Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

NCT05337904 | Active Not Recruiting DMC

• 1 other identifier: IIBSP-ECP-2019-98
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).

Conditions

Treatment-resistant Schizophrenia; Deep Brain Stimulation

Keywords

Recovery; Deep brain stimulation; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Questionnaire about the Process of Recovery (QPR)

  Changes from baseline total score to 1-12 months total scores

• Rosenberg Self-Esteem Scale (RSES)

  Changes from baseline total score to 12 months total scores

• Herth Hope Index (HHI)

  Changes from baseline total score to 12 months total scores

• Internalized stigma of mental illness scale (ISMI)

  Changes from baseline total score to 12 months total scores

• Beck Cognitive Insight Scale (BCIS)

  Changes from baseline total score to 12 months total scores

Study Arms (2)

On-Stimulation

ACTIVE COMPARATOR

Disease condition is assessed with stimulation turned "on"

Device: On-Stimulation

Off-Stimulation

PLACEBO COMPARATOR

Disease condition is assessed with stimulation turned "off"

Device: Off-Stimulation

Interventions

On-Stimulation DEVICE

The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".

On-Stimulation

Off-Stimulation DEVICE

The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".

Off-Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 18-50 years
• Meet DSM-5 criteria for schizophrenia, with a duration of illness \< than 15 years.
• Meet updated TRS criteria.
• Non-sustained response to electroconvulsive therapy.

You may not qualify if:

• Contraindications to neurosurgery or DBS
• Epilepsy or seizures clozapine-induced
• Suicidal or self-harming behaviour in the last 6 months
• Other psychiatric disorders (including personality disorders)
• Significant cognitive impairment (Vocabulary test WAIS IV-TR, IQ \<70, and SCIP\<55)
• Severe medical non-controlled diseases
• Pregnancy or breastfeeding
• Substance use disorders (except nicotine)

Sponsors & Collaborators

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

Study Sites (1)

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Iluminada Corripio, PhD

  Department of Psychiatry. Hospital Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 20, 2022
• Study Start: September 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)