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

Primary Purpose

Refractory Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

On-Stimulation

Off-Stimulation

About this trial

This is an interventional treatment trial for Refractory Schizophrenia focused on measuring Treatment-Resistant Schizophrenia, Deep Brain Stimulation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged between 18 and 55 years.
DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit.
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.
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.
Current CGI score 6 or more
Stable antipsychotic treatment for last 2 months.
Women of childbearing age using medically approved contraceptive methods.
Adequate familiar or social support during all study procedures.

Exclusion Criteria:

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

Sites / Locations

FIDMAG Germanes Hospitalàries Research Foundation
Department of Psychiatry. Hospital Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

On-Stimulation

Off-Stimulation

Arm Description

Disease condition is assessed with stimulation turned "on"

Disease condition is assessed with stimulation turned "off"

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

Scale to assess changes in schizophrenia' symptoms

Secondary Outcome Measures

Clinical Global Impression-Schizophrenia (CGI-SCH)

Scale to assess changes in schizophrenia symptoms' severity, global improvement or change.

Global Functioning Scale (GFS)

Scale to assess changes in social, occupational, and psychological functioning

Social Functioning Scale (SFS)

Scale to assess changes in social functioning

Personal and Social Performance (PSP)

Scale to assess changes in functioning

Psychotic Symptom Rating Scales (PSYRATS)

Scale to assess changes in hallucinations

Scale for the Assessment of Negative Symptoms (SANS)

Scale to assess changes in negative symptoms of schizophrenia

Calgary Depression Scale for Schizophrenia (CDSS)

Scale to assess changes in depressive symptoms

Performance-Based Skills Assessment (UPSA)

Scale to assess changes in functional capacity

Neuropsychological Assessment

Battery of neuropsychological tests to assess changes in cognition

Cerebral metabolism (PET scans)

Assessment of changes in brain blow flow using the nuclear medicine procedure, PET

n-Back (fMRI scan)

Task to measure changes in working memory

Adverse events (AEs)

All unexpected medical problem that happens during DBS treatment

Full Information

NCT ID

NCT02377505

First Posted

February 26, 2015

Last Updated

February 17, 2020

Sponsor

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

Collaborators

Fondo de Investigacion Sanitaria

1. Study Identification

Unique Protocol Identification Number

NCT02377505

Brief Title

Deep Brain Stimulation in Treatment Resistant Schizophrenia

Acronym

DBS-SCHIZO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 2013 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Schizophrenia

Keywords

Treatment-Resistant Schizophrenia, Deep Brain Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

On-Stimulation

Arm Type

Active Comparator

Arm Description

Disease condition is assessed with stimulation turned "on"

Arm Title

Off-Stimulation

Arm Type

Placebo Comparator

Arm Description

Disease condition is assessed with stimulation turned "off"

Intervention Type

Device

Intervention Name(s)

On-Stimulation

Intervention Description

The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"

Intervention Type

Device

Intervention Name(s)

Off-Stimulation

Intervention Description

The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"

Primary Outcome Measure Information:

Title

Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

Description

Scale to assess changes in schizophrenia' symptoms

Time Frame

Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

Secondary Outcome Measure Information:

Title

Clinical Global Impression-Schizophrenia (CGI-SCH)

Description

Scale to assess changes in schizophrenia symptoms' severity, global improvement or change.

Time Frame

Changes from baseline score to 1-12 months scores

Title

Global Functioning Scale (GFS)

Description

Scale to assess changes in social, occupational, and psychological functioning

Time Frame

Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

Title

Social Functioning Scale (SFS)

Description

Scale to assess changes in social functioning

Time Frame

Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

Title

Personal and Social Performance (PSP)

Description

Scale to assess changes in functioning

Time Frame

Changes from baseline score to 1-12 months scores

Title

Psychotic Symptom Rating Scales (PSYRATS)

Description

Scale to assess changes in hallucinations

Time Frame

Changes from baseline score to 1-12 months scores

Title

Scale for the Assessment of Negative Symptoms (SANS)

Description

Scale to assess changes in negative symptoms of schizophrenia

Time Frame

Changes from baseline score to 1-12 months scores

Title

Calgary Depression Scale for Schizophrenia (CDSS)

Description

Scale to assess changes in depressive symptoms

Time Frame

Changes from baseline score to 1-12 months scores

Title

Performance-Based Skills Assessment (UPSA)

Description

Scale to assess changes in functional capacity

Time Frame

Changes from baseline score to 12 months score

Title

Neuropsychological Assessment

Description

Battery of neuropsychological tests to assess changes in cognition

Time Frame

Changes from baseline score to 12 months score

Title

Cerebral metabolism (PET scans)

Description

Assessment of changes in brain blow flow using the nuclear medicine procedure, PET

Time Frame

Changes from baseline scan to 6 and 12 months scans

Title

n-Back (fMRI scan)

Description

Task to measure changes in working memory

Time Frame

Changes from baseline scan to 6 and 12 months scans

Title

Adverse events (AEs)

Description

All unexpected medical problem that happens during DBS treatment

Time Frame

Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged between 18 and 55 years. DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit. Determined to be treatment-resistant as demonstrated by: Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects. ECT is contraindicated or have failed to produce a maintained response. 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. Current CGI score 6 or more Stable antipsychotic treatment for last 2 months. Women of childbearing age using medically approved contraceptive methods. Adequate familiar or social support during all study procedures. Exclusion Criteria: MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI History of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed Current suicidal ideation, plan or intent for self-harm during last 2 months. Evidence of global cognitive impairment. Current acute, serious or unstable illnesses. History of substance abuse (other than tobacco or caffeine). Comorbid axis I or II DSM IV-TR disorders. Female patients who are pregnant or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iluminada Corripio, MD, PhD

Organizational Affiliation

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Official's Role

Principal Investigator

Facility Information:

Facility Name

FIDMAG Germanes Hospitalàries Research Foundation

City

Sant Boi de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Department of Psychiatry. Hospital Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27104842

Citation

Salgado-Lopez L, Pomarol-Clotet E, Roldan A, Rodriguez R, Molet J, Sarro S, Alvarez E, Corripio I. Letter to the Editor: Deep brain stimulation for schizophrenia. J Neurosurg. 2016 Jul;125(1):229-30. doi: 10.3171/2015.12.JNS152874. Epub 2016 Apr 22. No abstract available.

Results Reference

result

PubMed Identifier

27113497

Citation

Corripio I, Sarro S, McKenna PJ, Molet J, Alvarez E, Pomarol-Clotet E, Portella MJ. Clinical Improvement in a Treatment-Resistant Patient With Schizophrenia Treated With Deep Brain Stimulation. Biol Psychiatry. 2016 Oct 15;80(8):e69-70. doi: 10.1016/j.biopsych.2016.03.1049. Epub 2016 Mar 10. No abstract available.

Results Reference

result

PubMed Identifier

31927311

Citation

Corripio I, Roldan A, Sarro S, McKenna PJ, Alonso-Solis A, Rabella M, Diaz A, Puigdemont D, Perez-Sola V, Alvarez E, Arevalo A, Padilla PP, Ruiz-Idiago JM, Rodriguez R, Molet J, Pomarol-Clotet E, Portella MJ. Deep brain stimulation in treatment resistant schizophrenia: A pilot randomized cross-over clinical trial. EBioMedicine. 2020 Jan;51:102568. doi: 10.1016/j.ebiom.2019.11.029. Epub 2020 Jan 8.

Results Reference

result

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Deep Brain Stimulation in Treatment Resistant Schizophrenia

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