Accelerated Theta Burst Stimulation for Negative Symptoms in Schizophrenia
An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
This study is testing a new brain stimulation treatment to see if it can help adults with schizophrenia who still have ongoing negative symptoms feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Mental Health, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06351514 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of accelerated intermittent Theta Burst Stimulation (iTBS) as a treatment for patients with schizophrenia who experience persistent negative symptoms. The study will recruit 40 adults aged 21 to 65 who have stabilized from acute psychotic episodes but continue to suffer from significant negative symptoms. Participants will undergo an open-label treatment protocol to assess the efficacy of iTBS in improving their condition. The trial aims to provide a novel neuromodulatory approach to a challenging aspect of schizophrenia treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 65 with a primary diagnosis of schizophrenia or schizoaffective disorder and prominent negative symptoms.
Not a fit: Patients with current substance dependence, high suicide risk, or significant positive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from persistent negative symptoms of schizophrenia.
How similar studies have performed: Preliminary evidence from other trials suggests that intermittent Theta Burst Stimulation may be effective, making this approach promising yet still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- Institute of Mental Health — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Xiaowei Tan
- Email: Xiaowei_TAN@imh.com.sg
- Phone: 6389 2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.