Table 2.

The Results of Meta-Analysis of Randomized, Placebo-Controlled Trials

Efficacy
Outcome	Number of Studies	Number of Patients	I2	Effect Size	95% Confidence Interval	P
Study-defined relapse rate of depressive symptoms	2	537	0%	Risk ratio = 1.21	0.81 to 1.81	.35
Young Mania Rating Scale total scores	2	532	0%	Weighted mean differences = -5.80	-7.57 to -4.04	<.00001
Montgomery-Asberg Depression Scale total scores	2	532	0%	Weighted mean differences = -1.76	-3.23 to -0.28	.02
Clinical Global Impressions- Severity scores	2	532	0%	Weighted mean differences = -0.76	-1.03 to -0.50	<.00001
Safety
Discontinuation due to all-cause*	2	570	66%	Risk ratio = 0.75	0.61 to 0.92	.007
Discontinuation due to adverse events	2	570	0%	Risk ratio = 1.99	0.49 to 8.07	.33
Discontinuation due to death	2	570	No deaths were reported.
Discontinuation due to withdrawal consent	2	570	0%	Risk ratio = 1.07	0.65 to 1.76	.80
At least one adverse event	2	570	21%	Risk ratio = 1.10	0.94 to 1.28	.23
Potential prolactin-related adverse events**, a	2	570	0%	Risk ratio = 4.82	1.88 to 12.40	.001
Somnolence	2	570	0%	Risk ratio = 1.82	0.62 to 5.38	.28
Insomnia	2	570	0%	Risk ratio = 1.03	0.66 to 1.60	.91
Mania***	2	570	0%	Risk ratio = 0.31	0.16 to 0.63	.001
Depression	2	570	39%	Risk ratio = 1.57	0.57 to 4.31	.38
Use of benzodiazepines****	2	570	0%	Risk ratio = 0.54	0.32 to 0.91	.02
Anxiety	2	570	0%	Risk ratio = 0.85	0.39 to 1.87	.69
Headache	2	570	73%	Risk ratio = 0.53	0.10 to 2.67	.44
Diabetes mellitus	2	570	0%	Risk ratio = 3.91	0.43 to 35.18	.22
Weight gain (≥7% increased) *****	2	570	0%	Risk ratio = 3.80	2.00 to 7.21	<.0001

^a Adverse events considered to be potentially prolactin-related (such as galactorrhea or libido decreased), as reported by the investigator.

*Number need to harm = −5, P = .006.

**Number need to harm = not significant.

***Number need to harm = −14, P = .03.

****Number need to harm = −17, P = .02.

*****Number need to harm = 10, P < .00001.