Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PI12/00042 | Other Identifier | Fundació Institut Recerca-Hospital Santa Creu i Sant Pau |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Stimulation | Active Comparator | Disease condition is assessed with stimulation turned "on" |
|
| Off-Stimulation | Placebo Comparator | Disease condition is assessed with stimulation turned "off" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-Stimulation | Device | The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Schizophrenia (CGI-SCH) | 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) |
Not provided
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 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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iluminada Corripio, MD, PhD | Department of Psychiatry. Hospital Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FIDMAG Germanes Hospitalà ries Research Foundation | Sant Boi de Llobregat | Barcelona | 08035 | Spain | ||
| Department of Psychiatry. Hospital Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27104842 | Result | 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. | |
| 27113497 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000090663 | Schizophrenia, Treatment-Resistant |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Off-Stimulation | Device | The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off" |
|
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) | 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) | Scale to assess changes in functioning | Changes from baseline score to 1-12 months scores |
| Psychotic Symptom Rating Scales (PSYRATS) | Scale to assess changes in hallucinations | 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 | Changes from baseline score to 1-12 months scores |
| Calgary Depression Scale for Schizophrenia (CDSS) | Scale to assess changes in depressive symptoms | Changes from baseline score to 1-12 months scores |
| Performance-Based Skills Assessment (UPSA) | Scale to assess changes in functional capacity | Changes from baseline score to 12 months score |
| Neuropsychological Assessment | Battery of neuropsychological tests to assess changes in cognition | 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 | Changes from baseline scan to 6 and 12 months scans |
| n-Back (fMRI scan) | Task to measure changes in working memory | Changes from baseline scan to 6 and 12 months scans |
| Adverse events (AEs) | 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) |
| Barcelona |
| 08025 |
| Spain |
| 31927311 | Result | 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. |