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

February 17, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Deep Brain Stimulation in Treatment Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Department of Psychiatry. Hospital Santa Creu i Sant Pau
    • Barcelona
      • Sant Boi de Llobregat, Barcelona, Spain, 08035
        • FIDMAG Germanes Hospitalàries Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Scale to assess changes in schizophrenia' symptoms
Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Schizophrenia (CGI-SCH)
Time Frame: Changes from baseline score to 1-12 months scores
Scale to assess changes in schizophrenia symptoms' severity, global improvement or change.
Changes from baseline score to 1-12 months scores
Global Functioning Scale (GFS)
Time Frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Scale to assess changes in social, occupational, and psychological functioning
Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Social Functioning Scale (SFS)
Time Frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Scale to assess changes in social functioning
Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Personal and Social Performance (PSP)
Time Frame: Changes from baseline score to 1-12 months scores
Scale to assess changes in functioning
Changes from baseline score to 1-12 months scores
Psychotic Symptom Rating Scales (PSYRATS)
Time Frame: Changes from baseline score to 1-12 months scores
Scale to assess changes in hallucinations
Changes from baseline score to 1-12 months scores
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame: Changes from baseline score to 1-12 months scores
Scale to assess changes in negative symptoms of schizophrenia
Changes from baseline score to 1-12 months scores
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Changes from baseline score to 1-12 months scores
Scale to assess changes in depressive symptoms
Changes from baseline score to 1-12 months scores
Performance-Based Skills Assessment (UPSA)
Time Frame: Changes from baseline score to 12 months score
Scale to assess changes in functional capacity
Changes from baseline score to 12 months score
Neuropsychological Assessment
Time Frame: Changes from baseline score to 12 months score
Battery of neuropsychological tests to assess changes in cognition
Changes from baseline score to 12 months score
Cerebral metabolism (PET scans)
Time Frame: Changes from baseline scan to 6 and 12 months scans
Assessment of changes in brain blow flow using the nuclear medicine procedure, PET
Changes from baseline scan to 6 and 12 months scans
n-Back (fMRI scan)
Time Frame: Changes from baseline scan to 6 and 12 months scans
Task to measure changes in working memory
Changes from baseline scan to 6 and 12 months scans
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)
All unexpected medical problem that happens during DBS treatment
Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Fondo de Investigacion Sanitaria

Investigators

  • Principal Investigator: Iluminada Corripio, MD, PhD, Department of Psychiatry. Hospital Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 23, 2019

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ECP-2013-20
  • PI12/00042 (Other Identifier: Fundació Institut Recerca-Hospital Santa Creu i Sant Pau)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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