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Deep Brain Stimulation in Treatment Resistant Schizophrenia (DBS-SCHIZO)

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ClinicalTrials.gov Identifier: NCT02377505
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.

Condition or disease Intervention/treatment Phase
Refractory Schizophrenia Device: On-Stimulation Device: Off-Stimulation Not Applicable

Detailed Description:

The first phase of the study will consist of implanting electrodes. Recruited patients will be random to 2 targets: (1) medial prefrontal cortex (mPFC); (2) nucleus accumbens (NAcc). Continuous stimulation will be applied until the patients stabilise clinically. This period is anticipated between 6 and 9 months.

After this stage, the next phase will consist of the crossover study. Those patients who respond to DBS will be randomly distributed in two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.

Weekly visits during first month after, and fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance.

Patients who complete the study and respond to treatment with DBS will be provided continuing with treatment, and keeping control visits to assess the long-term effectiveness.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation in Treatment Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
Study Start Date : January 2013
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: On-Stimulation
Disease condition is assessed with stimulation turned "on"
Device: On-Stimulation
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"

Placebo Comparator: Off-Stimulation
Disease condition is assessed with stimulation turned "off"
Device: Off-Stimulation
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"




Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months) ]

Secondary Outcome Measures :
  1. Clinical Global Impression-Schizophrenia (CGI-SCH) [ Time Frame: Changes from baseline score to 1-12 months scores ]
  2. Global Functioning Scale (GFS) [ Time Frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores ]
  3. Social Functioning Scale (SFS) [ Time Frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores ]
  4. Personal and Social Performance (PSP) [ Time Frame: Changes from baseline score to 1-12 months scores ]
  5. Psychotic Symptom Rating Scales (PSYRATS) [ Time Frame: Changes from baseline score to 1-12 months scores ]
  6. Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Changes from baseline score to 1-12 months scores ]
  7. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Changes from baseline score to 1-12 months scores ]
  8. Performance-Based Skills Assessment (UPSA) [ Time Frame: Changes from baseline score to 12 months score ]
  9. Neuropsychological Assessment [ Time Frame: Changes from baseline score to 12 months score ]
  10. Cerebral metabolism (PET scans) [ Time Frame: Changes from baseline scan to 6 and 12 months scans ]
  11. n-Back (fMRI scan) [ Time Frame: Changes from baseline scan to 6 and 12 months scans ]
  12. Adverse events (AEs) [ Time Frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged between 18 and 55 years.
  2. DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit.
  3. Determined to be treatment-resistant as demonstrated by:

    1. Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
    2. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
    3. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
    4. ECT is contraindicated or have failed to produce a maintained response.
  4. Persistence of positive symptoms defined as i) requiring a score of 4 (mild) or more on at least 2 of the next PANSS items: delusions, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
  5. Current CGI score 6 or more
  6. Stable antipsychotic treatment for last 2 months.
  7. Women of childbearing age using medically approved contraceptive methods.
  8. Adequate familiar or social support during all study procedures.

Exclusion Criteria:

  1. MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
  2. History of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed
  3. Current suicidal ideation, plan or intent for self-harm during last 2 months.
  4. Evidence of global cognitive impairment.
  5. Current acute, serious or unstable illnesses.
  6. History of substance abuse (other than tobacco or caffeine).
  7. Comorbid axis I or II DSM IV-TR disorders.
  8. Female patients who are pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377505


Contacts
Contact: Mireia Rabella, BSc +34 93 553 78 40 mrabella@santpau.cat
Contact: Eva M Grasa, BSc +34 93 553 78 40 egrasa@santpau.cat

Locations
Spain
FIDMAG Germanes Hospitalàries Research Foundation Recruiting
Sant Boi de Llobregat, Barcelona, Spain, 08035
Contact: Salvador MD Sarró, PhD    93 652 99 99 ext 1486    ssarro@fidmag.com   
Department of Psychiatry. Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Iluminada MD Corripio, PhD    +34 93 553 78 40    icorripio@santpau.cat   
Contact: Eva Grasa, BSc    +34 93 553 78 40    egrasa@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Iluminada Corripio, MD, PhD Department of Psychiatry. Hospital Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02377505     History of Changes
Other Study ID Numbers: IIBSP-ECP-2013-20
PI12/00042 ( Other Identifier: Fundació Institut Recerca-Hospital Santa Creu i Sant Pau )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Treatment-Resistant Schizophrenia
Deep Brain Stimulation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders