Deep Brain Stimulation in Treatment Resistant Schizophrenia

Refractory Schizophrenia Clinical Trial

— DBS-SCHIZO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377505
• Other study ID #: IIBSP-ECP-2013-20
• Secondary ID: PI12/00042
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 23, 2019

Study information

• Verified date: February 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 23, 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractory Schizophrenia
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Spain	Department of Psychiatry. Hospital Santa Creu i Sant Pau	Barcelona
Spain	FIDMAG Germanes Hospitalàries Research Foundation	Sant Boi de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Corripio I, Roldán A, Sarró S, McKenna PJ, Alonso-Solís A, Rabella M, Díaz A, Puigdemont D, Pérez-Solà V, Álvarez E, Arévalo A, Padilla PP, Ruiz-Idiago JM, Rodríguez R, Molet J, Pomarol-Clotet E, Portella MJ. Deep brain stimulation in treatment resistant — View Citation

Corripio I, Sarró S, McKenna PJ, Molet J, Álvarez 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.bio — View Citation

Salgado-López L, Pomarol-Clotet E, Roldán A, Rodríguez R, Molet J, Sarró S, Álvarez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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
Secondary	Global Functioning Scale (GFS)	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
Secondary	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
Secondary	Personal and Social Performance (PSP)	Scale to assess changes in functioning	Changes from baseline score to 1-12 months scores
Secondary	Psychotic Symptom Rating Scales (PSYRATS)	Scale to assess changes in hallucinations	Changes from baseline score to 1-12 months scores
Secondary	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
Secondary	Calgary Depression Scale for Schizophrenia (CDSS)	Scale to assess changes in depressive symptoms	Changes from baseline score to 1-12 months scores
Secondary	Performance-Based Skills Assessment (UPSA)	Scale to assess changes in functional capacity	Changes from baseline score to 12 months score
Secondary	Neuropsychological Assessment	Battery of neuropsychological tests to assess changes in cognition	Changes from baseline score to 12 months score
Secondary	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
Secondary	n-Back (fMRI scan)	Task to measure changes in working memory	Changes from baseline scan to 6 and 12 months scans
Secondary	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)