Table 3.

Change in psychopathology, quality of life and global clinical state scores over time

	Time pt.	(n = 20)	(n = 25)	p-value	Group	Time	Group*Time
YMRS	Baseline	5.3(1.0)	6.5(0.8)	0.31	F(1,42)=0.27	F(5,182)=1.2	F(5,182)=2.1
	1 month	6.1(1.0)	3.9 (0.8)*	0.09	P = NS	P = NS	P = NS
	3 months	5.2(1.0)	3.9(0.9)*	0.34
	6 months	3.9(1.1)	6.1(0.9)	0.l1
	9 months	4.0(1.1)	4.1(0.9)*	0.91
	12 months	5.7(1.1)	6.7(1.0)	0.17
MADRS	Baseline	14.4(1.6)	15.6(1.4)	0.60	F(1,42)=3.6	F(5,183)=2.0	F(5,183)=0.5
	1 month	12.3(1.6)	15.2(1.4)	0.19	P = 0.07	P = NS	P = NS
	3 months	11.9(1.7)	13.4(1.5)	0.44
	6 months	11.2(1.8)	13.7(1.5)	0.26
	9 months	10.6(1.9)	14.5(1.5)	0.07
	12 months	11.3(2.0)	9.6(1.6)**	0.86
QIDS SR	Baseline	10.6(0.9)	10.9(0.8)	0.78	F(1,42)=0.3	F(5,135)=8.5	F(5,135)=0.7
	1 month	9.9(0.9)	9.5(0.8)	0.71	P = NS	P < 0.0001	P = NS
	3 months	7.8(1.1)*	9.4(0.9)	0.27
	6 months	7.9(1.1)*	7.5(1.0)**	0.79
	9 months	7.0(1.2)**	8.9(1.0)†	0.23
	12 months	6.0(1.1)***	5.5(1.0)****	0.76
CGI	Baseline	2.8(0.2)	2.8(0.2)	0.94	F(1,42)=3.1	F(5,152)=0.4	F(5,152)=1.2
	1 month	2.7(0.2)	2.7(0.2)	0.78	P = NS	P = NS	P = NS
	3 months	2.6(0.2)	2.8(0.2)	0.45
	6 months	2.6(0.3)	3.1(0.2)	0.10
	9 months	2.6(0.3)	3.0(0.2)	0.21
	12 months	2.4(0.3)	3.0(0.2)	0.04

All values are LS-mean (SE) unless otherwise specified.

We used a mixed model repeated measures (MMRM) approach with time (baseline, 1-, 3-, 6-, 9-, 12-month visits) as the within-subjects factor and treatment (RLAI+TAU vs. TAU alone) as the between-subjects factor. Analyses were adjusted for baseline dependent measure values. Reported p-values reflect between-group differences at the corresponding time point. Statistically significant within-group changes at each time point (relative to baseline values) are represented with asterisks:

^****p ≤ 0.0001

^***p ≤ 0.001

^**p≤0.01

^*p < 0.05

^†p < 0.08 (trend) for within group comparison for each time point against the baseline values.