Transcranial direct current stimulation as early augmentation in adolescent obsessive compulsive disorder: A pilot proof-of-concept randomized control trial

Table 1 Sociodemographic and clinical variables among the groups, mean ± SD, n (%)

	Active tDCS (n = 10)	Sham tDCS (n = 8)	P value
Age, yr	14.4 ± 2.4	14.3 ± 2.5	0.96
Age at onset, yr	12.7 ± 3.6	12.0 ± 1.9	0.69
Duration of symptoms, months	19.8 ± 19.5	28.3 ± 29.2	0.68
Gender, male	5 (50)	6 (75)	0.28
Religion, Hindu	8 (80)	7 (87.5)	0.67
Education
Up to high school	8 (80)	6 (75)	0.8
Up to intermediate	2 (20)	2 (25)
Domicile, urban	6 (60)	4 (50)	0.67
Type of family, nuclear	5 (50)	5 (62.5)	0.59
Number of family members
≤ 5	4 (40)	5 (62.5)	0.34
> 5	6 (60)	3 (37.5)
Family income in Rs/month
≤ 20000	4 (40)	3 (37.5)	0.91
> 20000	6 (60)	5 (62.5)
Developmental delay	2 (20)	-
Past history
Hypothyroidism	1 (10)	-
OCD	2 (20)	-
Depressive episode	-	1 (12.5)
Family history of psychiatric illness, present	2 (20)	-
Co-morbidities
Excoriation	1 (10)	-
Subnormal intelligence	1 (10)	-
Major depressive disorder	-	1 (12.5)
Hospitalization	2 (20)	-

tDCS: Transcranial direct current stimulation; OCD: Obsessive compulsive disorder.

Table 2 Repeated measures ANOVA test for within group and between groups in both intention to treat and per protocol analysis, mean ± SD

Clinical variables	Active tDCS group	Sham tDCS group	Time group interaction (F; P value)
CY-BOCS obsession score (0-20)
Baseline
ITT	13.60 (3.06)	11.38 (3.20)
PP	15.16 (2.92)	11.67 (3.51)
2 wk
ITT	7.40 (3.20)	9.0 (3.21)
PP	6.17 (3.54)	9.00 (3.60)
6 wk
ITT	7.60 (2.84)	6.50 (2.39)
PP	6.33 (2.73)	7.67 (2.08)
12 wk
ITT	6.20 (3.29)	5.75 (2.19)
PP	4.00 (1.67)	5.67 (2.08)
Within the group (F; P value)
ITT	13.42; < 0.0011	39.34; < 0.001	2.20; 0.1291
PP	29.52; 0.0011	9.12; 0.091	3.77; 0.0511
CY-BOCS compulsion score (0-20)
Baseline
ITT	11.50 (2.99)	9.0 (3.82)
PP	11.67 (3.93)	11.0 (1.00)
2 wk
ITT	5.90 (4.09)	6.12 (3.00)
PP	4.0 (4.19)	7.0 (2.64)
6 wk
ITT	5.90 (3.63)	4.50 (2.92)
PP	3.83 (2.71)	6.67 (2.51)
12 wk
ITT	5.10 (4.07)	3.38 (2.06)
PP	2.50 (2.42)	3.67 (1.52)
Within the group (F; P value)
ITT	17.10; < 0.0011	17.83; < 0.001	1.44; 0.2471
PP	34.58; < 0.001	16.05; 0.0151	2.22; 0.115
CY-BOCS total score (0-40)
Baseline
ITT	25.10 (5.06)	20.38 (4.21)
PP	26.83 (6.01)	22.67 (4.51)
2 wk
ITT	13.30 (6.92)	15.12 (4.39)
PP	10.17 (7.19)	16.00 (6.00)
6 wk
ITT	13.50 (5.87)	11.0 (4.57)
PP	10.17 (4.26)	14.33 (4.16)
12 wk
ITT	11.30 (7.18)	9.12 (3.44)
PP	6.50 (3.62)	9.33 (3.51)
Within the group (F; P value)
ITT	16.55; < 0.0011	40.91; < 0.001	2.13; 0.1371
PP	43.76; < 0.001	14.82; 0.0511	3.91; 0.061

¹Greenhouse-Geisser correction. CY-BOCS: Children’s Yale-Brown obsessive-compulsive scale; ITT: Intention to treat; PP: Per protocol.

Table 3 Comparison of mean reduction in Children’s Yale-Brown obsessive-compulsive scale total score between 2 groups across different follow-up periods, mean ± SD

Change in C-YBOCS scores	Active tDCS (n = 10)	Sham tDCS (n = 8)	U value	P value
Baseline vs 2 wk
Obsessions	6.2 ± 4.26	2.37 ± 0.99	18	0.056
Compulsions	5.6 ± 3.75	2.87 ± 1.76	22	0.121
Total	11.8 ± 7.77	5.25 ± 2.22	18	0.056
Baseline vs 6 wk
Obsessions	7.0 ± 3.90	4.87 ± 1.53	22.5	0.131
Compulsions	6.5 ± 3.75	4.5 ± 2.64	25	0.312
Total	11.6 ± 6.93	9.37 ± 2.87	28	0.307
Baseline vs 12 wk
Obsessions	11.2 ± 1.66	9.0 ± 4.0	27.5	0.285
Compulsions	10.0 ± 2.0	7.5 ± 3.2	19	0.069
Total	13.8 ± 8.68	11.25 ± 3.34	29.5	0.373

tDCS: Transcranial direct current stimulation; CY-BOCS: Children’s Yale-Brown obsessive-compulsive scale.