Background
Methods
Study design
Study population
Inclusion criteria
Exclusion criteria
Treatment protocol
Efficacy and safety assessments
Statistical analysis
Results
Patients
Characteristic | Placebo | Desvenlafaxine | Desvenlafaxine |
---|---|---|---|
(n = 223) | 10 mg/d (n = 226) | 50 mg/d (n = 224) | |
Age, y
| 42 ± 13 | 41 ± 14 | 43 ± 14 |
Age group, n (%)
| |||
18-64 y | 215 (96) | 212 (94) | 213 (95) |
>64 y | 8 (4) | 14 (6) | 11 (5) |
Female, n (%)
| 139 (62) | 135 (60) | 135 (60) |
Race, n (%)
| |||
White | 176 (79) | 199 (88) | 177 (79) |
Black | 38 (17) | 20 (9) | 37 (17) |
Asian | 4 (2) | 3 (1) | 2 (1) |
Other | 5 (2) | 4 (2) | 8 (4) |
Weight, kg
| 87 ± 24 | 88 ± 27 | 91 ± 26 |
Body mass index, kg/m
2
| 30 ± 7 | 31 ± 9 | 32 ± 8 |
Baseline HAM-D
17
score
| 23 ± 3 | 23 ± 2 | 23 ± 3 |
Duration of current depressive episode, mo
| 34 ± 81 | 26 ± 48 | 31 ± 76 |
Efficacy evaluation
Adjusted mean (SE) change from baseline | |||
---|---|---|---|
Secondary outcome
|
Placebo
|
Desvenlafaxine 10 mg/d
|
Desvenlafaxine 50 mg/d
|
MADRS total score | –9.87 (0.63) | –11.28 (0.63) | –10.76 (0.63) |
CGI-S total score | –1.08 (0.07) | –1.23 (0.07) | –1.11 (0.07) |
HAM-D6 total score | –4.75 (0.27) | –5.49 (0.27) | –5.19 (0.27) |
SDS total score | –2.63 (0.48) | –4.09 (0.48)†
| –3.78 (0.49) |
SDS Work Studies component | –0.61 (0.17) | –1.10 (0.17)†
| –1.14 (0.17)†
|
SDS Social Life component | –1.08 (0.18) | –1.58 (0.17) †
| –1.36 (0.18) |
SDS Life/Home Responsibilities | –0.98 (0.17) | –1.43 (0.17) | –1.20 (0.17) |
WHO-5 total score | 2.96 (0.36) | 4.51 (0.35)‡
| 3.73 (0.36) |
Safety evaluation
Placebo | Desvenlafaxine | Desvenlafaxine | |
---|---|---|---|
(n=223) | 10 mg/d (n=226) | 50 mg/d (n=224) | |
Any TEAE
| 147 (66) | 155 (69) | 154 (69) |
Gastrointestinal disorders
| |||
Constipation | 5 (2) | 4 (2) | 15 (7) |
Diarrhea | 11 (5) | 14 (6) | 17 (8) |
Dry mouth | 11 (5) | 17 (8) | 20 (9) |
Nausea | 14 (6) | 21 (9) | 32 (14) |
General disorders
| |||
Fatigue | 4 (2) | 7 (3) | 13 (6) |
Infections
| |||
Upper RTI | 11 (5) | 18 (8) | 12 (5) |
Metabolism and nutrition disorders
| |||
Decreased appetite | 8 (4) | 9 (4) | 20 (9) |
Nervous system disorders
| |||
Dizziness | 12 (5) | 9 (4) | 16 (7) |
Headache | 17 (8) | 18 (8) | 16 (7) |
Psychiatric disorders
| |||
Insomnia | 8 (4) | 11 (5) | 15 (7) |