Effects of once-daily extended release quetiapine fumarate on patient-reported outcomes in patients with generalized anxiety disorder

Figures & data

Figure 1 Schedule for study treatments in (A) acute studies and (B) maintenance study.

Notes: (A) ^aEnrollment was a maximum of 28 days prior to randomization; ^bD1448C00009 and D1448C00011 only; ^cD1448C00009 and D1448C00010 only; down-titration in D1448C00009 only; ^dD1448C00010 only; ^eD1448C00011 only. (B) ^aTitration: Days 1–2 50 mg/day, Day 3 onwards 150 mg/day; ^btitration: Days 1–2 50 mg/day, Days 3–4 150 mg/day, Day 5 onwards 300 mg/day; ^cmaximum, or until anxiety event, or cessation of the study.

© Wolters Kluwer Health; reproduced with kind permission from Khan et al²¹ and Katzman et al²⁵ respectively.

Abbreviations: CGI-S, Clinical Global impressions-Severity of illness; HAM-A, Hamilton Rating Scale for Anxiety; MADRS, Montgomery Åsberg Depression Rating Scale; XR, extended release.

Table 1 Demographics and scores at randomization for HAM-A total and patient-reported outcome measures (pooled modified intent-to-treat population [acute studies] and intent-to-treat population [maintenance study])

	Pooled acute studiesa				Maintenance studyb
	Placebo (n = 654)	Quetiapine XR 50 mg/day (n = 438)	Quetiapine XR 150 mg/day (n = 654)	Quetiapine XR 300 mg/day (n = 425)	Placeboc (n = 216)	Quetiapine XRd 50–300 mg/day (n = 216)
Gender, n (%)
Male	236 (36.1)	164 (37.4)	225 (34.4)	146 (34.4)	79 (36.6)	71 (32.9)
Female	418 (63.9)	274 (62.6)	429 (65.6)	279 (65.6)	137 (63.4)	145 (67.1)
Age, years
Mean ± SD	39.0 ± 12.4	39.9 ± 11.7	40.4 ± 12.0	40.0 ± 12.3	41.7 ± 12.2	44.8 ± 11.0
Time since first diagnosis of GAD, years
Mean ± SD	4.8 ± 6.8	4.5 ± 6.1	4.5 ± 6.0	5.6 ± 7.4	5.3 ± 7.8	5.2 ± 7.1
Rating scale scores, mean (SD)
HAM-A total	25.8 ± 4.3	25.8 ± 4.2	25.4 ± 4.1	24.8 ± 3.7	6.2 ± 3.2	5.9 ± 3.3
Q-LES-Q-SF % maximum total	51.0 ± 15.4	50.1 ± 14.0	51.1 ± 14.8	53.6 ± 14.5	68.2 ± 14.3	68.6 ± 14.3
Q-LES-Q-SF % item 15 (satisfaction with medication)	3.4 ± 1.0	3.4 ± 0.9	3.5 ± 0.9	3.7 ± 0.9	3.9 ± 0.7	4.1 ± 0.6
Q-LES-Q-SF % item 16 (overall life satisfaction)	2.8 ± 0.9	2.8 ± 0.9	2.8 ± 0.9	3.0 ± 0.8	3.7 ± 0.8	3.8 ± 0.7
PSQI global score	11.0 ± 3.7	10.4 ± 3.7	10.7 ± 3.8	11.0 ± 3.6	5.3 ± 3.5	5.3 ± 3.2
Sleep quality	1.9 ± 0.8	1.8 ± 0.7	1.8 ± 0.8	1.9 ± 0.8	0.7 ± 0.7	0.6 ± 0.6
Sleep latency	2.1 ± 1.0	2.0 ± 1.0	2.0 ± 1.0	2.1 ± 1.0	1.0 ± 0.9	1.0 ± 0.9
Sleep duration	1.5 ± 0.9	1.3 ± 0.9	1.4 ± 1.0	1.5 ± 1.0	0.5 ± 0.7	0.6 ± 0.7
Habitual sleep efficiency	1.4 ± 1.3	1.4 ± 1.2	1.4 ± 1.3	1.5 ± 1.3	0.7 ± 1.2	0.6 ± 1.0
Sleep disturbances	1.8 ± 0.6	1.7 ± 0.6	1.7 ± 0.6	1.7 ± 0.6	1.1 ± 0.5	1.2 ± 0.5
Use of sleep medication	0.7 ± 1.1	0.6 ± 1.0	0.7 ± 1.1	0.7 ± 1.1	0.3 ± 0.9	0.3 ± 0.9
Daytime dysfunction	1.6 ± 0.8	1.6 ± 0.8	1.6 ± 0.8	1.6 ± 0.8	1.0 ± 0.7	0.9 ± 0.7
SDS total score	NR	NR	NR	NR	6.4 ± 6.2	5.9 ± 6.0
Work/school	NR	NR	NR	NR	2.2 ± 2.1	2.0 ± 2.1
Social life	NR	NR	NR	NR	2.2 ± 2.2	1.9 ± 2.1
Family life/home responsibilities	NR	NR	NR	NR	2.1 ± 2.3	2.0 ± 2.1
Unproductive days	NR	NR	NR	NR	0.3 ± 0.9	0.2 ± 0.8
Underproductive days	NR	NR	NR	NR	0.8 ± 1.5	0.7 ± 1.4

Notes:

a Pooled acute studies, D1448C00009, D1448C00010, and D1448C00011;

b maintenance study, D1448C00012;

c patients who received quetiapine XR in the open-label period and went on to receive placebo in the randomized period;

d patients who received quetiapine XR in both the open-label and randomized periods.

Abbreviations: GAD, generalized anxiety disorder; HAM-A, Hamilton Rating Scale for Anxiety; NR, not recorded; PSQI, Pittsburgh Sleep Quality Index; Q-LES-Q-SF, Quality of Life and Satisfaction Questionnaire short form; SD, standard deviation; SDS, Sheehan Disability Scale; XR, extended release.

Figure 2 Least squares mean change from randomization in Quality of Life and Satisfaction Questionnaire short form scores at (A) week 8 in pooled acute studies (modified intent-to-treat; last observation carried forward) and (B) during randomized treatment in the maintenance study (intent-to-treat; last observation carried forward).

Notes: (A) *P < 0.05; ***P < 0.001 vs placebo. n = placebo, quetiapine XR 50, 150 and 300 mg/day, respectively. (B) *P < 0.05; **P < 0.01; ***P < 0.001 vs placebo. n = placebo and quetiapine XR, respectively.

Abbreviations: ITT, intent-to-treat; LSM, least squares mean; XR, extended release.

Figure 3 Least squares mean change from randomization in Pittsburgh Sleep Quality Index score at (A) week 8 in pooled acute studies (modified intentto- treat; last observation carried forward) and (B) during randomized treatment in the maintenance study (intent-to-treat; last observation carried forward).

Notes: (A) *P < 0.05; ***P < 0.001 vs placebo. n = placebo, quetiapine XR 50, 150, and 300 mg/day, respectively. (B) ***P < 0.001 vs placebo. n = placebo, quetiapine XR, respectively.
Abbreviations: ITT, intent-to-treat; LSM, least squares mean; PSQI, Pittsburgh Sleep Quality Index; XR, extended release.

Figure 4 Least squares mean change from randomization in Sheehan Disability Scale score during randomized treatment in the maintenance study (intent-to-treat; last observation carried forward).

Notes: *P < 0.05 vs placebo. n = placebo and quetiapine XR, respectively.

Abbreviations: ITT, intent-to-treat; LSM, least squares mean; SDS, Sheehan Disability Scale; XR, extended release.

KhanAJoyceMAtkinsonSEggensIBaldytchevaIErikssonHA randomized, double-blind study of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorderJ Clin Psychopharmacol201131441842821694613

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KatzmanMABrawman-MintzerOReyesEBOlaussonBLiuSErikssonHExtended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trialInt Clin Psychopharmacol2011261112420881846

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