Refractory SchizophreniaDBS-SCHIZONCT02377505
Deep Brain Stimulation in Treatment Resistant Schizophrenia
A study testing On-Stimulation and Off-Stimulation in people with Refractory Schizophrenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- On-Stimulation and Off-Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2013to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, 08025
FIDMAG Germanes Hospitalàries Research Foundation
Sant Boi de Llobregat, Barcelona, 08035
About this study
Official title: 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.
Read the 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.
- Conditions
- Refractory Schizophrenia
- Being tested
- On-Stimulation, Off-Stimulation
- Keywords
- Treatment-Resistant Schizophrenia, Deep Brain Stimulation
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-StimulationDevice
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"
Off-StimulationDevice
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"
| Study group | Role | What they receive |
|---|---|---|
| On-Stimulation | Active comparator | Disease condition is assessed with stimulation turned "on" Receives: Device: On-Stimulation |
| Off-Stimulation | Placebo comparator | Disease condition is assessed with stimulation turned "off" Receives: Device: Off-Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Scale to assess changes in schizophrenia' symptoms
Measured: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Secondary outcomes (12)
Clinical Global Impression-Schizophrenia (CGI-SCH)
Scale to assess changes in schizophrenia symptoms' severity, global improvement or change.
Measured: Changes from baseline score to 1-12 months scores
Global Functioning Scale (GFS)
Scale to assess changes in social, occupational, and psychological functioning
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Social Functioning Scale (SFS)
Scale to assess changes in social functioning
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Personal and Social Performance (PSP)
Scale to assess changes in functioning
Measured: Changes from baseline score to 1-12 months scores
Psychotic Symptom Rating Scales (PSYRATS)
Scale to assess changes in hallucinations
Measured: Changes from baseline score to 1-12 months scores
Scale for the Assessment of Negative Symptoms (SANS)
Scale to assess changes in negative symptoms of schizophrenia
Measured: Changes from baseline score to 1-12 months scores
Calgary Depression Scale for Schizophrenia (CDSS)
Scale to assess changes in depressive symptoms
Measured: Changes from baseline score to 1-12 months scores
Performance-Based Skills Assessment (UPSA)
Scale to assess changes in functional capacity
Measured: Changes from baseline score to 12 months score
Neuropsychological Assessment
Battery of neuropsychological tests to assess changes in cognition
Measured: Changes from baseline score to 12 months score
Cerebral metabolism (PET scans)
Assessment of changes in brain blow flow using the nuclear medicine procedure, PET
Measured: Changes from baseline scan to 6 and 12 months scans
n-Back (fMRI scan)
Task to measure changes in working memory
Measured: Changes from baseline scan to 6 and 12 months scans
Adverse events (AEs)
All unexpected medical problem that happens during DBS treatment
Measured: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionFeb 2017
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractory SchizophreniaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
- Investigators
- Iluminada Corripio, MD, PhD, Principal investigator, Department of Psychiatry. Hospital Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377505
- Sponsor's protocol ID
- IIBSP-ECP-2013-20
- Other IDs
- PI12/00042
- Acronym
- DBS-SCHIZO
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2015
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27104842Corripio 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.
PubMed 27113497Corripio 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.
PubMed 31927311
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation in Treatment Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT02377505
- Acronym / sponsor ID
- DBS-SCHIZO / IIBSP-ECP-2013-20
- Conditions
- Refractory Schizophrenia
- Keywords
- Treatment-Resistant Schizophrenia, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-Stimulation | Active comparator | Device: On-StimulationDisease condition is assessed with stimulation turned "on" |
| Off-Stimulation | Placebo comparator | Device: Off-StimulationDisease condition is assessed with stimulation turned "off" |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-StimulationThe surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on" | Device | On-Stimulation |
| Off-StimulationThe surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off" | Device | Off-Stimulation |
Primary outcome
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
12 secondary outcomes
Clinical Global Impression-Schizophrenia (CGI-SCH)
Time frame: 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
Social Functioning Scale (SFS)
Time frame: 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
Psychotic Symptom Rating Scales (PSYRATS)
Time frame: 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
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Changes from baseline score to 1-12 months scores
Performance-Based Skills Assessment (UPSA)
Time frame: Changes from baseline score to 12 months score
Neuropsychological Assessment
Time frame: Changes from baseline score to 12 months score
Cerebral metabolism (PET scans)
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Results publication: PubMed 27104842Salgado-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 publication: PubMed 27113497Corripio 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 publication: PubMed 31927311Corripio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iluminada Corripio, MD, PhD principal investigator
Department of Psychiatry. Hospital Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Stimulation and Off-Stimulation in people with Refractory Schizophrenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377505, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.