Table 2.
Demographic and baseline characteristics (all randomized patients).
| Variable |
All studies
(NCT00839423, NCT00635219, NCT00735709, NCT00672958, NCT00672620) |
|||
|---|---|---|---|---|
| Placebo (n=850) |
Vortioxetine 5 mg (n=861) |
Vortioxetine 10 mg (n=394) |
Total (n=2105) |
|
| Age, years | ||||
| Mean (SD) | 43.3 (12.6) | 43.9 (13.0) | 44.9 (12.9) | 43.8 (12.8) |
| Range | 18-75 | 18-75 | 18-75 | 18-75 |
| Gender, n (%) | ||||
| Male | 333 (39.2) | 306 (35.5) | 141 (35.8) | 780 (37.1) |
| Female | 517 (60.8) | 555 (64.5) | 253 (64.2) | 1325 (62.9) |
| Race (grouped) n (%) | ||||
| Caucasian | 673 (79.2) | 662 (76.9) | 321 (81.5) | 1656 (78.7) |
| Black | 112 (13.2) | 125 (14.5) | 6 (1.5) | 243 (11.5) |
| Asian | 61 (7.2) | 69 (8.0) | 64 (16.2) | 194 (9.2) |
| American | 3 (0.4) | 1 (0.1) | 0 | 4 (0.2) |
| 1 (0.1) | 2 (0.2) | 3 (0.8) | 6 (0.3) | |
| BMI, kg/m 2 | ||||
| Mean (SD) | 28.3 (6.9) | 28.4 (7.5) | 25.5 (4.8) | 27.8 (6.9) |
| No. previous MDEs | ||||
| Mean (SD) | 2.3 (2.6) | 2.4 (3.1) | 1.7 (2.1) | 2.2 (2.7) |
| Range | 0–23 | 0–45 | 0–20 | 0–45 |
| Duration of current MDE, weeks | ||||
| Mean (SD) | 35.5 (57.4) | 40.8 (92.0) | 30.6 (64.3) | 36.8 (74.7) |
| MADRS total score | ||||
| Mean (SD) | 32.3 (4.0) | 32.6 (4.1) | 32.3 (3.7) | 32.4 (4.0) |
| CGI-S score | ||||
| Mean (SD) | 4.8 (0.7) | 4.8 (0.7) | 4.9 (0.7) | 4.8 (0.7) |
| HAM-D, mean (SD) | ||||
| Item 4: Insomnia Early1 | 1.5 (0.7) | 1.5 (0.8) | 1.5 (0.7) | 1.5 (0.8) |
| Item 5: Insomnia Middle2 | 1.5 (0.7) | 1.5 (0.7) | 1.5 (0.7) | 1.5 (0.7) |
| Item 6: Insomnia Late3 | 1.4 (0.8) | 1.3 (0.8) | 1.3 (0.7) | 1.3 (0.8) |
| Item 11: Anxiety Somatic4 | 1.6 (0.8) | 1.6 (0.8) | 1.7 (0.7) | 1.6 (0.8) |
| Item 12: Somatic Symptoms: Gastrointestinal5 |
0.8 (0.6) | 0.8 (0.6) | 0.8 (0.6) | 0.8 (0.6) |
| Item 13: Somatic Symptoms: General6 | 1.6 (0.6) | 1.6 (0.6) | 1.5 (0.6) | 1.6 (0.6) |
| Item 14: Genital Symptoms7 | 1.3 (0.8) | 1.3 (0.8) | 1.2 (0.8) | 1.3 (0.8) |
| Item 16: Loss of Weight8 | 0.3 (0.7) | 0.3 (0.7) | 0.5 (0.7) | 0.4 (0.7) |
| Total score (24 items) | 31.0 (5.5) | 31.5 (5.6) | 31.1 (5.5) | 31.2 (5.5) |
| HAM-A, Mean (SD) | ||||
| Item 7: Somatic Muscular9 | 1.2 (0.9) | 1.2 (0.9) | 1.3 (0.9) | 1.3 (0.9) |
| Item 8: Somatic Sensory10 | 0.8 (0.9) | 0.8 (0.9) | 1.1 (0.9) | 0.9 (0.9) |
| Item 9: Cardiovascular11 | 0.8 (0.9) | 0.7 (0.9) | 1.1 (0.9) | 0.8 (0.9) |
| Item 10: Respiratory12 | 0.7 (0.8) | 0.7 (0.8) | 0.9 (0.9) | 0.7 (0.8) |
| Item 11: Gastrointestinal13 | 1.0 (0.9) | 1.0 (0.9) | 1.3 (0.9) | 1.1 (0.9) |
| Item 12: Genitourinary14 | 1.5 (1.1) | 1.5 (1.0) | 1.5 (1.0) | 1.5 (1.0) |
| Item 13: Autonomic15 | 1.2 (0.9) | 1.1 (0.9) | 1.3 (0.9) | 1.2 (0.9) |
| Total score | 20.4 (6.3) | 20.3 (6.1) | 22.3 (6.6) | 20.7 (6.3) |
Item 4: Insomnia Early = complains of occasional difficulty falling asleep, i.e. more than ½ hour, or complains of nightly difficulty falling asleep;
Item 5: Insomnia Middle = patient complains of being restless and disturbed during the night or waking during the night;
Item 6: Insomnia Late = waking in early hours of the morning but goes back to sleep or unable to fall asleep again if getting out of bed;
Item 11: Anxiety Somatic = physiological concomitants of anxiety, such as gastrointestinal – dry mouth, wind, indigestion, diarrhoea, cramps, belching, cardiovascular (palpitations, headache), respiratory (hyperventilation, sighing, urinary frequency, sweating);
Item 12: Somatic Symptoms – Gastrointestinal = loss of appetite but eating without staff encouragement, heavy feelings in abdomen, difficulty eating without staff urging, requests or requires laxatives or medication for bowels or medication for GI symptoms;
Item 13: Somatic Symptoms – General = heaviness in limbs, back or head, backaches, headache, muscle aches, loss of energy and fatigability;
Item 14: Genital Symptoms = symptoms such as loss of libido or menstrual disturbances;
Item 16: Loss of Weight = probable weight loss associated with present illness or definite (according to patient) weight loss.
HAM-A: 9Item 7: Somatic Muscular = includes weakness, stiffness, soreness merging into real pain, which is more or less diffusely localized in the muscles;
Item 8: Somatic Sensory = includes increased fatigability and weakness merging into real functional disturbances of the senses;
Item 9: Cardiovascular = includes tachycardia, palpitations, oppression, chest pain, throbbing in the blood vessels and feelings of fainting;
Item 10: Respiratory = includes feelings of constriction or contraction in throat or chest, dyspnoea merging into choking sensations and sighing respiration;
Item 11: Gastrointestinal = includes difficulties in swallowing, “sinking” sensation of the stomach, dyspepsia (heartburn or burning sensations in the stomach, abdominal pains related to meals, fullness, nausea and vomiting), abdominal rumbling and diarrhoea;
Item 12: Genitourinary = includes non-organic or psychic symptoms such as frequent or more pressing passing of urine, menstrual irregularities, anorgasmia, dyspareunia, premature ejaculation, loss of erection;
Item 13: Autonomic = includes dryness of mouth, blushing or pallor, sweating and dizziness.