria Clinic | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Tamaki Clinic | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Kagurazaka Stress Clinic | Shinjuku-ku | Tokyo | 162-0825 | Japan |
| Tokyo Kosei Nenkin Hospital | Shinjuku-ku | Tokyo | 162-8543 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Himorogi Psychiatric Institute | Toshima-ku | Tokyo | 170-0002 | Japan |
| Sugahara Tenjin Clinic | Fukuoka | 810-0001 | Japan |
| Hiro Mental Clinic Tenjinminami | Fukuoka | 810-0004 | Japan |
| Tenjin Mental Clinic | Fukuoka | 810-0004 | Japan |
| Medical Corporation Shinseikai Kaku Mental Clinic | Fukuoka | 810-0022 | Japan |
| Ange Psychiatric Clinic | Fukuoka | 810-0035 | Japan |
| Stress Care Yoshimura Clinic | Fukuoka | 810-0041 | Japan |
| Kuranari Psychiatry Clinic | Fukuoka | 810-0801 | Japan |
| Akasaka Kato Clinic | Fukuoka | 8100041 | Japan |
| Imato Clinic | Fukuoka | 815-0041 | Japan |
| Tsuji Mental Clinic | Hiroshima | 731-0112 | Japan |
| Medical Corporation Toyokokai Tawara Clinic | Kanagawa | 221-0835 | Japan |
| Sagaarashiyama-Tanaka Clinic | Kyoto | 616-8421 | Japan |
| Kyo Mental Clinic | Nara | 631-0036 | Japan |
| JIN clinic | Osaka | 530-0041 | Japan |
| Misato Ekimae Clinic | Saitama | 341-0018 | Japan |
| Eto Mental Clinic Meguro | Tokyo | 142-0021 | Japan |
| Higuchi T, Kamijima K, Nakagome K, Itamura R, Asami Y, Kuribayashi K, Imaeda T. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan. Int Clin Psychopharmacol. 2016 Jan;31(1):8-19. doi: 10.1097/YIC.0000000000000105. |
| FG002 | Venlafaxine 75-225 mg/Day Flexible | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo capsule orally once daily after meal for 8 weeks. |
| BG001 | Venlafaxine 75 mg/Day Fixed | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. |
| BG002 | Venlafaxine 75-225 mg/Day Flexible | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
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| Secondary | Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination | MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 - 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination | CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
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| Secondary | Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination | HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination | QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination | CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. | Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable. | Posted | Mean | Standard Error | Units on a scale | Baseline, Week 8 or Early termination |
|
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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 | Placebo | Participants received placebo capsule orally once daily after meal for 8 weeks. | 2 | 183 | 98 | 183 | ||
| EG001 | Venlafaxine 75 mg/Day Fixed | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. | 1 | 174 | 112 | 174 | ||
| EG002 | Venlafaxine 75-225 mg/Day Flexible | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. | 1 | 180 | 131 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inuiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| MALE |
|
| ANCOVA |
| 0.106 |
Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate. |
| Mean Difference (Final Values) |
| 1.12 |
| 2-Sided |
| 95 |
| -0.24 |
| 2.48 |
Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group |
| Superiority or Other (legacy) |
| OG002 | Venlafaxine 75-225 mg/Day Flexible | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. |
|
|
|
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. |
|
|
|
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
|
|
|
| OG002 | Venlafaxine 75-225 mg/Day Flexible | Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. |
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Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
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