Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

Not Applicable

Recruiting

• Conditions: Negative Symptoms in Schizophrenia; Repetitive Transcranial Magnetic Stimulation; Schizophrenia; Cognitive Impairment; Dorsolateral Prefrontal Cortex

• Registration Number: NCT05599373
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.

Detailed Description

The study will be a randomized, double-blind trial comparing active rTMS over bilateral DLPFC vs. active rTMS over left DLPFC vs. sham rTMS delivered over DLPFC an 4-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 20 sessions of either active rTMS over left DLPFC or bilateral DLPFC or placebo treatments.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 .
• Age between 18 and 60.
• Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥4.
• All patients were in stable clinical conditions (reduction rate of PANSS score<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.

Exclusion Criteria

• Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension).
• Unstable clinical condition (e.g., being aggressive and uncooperative).
• Current substance abuse.
• Any other psychiatric diagnosis.
• Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
• Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment	Baseline and 4 weeks	The Assessment of Negative Symptoms(SANS) is a standardized assessment utilizing a 6-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms. It consists of 19 items assessing five symptoms of the negative dimension: Affect flattening, alogia, avolition-apathy, anhedonia-asociality, and poor attention.
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment	Baseline and 4 weeks	The MATRICS Consensus Cognitive Batteryis a standardized rating tool to assess the severity of the subject's cognitive symptoms, which consisted of seven domains and the total score: speed of processing, attention/vigilance, working memory, visual learning, verbal learning, reasoning/problem solving, and social cognition.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment	Baseline and 4 weeks	The Positive and Negative Syndrome Scale(PANSS)-Negative Subscale is a valid assessment utilizing a 7 items, 7-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms.
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment	Baseline and 4 weeks	The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a single item, 7-point scale with which the clinician rates the severity of the subject's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.
Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment	Baseline and 4 weeks	Calgary Depression Scale for Schizophrenia (CDSS) is a nine item structures interview scale, in which each item has a four point measure, which has been specifically developed to assess depression in schizophrenics.

Trial Locations

Locations (1)

Shanghai Xuhui Mental Health Center; 🇨🇳 Shanghai, Shanghai, China