Schizophrenia; Negative TypePhase 3NOBLE-TMSNCT06351514
An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
A Phase 3 study testing Accelerated iTBS in people with Schizophrenia; Negative Type, run by Institute of Mental Health, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Schizophrenia; Negative Type
- What is being tested?
- Accelerated iTBS
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2024to Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Institute of Mental Health
Singapore, 539747
Jenny Tay, jenny_am_tay@imh.com.sg
About this study
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
- Being tested
- Accelerated iTBS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated iTBSDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Negative symptoms
Assessed by PANSS, Negative symptoms subscale
Measured: Before treatment till Immediately post treatment.
Secondary outcomes (1)
Trend of Negative symptoms
Assessed by PANSS, Negative symptoms subscale
Measured: Before treatment till Immediately post treatment, 1 Month Post Treatment & 3 Month Post Treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Apr 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; Negative TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351514
- Sponsor's protocol ID
- 2023/00745
- Other IDs
- 2023
- Acronym
- NOBLE-TMS
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request, as approved by DSRB.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
- ClinicalTrials.gov ID
- NCT06351514
- Acronym / sponsor ID
- NOBLE-TMS / 2023/00745
- Conditions
- Schizophrenia; Negative Type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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];
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated iTBSPatients 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. | Device | – |
Primary outcome
Change of Negative symptoms
Time frame: Before treatment till Immediately post treatment.
Assessed by PANSS, Negative symptoms subscale
1 secondary outcome
Trend of Negative symptoms
Time frame: Before treatment till Immediately post treatment, 1 Month Post Treatment & 3 Month Post Treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Undecided. Upon request, as approved by DSRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Accelerated iTBS in people with Schizophrenia; Negative Type, run by Institute of Mental Health, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowei Tan (6389 2000, Xiaowei_TAN@imh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Negative symptoms (time frame: Before treatment till Immediately post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.