Factors impacting the efficacy of venlafaxine extended release 75–225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan

Figures & data

Figure 1 Forest plot of the HAM-D₁₇ total score by subgroups: difference between venlafaxine ER treatment group and the placebo group in the adjusted mean change from baseline at Week 8 with 95% CIs (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MDD, major depressive disorder.

Figure 2 Forest plot of the HAM-D₆ score by subgroups: difference between venlafaxine ER treatment group and the placebo group in the adjusted mean change from baseline at Week 8 with 95% CIs (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MDD, major depressive disorder.

Figure 3 Forest plot of the MADRS total score by subgroups: difference between venlafaxine ER treatment group and the placebo group in the adjusted mean change from baseline at Week 8 with 95% CIs (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale; MDD, major depressive disorder.

Figure 4 Adjusted mean change from baseline at Week 8 with 95% CIs by duration of MDD (≤22 months/>22 months) in each efficacy endpoint (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale; MDD, major depressive disorder.

Figure 5 Adjusted mean change from baseline in each efficacy endpoint at Week 8 with 95% CIs by duration of MDD (A) <12 months/≥12 months, and (B) <48 months/≥48 months (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale; MDD, major depressive disorder.

Table 1 Demographic and disease characteristics by duration of MDD (≤22 months/>22 months) (FAS)

	Duration of MDD (months)
	≤22 months (n=267)		>22 months (n=268)
Sex	Male	Female	Male	Female
Placebo	43 (48.9)	45 (51.1)	48 (50.0)	48 (50.0)
Venlafaxine ER 75 mg/day	48 (50.0)	48 (50.0)	36 (46.2)	42 (53.8)
Venlafaxine ER 75–225 mg/day	41 (49.4)	42 (50.6)	51 (54.3)	43 (45.7)
Age, years
Placebo	39.2 (12.0)		38.0 (10.2)
Venlafaxine ER 75 mg/day	37.8 (12.6)		39.2 (10.8)
Venlafaxine ER 75–225 mg/day	38.0 (10.3)		38.4 (10.3)
Weight, kg
Placebo	62.6 (17.2)		60.8 (14.8)
Venlafaxine ER 75 mg/day	61.4 (14.1)		62.2 (14.7)
Venlafaxine ER 75–225 mg/day	60.8 (12.9)		63.7 (15.5)
BMI, kg/m^2
Placebo	22.8 (4.5)		22.2 (4.0)
Venlafaxine ER 75 mg/day	22.3 (4.1)		23.1 (4.6)
Venlafaxine ER 75–225 mg/day	22.6 (4.0)		23.5 (4.7)
Duration of MDD, months
Placebo	9.8 (5.2)		75.7 (50.1)
Venlafaxine ER 75 mg/day	9.3 (5.2)		78.5 (53.9)
Venlafaxine ER 75–225 mg/day	7.9 (4.0)		89.7 (64.3)
Duration of the current depressive episode, months
Placebo	8.1 (4.8)		14.1 (18.7)
Venlafaxine ER 75 mg/day	7.9 (4.8)		17.3 (24.2)
Venlafaxine ER 75–225 mg/day	7.3 (4.0)		16.3 (22.3)
Number of previous depressive episodes
Placebo	0.2 (0.4)		1.3 (1.0)
Venlafaxine ER 75 mg/day	0.1 (0.3)		1.6 (1.7)
Venlafaxine ER 75–225 mg/day	0.1 (0.2)		1.4 (1.4)
Baseline HAM-D17 total score
Placebo	22.0 (3.5)		22.8 (4.6)
Venlafaxine ER 75 mg/day	22.8 (3.8)		22.5 (4.3)
Venlafaxine ER 75–225 mg/day	22.4 (3.9)		22.3 (4.1)
Baseline MADRS total score
Placebo	32.8 (4.9)		33.5 (5.3)
Venlafaxine ER 75 mg/day	32.6 (4.2)		32.7 (4.7)
Venlafaxine ER 75–225 mg/day	32.5 (4.7)		33.0 (4.8)

Notes: Sex is described as number of patients (%); all other parameters are described as mean (SD).

Abbreviations: BMI, body mass index; FAS, full analysis set; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; MADRS, Montgomery–Asberg Depression Rating Scale; MDD, major depressive disorder.

Figure 6 Adjusted mean change from baseline at Week 8 with 95% CIs by HAM-D₁₇ total score at baseline (total score ≤22/total score >22) in each efficacy endpoint (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale.

Figure 7 Adjusted mean change from baseline at Week 8 with 95% CIs by history of previous depressive episodes (0 [single episode]/≥1 [recurrent episodes]) in each efficacy endpoint (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale.

Figure 8 Adjusted mean change from baseline at Week 8 with 95% CIs by duration of current depressive episode (≤6.6 months/>6.6 months) in each efficacy endpoint (FAS, LOCF, ANCOVA model).

Abbreviations: FAS, full analysis set; HAM-D₆, Hamilton Rating Scale for Depression–6 items; HAM-D₁₇, Hamilton Rating Scale for Depression–17 items; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale.