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Research Paper

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

Dolors Puigdemont, Maria J. Portella, Rosario Pérez-Egea, Joan Molet, Alexandre Gironell, Javier de Diego-Adeliño, Anna Martín, Rodrigo Rodríguez, Enric Àlvarez, Francesc Artigas and Víctor Pérez
J Psychiatry Neurosci July 01, 2015 40 (4) 224-231; DOI: https://doi.org/10.1503/jpn.130295
Dolors Puigdemont
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Maria J. Portella
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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  • For correspondence: [email protected]
Rosario Pérez-Egea
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Joan Molet
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Alexandre Gironell
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Javier de Diego-Adeliño
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Anna Martín
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Rodrigo Rodríguez
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Enric Àlvarez
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Francesc Artigas
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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Víctor Pérez
From the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental, Institut d’Investigació Biomèdica Sant Pau (Puigdemont, Portella, Pérez-Egea, de Diego-Adeliño, Martín, Àlvarez, Pérez); the Department of Neurosurgery, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Institut d’Investigació Biomèdica Sant Pau (Molet, Rodríguez); the Department of Neurology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB). Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas, Institut d’Investigació Biomèdica Sant Pau (Gironell); and the Department of Neurochemistry and Neuropharmacology, Institut d’Investigacions Biomèdiques de Barcelona, IDIBAPS, Consejo Superior de Investigaciones Cientificas, IDIBAPS, Centro de Investigación Biomédica en Red de Salud Mental (Artigas).
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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.

Tables

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    Table 1

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

    Group, mean ± SD
    CharacteristicOFF–ON, n = 2ON–OFF, n = 3
    Age at surgery, yr42.0 ± 9.950.7 ± 14.3
    Age at MDD onset, yr27.5 ± 0.720.3 ± 2.5
    No. of previous episodes3.5 ± 0.77.3 ± 6.1
    No. of previous hospitalizations6.5 ± 7.78.7 ± 8.1
    MADRS
     Prerandomization2.0 ± 2.83.4 ± 2.5
     First month2.0 ± 1.49.4 ± 10.7
     Second month11.5 ± 2.18.4 ± 2.8
     Third month8.5 ± 12.07.7 ± 4.5
     Fourth month2.0 ± 2.89.7 ± 10.7
     Fifth month2.0 ± 2.815.4 ± 6.5
     Sixth month2.0 ± 2.814.0 ± 8.5
     End point4.0 ± 0.75.7 ± 2.1
    HAMD-17
     Prerandomization3.5 ± 2.13.7 ± 2.3
     First month6.0 ± 8.58.7 ± 1.2
     Second month9.0 ± 4.26.0 ± 2.0
     Third month8.5 ± 12.07.0 ± 5.6
     Fourth month3.0 ± 1.47.7 ± 7.4
     Fifth month2.5 ± 2.111.3 ± 5.0
     Sixth month2.0 ± 2.811.3 ± 5.0
     End point3.5 ± 0.75.3 ± 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.

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    Table 2

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

    PatientTrial armActive electrodesStimulation parametersPharmacological treatment
    Patient 1OFF-ONL 0(−) 2(+)A = 4.5 VDuloxetine (120 mg/d)
    R 4(−) 6(+)D = 210 μsQuetiapine (1000 mg/d)
    F = 135 HzLorazepam (2 mg/d)
    Patient 2ON-OFFL 0(−) 3(+)A = 5 VVenlafaxine (300 mg/d)
    R 4(−) 7(+)D = 180 μsMirtazapine (60 mg/d)
    F = 135 HzLithium (400 mg/d)
    Diazepam (30 mg/d)
    Quetiapine (200 mg/d)
    Patient 3ON-OFFL 0(−) 1(+)A = 5 VDuloxetine (90mg/d)
    R 5(−) 6(+)D = 180 μsMirtazapine (30mg/d)
    F = 135 HzOlanzapine (5mg/d)
    Diazepam (50mg/d)
    Alprazolam (6mg/d)
    Zolpidem (10mg/d)
    Levomepromazine (50 mg/d)
    Pregabaline (300mg/d)
    Patient 4ON-OFFL 0(−) 1(+)A = 4 VDuloxetine (120 mg/d)
    R 4(−) 5(+)D = 180 μsMirtazapine (60 mg/d)
    F = 135 HzValproate (1500 mg/d)
    Trazodone (200 mg/d)
    Lorazepam (5mg/d)
    Midazolam (7.5 mg/d)
    Patient 5OFF-ONL 0(−) 2(+)A = 3.5 VImipramine (100 mg/d)
    R 4(−) 6(+)D = 120 μsMedazepam (10 mg/d)
    F = 135 Hz
    • 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.

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Journal of Psychiatry and Neuroscience: 40 (4)
J Psychiatry Neurosci
Vol. 40, Issue 4
1 Jul 2015
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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
Dolors Puigdemont, Maria J. Portella, Rosario Pérez-Egea, Joan Molet, Alexandre Gironell, Javier de Diego-Adeliño, Anna Martín, Rodrigo Rodríguez, Enric Àlvarez, Francesc Artigas, Víctor Pérez
J Psychiatry Neurosci Jul 2015, 40 (4) 224-231; DOI: 10.1503/jpn.130295

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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
Dolors Puigdemont, Maria J. Portella, Rosario Pérez-Egea, Joan Molet, Alexandre Gironell, Javier de Diego-Adeliño, Anna Martín, Rodrigo Rodríguez, Enric Àlvarez, Francesc Artigas, Víctor Pérez
J Psychiatry Neurosci Jul 2015, 40 (4) 224-231; DOI: 10.1503/jpn.130295
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