Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia
NCT ID: NCT05337904
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
6 participants
INTERVENTIONAL
2023-09-01
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Brain Stimulation in Treatment Resistant Schizophrenia
NCT02377505
Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)
NCT06542900
DBS in Treatment Resistant Major Depression
NCT01268137
Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
NCT05167942
DBS for Treatment Resistant Depression
NCT01983904
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Moreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are:
i) to optimizethe efficacy and tolerability of DBS in TRS;
ii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
On-Stimulation
Disease condition is assessed with stimulation turned "on"
On-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
Off-Stimulation
Disease condition is assessed with stimulation turned "off"
Off-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
On-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
Off-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meet DSM-5 criteria for schizophrenia, with a duration of illness \< than 15 years.
* Meet updated TRS criteria.
* Non-sustained response to electroconvulsive therapy.
Exclusion Criteria
* 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)
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iluminada Corripio, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIBSP-ECP-2019-98
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.