NCT06351514 An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
| NCT ID | NCT06351514 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institute of Mental Health, Singapore |
| Condition | Schizophrenia; Negative Type |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2024-04-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥21 and ≤65 years; 2. With primary diagnosis of schizophrenia or schizoaffective disorder; 3. 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; 4. No clinically significant positive symptoms \[PANSS positive subscale score \<20\]; 5. No clinically significant depressive symptoms \[Calgary Depression Scale for Schizophrenia (CDSS) score subscale \<12\]; 6. Able to give consent. Exclusion Criteria: 1. With current misuse of or dependence on illegal drugs or alcohol; 2. High Suicide risk; 3. History of epileptic seizures; 4. With severe brain trauma, injury or other neurological diseases; 5. Metal (implants) in the skull; 6. Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06351514 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Schizophrenia; Negative Type. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06351514 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06351514 currently recruiting?
Yes, NCT06351514 is actively recruiting participants. Contact the research team at Xiaowei_TAN@imh.com.sg for enrollment information.
Where is the NCT06351514 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06351514 clinical trial?
NCT06351514 is sponsored by Institute of Mental Health, Singapore. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.