A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention

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Fig. 1
Study selection for the randomized controlled clinical trial. LOCF = last observation carried forward; OFF–ON = 3 mo of sham stimulation followed by 3 mo of active stimulation; ON–OFF = 3 mo of active stimulations followed by 3 mo of sham stimulation.
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Fig. 2
Location of electrode contacts on a sagittal view of the cingulate gyrus. Circles are schematic representations of electrode contacts (“+” indicates positive contacts and “−” indicates negative contacts). Numbers within circles correspond to each patient. Details of stimulating parameters are given in Table 2.
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Fig. 3
Mean change in depression scores based on the 17-item Hamilton Rating Scale for Depression (HAMD-17) for the ON–OFF (3 mo active followed by 3 mo sham) group and the OFF–ON (3 mo sham followed by 3 mo active) group.
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Fig. 4
Individual changes on th 17-item Hamilton Rating Scale for Depression (HAMD-17) scores during active stimulation (ON) and sham stimulation (OFF) periods. Scores on the dark grey background represent relapses; scores on the white background correspond to remissions.

Table 1

Clinical and demographic characteristics of the study sample (n = 5)

	Group, mean ± SD

Characteristic	OFF–ON, n = 2	ON–OFF, n = 3
Age at surgery, yr	42.0 ± 9.9	50.7 ± 14.3
Age at MDD onset, yr	27.5 ± 0.7	20.3 ± 2.5
No. of previous episodes	3.5 ± 0.7	7.3 ± 6.1
No. of previous hospitalizations	6.5 ± 7.7	8.7 ± 8.1
MADRS
Prerandomization	2.0 ± 2.8	3.4 ± 2.5
First month	2.0 ± 1.4	9.4 ± 10.7
Second month	11.5 ± 2.1	8.4 ± 2.8
Third month	8.5 ± 12.0	7.7 ± 4.5
Fourth month	2.0 ± 2.8	9.7 ± 10.7
Fifth month	2.0 ± 2.8	15.4 ± 6.5
Sixth month	2.0 ± 2.8	14.0 ± 8.5
End point	4.0 ± 0.7	5.7 ± 2.1
HAMD-17
Prerandomization	3.5 ± 2.1	3.7 ± 2.3
First month	6.0 ± 8.5	8.7 ± 1.2
Second month	9.0 ± 4.2	6.0 ± 2.0
Third month	8.5 ± 12.0	7.0 ± 5.6
Fourth month	3.0 ± 1.4	7.7 ± 7.4
Fifth month	2.5 ± 2.1	11.3 ± 5.0
Sixth month	2.0 ± 2.8	11.3 ± 5.0
End point	3.5 ± 0.7	5.3 ± 1.2

HAMD-17 = 17-item Hamilton Rating Scale for Depression; MADRS = Montogomery-Åsberg Depression Rating Scale; MDD = major depressive disorder; OFF–ON = 3 mo of sham stimulation followed by 3 mo of active stimulation; ON–OFF = 3 mo of active stimulations followed by 3 mo of sham stimulation; SD = standard deviation.

Table 2

Patient data on randomization, active contacts and stimulating parameters at the beginning of the trial and the medications prescribed at trial entry

A = amplitude; D = pulse width; F = frequency; L = left electrode; OFF–ON = 3 mo of sham stimulation followed by 3 mo of active stimulation; ON–OFF = 3 mo of active stimulations followed by 3 mo of sham stimulation; R = right electrode.