An open pilot study of zonisamide augmentation in major depressive patients not responding to a low dose trial with duloxetine: preliminary results on tolerability and clinical effects

Table 2 Week 24 comparison of demographic and clinical features of responders vs non-responders

	Responders, N = 14 (58.3%)	Non-responders, N = 10 (41.7%)	t or χ ² (df = 1)	P value
Weight (in kg)	65.5 ± 11.23	65.90 ± 13.12	22	NS
Clinical features (%)
HAM-D total score	1.71 ± 1.32	13.70 ± 5.14	8.405	0.001
HAM-A total score	2.93 ± 2.05	14.80 ± 4.21	9.182	0.001
YMRS total score	3.21 ± 5.76	2.40 ± .843	-0.440	NS
ASEX total score	12.71 ± 1.89	18.58 ± 4.87	5.129	0.001
Side effects profile (%)
Diarrhea	0	0	-	-
Tremors	0	0	-	-
Poor coordination	0	2 (8.3%)	3.055	NS
Dizziness	0	0	-	-
Blurred vision	0	0	-	-
Ringing in ears	0	0	-	-
Difficult urination	0	4 (16.7%)	6.720	0.010
Painful urination	0	0	-	-
Pollachiuria	0	4 (16.7%)	6.720	0.010
Menstrual irregularity	0	0	-	-
Insomnia	2 (8.3%)	4 (16.7%)	2.057	NS
Hypersomnia	0	2 (8.3%)	3.055	NS
Loss of libido	0	8 (33.3%)	16.800	0.001
Anorgasmy	0	6 (25%)	11.200	0.001
Erectile dysfunction	0	0	-	-
Poor concentration	0	10 (41.7%)	24.000	0.001
General malaise	0	6 (25%)	11.200	0.001
Reduced energy	0	10 (41.7%)	24.000	0.001
Hyperphagia	0	0	-	-

'Anorgasmy', 'poor concentration' and 'general malaise' were already significantly improved in those patients responding to a 12 week trial with duloxetine monotherapy and appear to still be associated to response even at week 24 among those patients who continued the study. Also, the difference in the ASEX scores between responders and non-responders at the end of the study is likely due to the fact that the non-responders' scores substantially did not modify within week 12 (before zonisamide augmentation) and week 24, while it reduced in final responders.
ASEX = Arizona Sexual Experience Scale; HAM-A = Hamilton Anxiety Scale; HAM-D = Hamilton Depression Scale; NS = not significant; YMRS = Young Mania Rating Scale.

ISSN: 1744-859X