Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351514
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
An Open-Label Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
Sponsor:
Institute of Mental Health Singapore
Organization:
Institute of Mental Health Singapore
Study Overview
Official Title:
An Open-Label Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOBLE-TMS
Brief Summary:
Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation iTBS to treat negative symptoms in schizophrenia In this study we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms
We propose a pragmatic open label and single arm clinical trial Forty patients with diagnosis of schizophrenia who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days Participants will be followed up immediately 1 month and 3 months after the end of treatment Clinical assessment includes BNSS The Brief Negative Symptom Scale SANS Scale for the assessment of negative symptoms SAPS Scale for the assessment of positive symptoms PANSS Positive and Negative Symptoms Scale MoCA Montreal Cognitive Assessment scale CDSS Calgary Depression Scale for Schizophrenia SDS Sheehans disability scale and EQ-5D The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS negative symptoms subscale immediately after the treatment
This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need
We propose a pragmatic open label and single arm clinical trial Forty patients with diagnosis of schizophrenia who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days Participants will be followed up immediately 1 month and 3 months after the end of treatment Clinical assessment includes BNSS The Brief Negative Symptom Scale SANS Scale for the assessment of negative symptoms SAPS Scale for the assessment of positive symptoms PANSS Positive and Negative Symptoms Scale MoCA Montreal Cognitive Assessment scale CDSS Calgary Depression Scale for Schizophrenia SDS Sheehans disability scale and EQ-5D The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS negative symptoms subscale immediately after the treatment
This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None