Status:
ACTIVE_NOT_RECRUITING
Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Treatment-resistant Schizophrenia
Deep Brain Stimulation
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).
Detailed Description
The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05337904
Start Date
September 1 2023
End Date
July 31 2026
Last Update
July 29 2025
Active Locations (1)
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1
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain