An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms

NCT06351514 | Recruiting Phase 3

• 1 other identifier: 2023/00745
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Negative Type

Outcome Measures

Primary Outcomes (1)

• Change of Negative symptoms

  Assessed by PANSS, Negative symptoms subscale

  Before treatment till Immediately post treatment.

Secondary Outcomes (1)

• Trend of Negative symptoms

  Before treatment till Immediately post treatment, 1 Month Post Treatment & 3 Month Post Treatment.

Interventions

Accelerated iTBS DEVICE

Patients will be assigned to receive iTBS over the left dorsolateral prefrontal cortex or Frontal Medea with 5 sessions a day, every weekday for 1 week and total of 25 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 100%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions. All TBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 and ≤65 years;
• With primary diagnosis of schizophrenia or schizoaffective disorder;
• Patients experienced prominent and persistent negative symptoms \[Scale for the Assessment of Negative Symptoms (SANS) score ≥3 or Positive and Negative Symptoms Scale (PANSS)- negative subscale score ≥20\] in past 6 months;
• No clinically significant positive symptoms \[PANSS positive subscale score \<20\];
• No clinically significant depressive symptoms \[Calgary Depression Scale for Schizophrenia (CDSS) score subscale \<12\];
• Able to give consent.

You may not qualify if:

• With current misuse of or dependence on illegal drugs or alcohol;
• High Suicide risk;
• History of epileptic seizures;
• With severe brain trauma, injury or other neurological diseases;
• Metal (implants) in the skull;
• Pregnancy

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Xiaowei Tan

CONTACT

6389 2000; Xiaowei_TAN@imh.com.sg

Hasvinjit Kaur

CONTACT

6389 2000; HKG_SINGH@imh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

SG (1)