A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lamotrigine in the maintenance treatment of Chinese adult patients with bipolar I disorder

Zhang, Ling; Zhang, Honggeng; Lv, Lu-xian; Tan, Qingrong; Xu, Xiufeng; Hu, Jian; Zi, Lu; Cooper, James; Phansalkar, Abhay; Wang, Gang

doi:10.1186/s40345-022-00266-4

International Journal of Bipolar Disorders

Table 2 Change from baseline in secondary efficacy and quality of life parameters

From: A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lamotrigine in the maintenance treatment of Chinese adult patients with bipolar I disorder

Parameter	Treatment	N	Change from baseline, LS mean (SE)	Treatment difference (95% CI)	p value
Secondary efficacy parameters
CGI-S	Lamotrigine	130	0.5 (0.15)	− 0.2 (− 0.5, 0.1)	0.245
CGI-S	Placebo	133	0.7 (0.15)	− 0.2 (− 0.5, 0.1)	0.245
CGI-I	Lamotrigine	130	2.7 (0.21)	0.0 (− 0.4, 0.5)	0.833
CGI-I	Placebo	133	2.6 (0.20)	0.0 (− 0.4, 0.5)	0.833
HAMD	Lamotrigine	130	1.8 (0.84)	− 1.2 (− 3.0, 0.5)	0.155
HAMD	Placebo	133	3.0 (0.83)	− 1.2 (− 3.0, 0.5)	0.155
YMRS	Lamotrigine	130	2.8 (0.88)	0.4 (− 1.4, 2.2)	0.661
YMRS	Placebo	133	2.4 (0.87)	0.4 (− 1.4, 2.2)	0.661
GAS	Lamotrigine	130	− 4.9 (1.77)	− 0.1 (− 3.7, 3.5)	0.945
GAS	Placebo	133	− 4.7 (1.75)	− 0.1 (− 3.7, 3.5)	0.945
Body weight	Lamotrigine	128	− 1.56 (0.407)	− 0.84 (− 1.66, − 0.01)	0.047
Body weight	Placebo	130	− 0.72 (0.399)	− 0.84 (− 1.66, − 0.01)	0.047
Quality of life parameters
Physical functioning	Lamotrigine	127	− 0.0 (0.09)	0.0 (− 0.2, 0.2)	0.868
Physical functioning	Placebo	125	− 0.1 (0.09)	0.0 (− 0.2, 0.2)	0.868
Physical role functioning	Lamotrigine	127	− 0.2 (0.12)	0.1 (− 0.2, 0.3)	0.566
Physical role functioning	Placebo	125	− 0.3 (0.12)	0.1 (− 0.2, 0.3)	0.566
Emotional role functioning	Lamotrigine	127	− 0.2 (0.15)	0.3 (0.0, 0.6)	0.042
Emotional role functioning	Placebo	125	− 0.5 (0.15)	0.3 (0.0, 0.6)	0.042
Social functioning	Lamotrigine	127	− 0.1 (0.13)	0.2 (− 0.1, 0.5)	0.180
Social functioning	Placebo	125	− 0.3 (0.13)	0.2 (− 0.1, 0.5)	0.180
Bodily pain	Lamotrigine	127	− 0.2 (0.12)	0.1 (− 0.2, 0.3)	0.585
Bodily pain	Placebo	125	− 0.3 (0.12)	0.1 (− 0.2, 0.3)	0.585
Mental health	Lamotrigine	127	− 0.3 (0.15)	0.2 (− 0.1, 0.5)	0.164
Mental health	Placebo	125	− 0.5 (0.15)	0.2 (− 0.1, 0.5)	0.164
Vitality	Lamotrigine	127	− 0.1 (0.13)	0.2 (− 0.1, 0.5)	0.139
Vitality	Placebo	125	− 0.3 (0.13)	0.2 (− 0.1, 0.5)	0.139
General health perception	Lamotrigine	127	0.0 (0.11)	0.1 (− 0.1, 0.3)	0.355
General health perception	Placebo	125	− 0.1 (0.12)	0.1 (− 0.1, 0.3)	0.355

Statistical analysis performed using ANCOVA with covariates of site, CGI-S baseline score and treatment
ANCOVA Analysis of covariance; CI confidence interval; CGI-I Clinical Global Impressions of Improvement; CGI-S Clinical Global Impressions of Severity; GAS Global Assessment Scale; HAMD Hamilton Depression Rating Scale; SE standard error; YMRS Young Mania Rating Scale
Analysis population: RD full analysis population

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