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This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1.Effexor XR Group |
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| 2 | Active Comparator | 2.SSRI or Conventional Antidepressant Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effexor | Drug |
| ||
| SSRI | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Remission | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Beijing Municipality | 100080 | China | |||
There was no screening period for this study. Screening was done by the investigator.
Participants were recruited in China from March 2007 to January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine XR | 75-225 mg per day |
| FG001 | SSRI or Conventional Antidepressant Group | Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 12 weeks |
| Beijing |
| Beijing Municipality |
| 100083 |
| China |
| Beijing | Beijing Municipality | 100096 | China |
| Guangzhou | Guangdong | 510000 | China |
| Guangzhou | Guangdong | 510080 | China |
| Guangzhou | Guangdong | 510150 | China |
| Guangzhou | Guangdong | 510370 | China |
| Zhengzhou | Henan | 450006 | China |
| Wuhan | Hubei | 430022 | China |
| Changsha | Hunan | 410011 | China |
| Nanjing | Jiangsu | 210029 | China |
| Shenyang | Liaoning | 110168 | China |
| Jinan | Shandong | 250014 | China |
| Shanghai | Shanghai Municipality | 200003 | China |
| Shanghai | Shanghai Municipality | 200030 | China |
| Shanghai | Shanghai Municipality | 200080 | China |
| Shanghai | Shanghai Municipality | 200083 | China |
| Shanghai | Shanghai Municipality | 200090 | China |
| Shanghai | Shanghai Municipality | 200124 | China |
| Shanghai | Shanghai Municipality | 201900 | China |
| Xian | Shanxi | 710061 | China |
| Tianjin | Tianjin Municipality | 300350 | China |
| Hangzhou | Zhejiang | 310000 | China |
| Hangzhou | Zhejiang | 310013 | China |
| Huzhou | Zhejiang | 313000 | China |
| Suzhou | Zhejiang | 215008 | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine XR | 75-225 mg per day |
| BG001 | SSRI or Conventional Antidepressant Group | Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Remission | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. | The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. | Posted | Mar 2009 | Number | participants | 12 weeks |
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| Secondary | Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. | The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not. | Posted | Mar 2009 | Number | participants | 12 weeks |
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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 | Venlafaxine XR | 75-225 mg per day | 3 | 418 | ||||
| EG001 | SSRI or Conventional Antidepressant Group | Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg. | 1 | 236 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Attempted suicide | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pregnancy | Reproductive system and breast disorders | Non-systematic Assessment |
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| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Bitter taste | Gastrointestinal disorders | Non-systematic Assessment |
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| No appetite | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Stomach disorder | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrointestinal reaction | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Stomach ache | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
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| Anesthesia local | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Vertigo | Nervous system disorders | Non-systematic Assessment |
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| Tremor | Nervous system disorders | Non-systematic Assessment |
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| Night sweats | Nervous system disorders | Non-systematic Assessment |
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| Sweating increased | Nervous system disorders | Non-systematic Assessment |
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| Sluggish | Psychiatric disorders | Non-systematic Assessment |
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| Dreaminess | Psychiatric disorders | Non-systematic Assessment |
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| Fidget | Psychiatric disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Insomina | Psychiatric disorders | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | Non-systematic Assessment |
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| Sexual dysfunction | Psychiatric disorders | Non-systematic Assessment |
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| Sexual hypoesthesia | Psychiatric disorders | Non-systematic Assessment |
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| Drug abuse | Psychiatric disorders | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | Non-systematic Assessment |
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| Manic | Psychiatric disorders | Non-systematic Assessment |
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| Switching | Psychiatric disorders | Non-systematic Assessment |
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| Suicide | Psychiatric disorders | Non-systematic Assessment |
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| Dreaming abnormal | Psychiatric disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Feeble | General disorders | Non-systematic Assessment |
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| Abdominal disorder | General disorders | Non-systematic Assessment |
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| Muscular soreness | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| General malaise | General disorders | Non-systematic Assessment |
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| Head malaise | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Chest pain | General disorders | Non-systematic Assessment |
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| Waist disorder | General disorders | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Unstable blood pressure | Cardiac disorders | Non-systematic Assessment |
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| Hyperlipaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Thirst | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Weight increase | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Weight decrease | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Leucopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment |
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| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pregnancy | Reproductive system and breast disorders | Non-systematic Assessment |
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| Oligiomenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Menstrual disorder | Reproductive system and breast disorders | Non-systematic Assessment |
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| Micturition frequency | Renal and urinary disorders | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
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| Micturition disorder | Renal and urinary disorders | Non-systematic Assessment |
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| Visual abnormal | Eye disorders | Non-systematic Assessment |
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| Eye disorder | Eye disorders | Non-systematic Assessment |
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| Dry eye | Eye disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscel spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Waist pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ejaculation disorder | Reproductive system and breast disorders | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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365 participants were assessed for safety. Certain demographic data (gender and age) is missing for one participant. Thereby resulting in the participant flow reflecting 364 participants.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
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| Male |
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