Trial Outcomes & Findings for Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients (NCT NCT00474708)
NCT ID: NCT00474708
Last Updated: 2012-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1151 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-03-05
Participant Flow
Participants were recruited in China from March 2007 to January 2008.
There was no screening period for this study. Screening was done by the investigator.
Participant milestones
| Measure |
Venlafaxine XR
75-225 mg per day
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
791
|
367
|
|
Overall Study
COMPLETED
|
734
|
342
|
|
Overall Study
NOT COMPLETED
|
57
|
25
|
Reasons for withdrawal
| Measure |
Venlafaxine XR
75-225 mg per day
|
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.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
11
|
5
|
|
Overall Study
Suicide ideation/behavior
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
|
Overall Study
Lack of compliance
|
12
|
4
|
|
Overall Study
Lost to Follow-up
|
18
|
9
|
|
Overall Study
Physician Decision
|
9
|
6
|
Baseline Characteristics
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
Baseline characteristics by cohort
| Measure |
Venlafaxine XR
n=787 Participants
75-225 mg per day
|
SSRI or Conventional Antidepressant Group
n=364 Participants
Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
|
Total
n=1151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.97 years
STANDARD_DEVIATION 12.84 • n=93 Participants
|
40.49 years
STANDARD_DEVIATION 13.08 • n=4 Participants
|
40.13 years
STANDARD_DEVIATION 12.92 • n=27 Participants
|
|
Sex: Female, Male
Female
|
460 Participants
n=93 Participants
|
225 Participants
n=4 Participants
|
685.0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=93 Participants
|
139 Participants
n=4 Participants
|
466.0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Venlafaxine XR
n=664 Participants
75-225 mg per day
|
SSRI or Conventional Antidepressant Group
n=295 Participants
Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
|
|---|---|---|
|
Number of Patients Achieving Remission
|
554 participants
|
207 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Venlafaxine XR
n=664 Participants
75-225 mg per day
|
SSRI or Conventional Antidepressant Group
n=295 Participants
Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
|
|---|---|---|
|
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Co-morbid anxiety disorder
|
60 participants
|
23 participants
|
|
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
No anxiety disorder
|
494 participants
|
184 participants
|
Adverse Events
Venlafaxine XR
Serious events: 3 serious events
Other events: 418 other events
Deaths: 0 deaths
SSRI or Conventional Antidepressant Group
Serious events: 1 serious events
Other events: 236 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venlafaxine XR
75-225 mg per day
|
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.
|
|---|---|---|
|
Psychiatric disorders
Attempted suicide
|
0.13%
1/787
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Pregnancy
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Hospitalization
|
0.13%
1/787
|
0.27%
1/365
|
Other adverse events
| Measure |
Venlafaxine XR
75-225 mg per day
|
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.4%
66/787
|
11.8%
43/365
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.13%
1/787
|
0.00%
0/365
|
|
Gastrointestinal disorders
Nausea
|
8.3%
65/787
|
12.9%
47/365
|
|
Gastrointestinal disorders
Diarrhea
|
0.89%
7/787
|
1.6%
6/365
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
48/787
|
6.6%
24/365
|
|
Gastrointestinal disorders
Bitter taste
|
0.38%
3/787
|
0.00%
0/365
|
|
Gastrointestinal disorders
No appetite
|
0.25%
2/787
|
1.1%
4/365
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
8/787
|
0.55%
2/365
|
|
Gastrointestinal disorders
Stomach disorder
|
0.51%
4/787
|
0.27%
1/365
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.25%
2/787
|
1.6%
6/365
|
|
Gastrointestinal disorders
Gastrointestinal reaction
|
0.38%
3/787
|
0.00%
0/365
|
|
Gastrointestinal disorders
Flatulence
|
0.89%
7/787
|
1.9%
7/365
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/787
|
0.27%
1/365
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
2/787
|
0.00%
0/365
|
|
Gastrointestinal disorders
Anorexia
|
0.51%
4/787
|
1.4%
5/365
|
|
Nervous system disorders
Anesthesia local
|
0.13%
1/787
|
0.00%
0/365
|
|
Nervous system disorders
Dizziness
|
5.1%
40/787
|
3.6%
13/365
|
|
Nervous system disorders
Vertigo
|
0.25%
2/787
|
0.00%
0/365
|
|
Nervous system disorders
Tremor
|
0.25%
2/787
|
0.27%
1/365
|
|
Nervous system disorders
Night sweats
|
0.38%
3/787
|
0.00%
0/365
|
|
Nervous system disorders
Sweating increased
|
1.3%
10/787
|
1.9%
7/365
|
|
Psychiatric disorders
Sluggish
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Dreaminess
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Fidget
|
0.13%
1/787
|
0.27%
1/365
|
|
Psychiatric disorders
Anxiety
|
0.25%
2/787
|
1.9%
7/365
|
|
Psychiatric disorders
Insomina
|
0.89%
7/787
|
2.2%
8/365
|
|
Psychiatric disorders
Somnolence
|
0.76%
6/787
|
0.82%
3/365
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/787
|
0.27%
1/365
|
|
Psychiatric disorders
Sexual dysfunction
|
0.13%
1/787
|
0.55%
2/365
|
|
Psychiatric disorders
Sexual hypoesthesia
|
0.25%
2/787
|
1.9%
7/365
|
|
Psychiatric disorders
Drug abuse
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Irritability
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Manic
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Switching
|
0.13%
1/787
|
0.55%
2/365
|
|
Psychiatric disorders
Suicide
|
0.13%
1/787
|
0.00%
0/365
|
|
Psychiatric disorders
Dreaming abnormal
|
0.13%
1/787
|
0.00%
0/365
|
|
General disorders
Fever
|
0.13%
1/787
|
0.00%
0/365
|
|
General disorders
Feeble
|
0.89%
7/787
|
0.27%
1/365
|
|
General disorders
Abdominal disorder
|
0.13%
1/787
|
0.00%
0/365
|
|
General disorders
Muscular soreness
|
0.00%
0/787
|
0.27%
1/365
|
|
General disorders
Fatigue
|
1.3%
10/787
|
0.82%
3/365
|
|
General disorders
General malaise
|
0.13%
1/787
|
0.00%
0/365
|
|
General disorders
Head malaise
|
0.25%
2/787
|
0.00%
0/365
|
|
General disorders
Headache
|
2.7%
21/787
|
0.00%
0/365
|
|
General disorders
Chest pain
|
0.13%
1/787
|
0.00%
0/365
|
|
General disorders
Waist disorder
|
0.13%
1/787
|
0.00%
0/365
|
|
Cardiac disorders
Hypertension
|
0.38%
3/787
|
0.27%
1/365
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/787
|
0.27%
1/365
|
|
Cardiac disorders
Palpitations
|
1.5%
12/787
|
1.4%
5/365
|
|
Cardiac disorders
Unstable blood pressure
|
0.13%
1/787
|
0.00%
0/365
|
|
Metabolism and nutrition disorders
Hyperlipaemia
|
0.51%
4/787
|
0.55%
2/365
|
|
Metabolism and nutrition disorders
Thirst
|
0.00%
0/787
|
0.27%
1/365
|
|
Metabolism and nutrition disorders
Weight increase
|
0.13%
1/787
|
1.6%
6/365
|
|
Metabolism and nutrition disorders
Weight decrease
|
0.64%
5/787
|
0.00%
0/365
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.25%
2/787
|
1.9%
7/365
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
4/787
|
1.1%
4/365
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.51%
4/787
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Pregnancy
|
0.13%
1/787
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Oligiomenorrhea
|
0.25%
2/787
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.13%
1/787
|
0.00%
0/365
|
|
Renal and urinary disorders
Micturition frequency
|
0.38%
3/787
|
0.00%
0/365
|
|
Renal and urinary disorders
Dysuria
|
0.25%
2/787
|
0.27%
1/365
|
|
Renal and urinary disorders
Micturition disorder
|
0.13%
1/787
|
0.00%
0/365
|
|
Eye disorders
Visual abnormal
|
0.38%
3/787
|
0.00%
0/365
|
|
Eye disorders
Eye disorder
|
0.25%
2/787
|
0.00%
0/365
|
|
Eye disorders
Dry eye
|
0.25%
2/787
|
0.00%
0/365
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/787
|
0.55%
2/365
|
|
Musculoskeletal and connective tissue disorders
Muscel spasm
|
0.13%
1/787
|
0.00%
0/365
|
|
Musculoskeletal and connective tissue disorders
Waist pain
|
0.25%
2/787
|
0.00%
0/365
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
4/787
|
0.00%
0/365
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.38%
3/787
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.25%
2/787
|
0.27%
1/365
|
|
Ear and labyrinth disorders
Tinnitus
|
0.13%
1/787
|
0.55%
2/365
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER