NCT06003036

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
1mo left

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2023Jul 2026

First Submitted

Initial submission to the registry

August 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

August 8, 2023

Last Update Submit

April 6, 2026

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    1 hour

Secondary Outcomes (1)

  • explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios

    1 month

Study Arms (2)

iTBS, then Sham

EXPERIMENTAL
Device: sham stimulationDevice: transcranial magnetic stimulation

Sham, then iTBS

EXPERIMENTAL
Device: sham stimulationDevice: transcranial magnetic stimulation

Interventions

sham stimulationDEVICE

sham delivery of transcranial magnetic stimulation

Sham, then iTBSiTBS, then Sham
transcranial magnetic stimulationDEVICE

accelerated intermittent theta burst stimulation

Sham, then iTBSiTBS, then Sham

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
  • age 18-50 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Western Psychiatric Hospital/University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Deepak K Sarpal, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tori Blazinski

CONTACT

412-246-5618blazinskit2@upmc.edu

Deepak Sarpal

CONTACT

sarpaldk@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 21, 2023

Study Start

December 1, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

de-identified individual participant data to the National Institute of Mental Health (NIMH) data archive

Locations

US(1)