Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
DRUGEffexor
DRUGSSRI
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Males or females, 18 -65 years of age * Outpatients * Major depressive disorder based on DSM-IV criteria * The baseline score of 17-item HAM-D³17 * Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion * Provide written informed consent * If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study. Main
Exclusion criteria
* Hypersensitivity to venlafaxine; * Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure * Alcohol or drug abuse within the last year * A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline) * Bipolar disorder * For female, known or suspected pregnancy or breast feeding * Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline. * Patients have prior use of venlafaxine or use of venlafaxine for the current episode.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Remission | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | 12 weeks | 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. |
Countries
China
Participant flow
Recruitment details
Participants were recruited in China from March 2007 to January 2008.
Pre-assignment details
There was no screening period for this study. Screening was done by the investigator.
Participants by arm
| Arm | Count |
|---|---|
| Venlafaxine XR 75-225 mg per day | 787 |
| 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. | 364 |
| Total | 1,151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of compliance | 12 | 4 |
| Overall Study | Lack of Efficacy | 11 | 5 |
| Overall Study | Lost to Follow-up | 18 | 9 |
| Overall Study | Physician Decision | 9 | 6 |
| Overall Study | Suicide ideation/behavior | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 0 |
Baseline characteristics
| Characteristic | Venlafaxine XR | SSRI or Conventional Antidepressant Group | Total |
|---|---|---|---|
| Age Continuous | 39.97 years STANDARD_DEVIATION 12.84 | 40.49 years STANDARD_DEVIATION 13.08 | 40.13 years STANDARD_DEVIATION 12.92 |
| Sex: Female, Male Female | 460 Participants | 225 Participants | 685.0 Participants |
| Sex: Female, Male Male | 327 Participants | 139 Participants | 466.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 418 / — | 236 / — |
| serious Total, serious adverse events | 3 / — | 1 / — |
Outcome results
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venlafaxine XR | Number of Patients Achieving Remission | 554 participants |
| SSRI or Conventional Antidepressant Group | Number of Patients Achieving Remission | 207 participants |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Venlafaxine XR | Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | Co-morbid anxiety disorder | 60 participants |
| Venlafaxine XR | Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | No anxiety disorder | 494 participants |
| SSRI or Conventional Antidepressant Group | Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | Co-morbid anxiety disorder | 23 participants |
| SSRI or Conventional Antidepressant Group | Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | No anxiety disorder | 184 participants |