Clinical trial NCT05337904: Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia
Official title: Deep Brain Stimulation: Towards a Novel Intervention Focused on the Recovery of Patients With Treatment-Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment-resistant Schizophrenia
Deep Brain Stimulation
Keywords: Recovery
Deep brain stimulation
Schizophrenia
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.
Primary purpose: TREATMENT

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 schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies .

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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
timeFrame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Secondary outcomes:
measure: Clinical Recovery Outcomes
timeFrame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
measure: Personal Recovery Outcomes
timeFrame: Changes from baseline score to 1-12 months scores
measure: Cognitive Outcomes
timeFrame: Changes from baseline score to 12 months score.
measure: Functioning Outcomes
timeFrame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
measure: Well-being Outcomes
timeFrame: Changes from baseline score to 1-12 months scores
measure: Satisfaction Outcomes
timeFrame: Changes from baseline score to 12 months score.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Psychiatry. Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Department of Psychiatry. Hospital Santa Creu i Sant Pau
name: Iluminada Corripio, PhD
role: PRINCIPAL_INVESTIGATOR
References: