SchizophreniaNCT06003036
Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
A study testing transcranial magnetic stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Deepak K. Sarpal, M.D. at 1 site in United States.
Trial summary
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 12 Jan 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- age 18-65 years
- at least 4 months of clozapine treatment
- history of at least 2 failed antipsychotic trials
- competency and willingness to sign informed consent
- A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
Who cannot join
- Serious neurologic or medical condition/treatment that impacts the brain
- a significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
- pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- history of treatment with electroconvulsive therapy
- contraindications for magnetic resonance imaging (e.g., a pacemaker)
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- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder
- seizure disorder or prior history of seizures on clozapine
- patients taking both bupropion and clozapine
- prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration
- Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- sham stimulation, transcranial magnetic stimulation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham stimulationDevice
sham delivery of transcranial magnetic stimulation
transcranial magnetic stimulationDevice
accelerated intermittent theta burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| iTBS, then Sham | Experimental | Not described Receives: Device: sham stimulation; Device: transcranial magnetic stimulation |
| Sham, then iTBS | Experimental | Not described Receives: Device: sham stimulation; Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in brain functional connectivity within the prefrontal cortex
Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)
Measured: 1 hour
change in activation of the working memory network
Examine whether accelerated intermittent theta burst stimulation (iTBS) is associated with functional magnetic resonance imaging (fMRI)-based changes in activation of the working memory network during AX-continuous performance task engagement
Measured: 1 hour
Secondary outcomes (1)
explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios
In exploratory analyses we will compare change in dorsolateral prefrontal cortex-basal forebrain functional connectivity and change in working memory network activation in relation to plasma n-desmethylclozapine/clozapine ratios.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Dec 2023
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepak K. Sarpal, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Deepak K. Sarpal, M.D., University of Pittsburgh
- Investigators
- Deepak K Sarpal, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003036
- Sponsor's protocol ID
- STUDY23050056
- Other IDs
- R21MH134128
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
- ClinicalTrials.gov ID
- NCT06003036
- Acronym / sponsor ID
- STUDY23050056
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Deepak K. Sarpal, M.D.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 21 Aug 2023 (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.
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS, then Sham | Experimental | Device: sham stimulation, Device: transcranial magnetic stimulation |
| Sham, then iTBS | Experimental | Device: sham stimulation, Device: transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- age 18-65 years
- at least 4 months of clozapine treatment
- history of at least 2 failed antipsychotic trials
- competency and willingness to sign informed consent
Key exclusion criteria (11 listed)
- Serious neurologic or medical condition/treatment that impacts the brain
- a significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
- pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- history of treatment with electroconvulsive therapy
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 |
|---|---|---|
| sham stimulationsham delivery of transcranial magnetic stimulation | Device | Sham, then iTBS, iTBS, then Sham |
| transcranial magnetic stimulationaccelerated intermittent theta burst stimulation | Device | Sham, then iTBS, iTBS, then Sham |
Primary outcome
change in brain functional connectivity within the prefrontal cortex
Time frame: 1 hour
Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)
change in activation of the working memory network
Time frame: 1 hour
Examine whether accelerated intermittent theta burst stimulation (iTBS) is associated with functional magnetic resonance imaging (fMRI)-based changes in activation of the working memory network during AX-continuous performance task engagement
1 secondary outcome
explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. de-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
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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.
Deepak K Sarpal, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Schizophrenia and Schizoaffective Disorder, run by Deepak K. Sarpal, M.D. at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in brain functional connectivity within the prefrontal cortex (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 10 Aug 2026.