Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

Back to results

Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

sham stimulation

transcranial magnetic stimulation

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

UPMC Western Psychiatric Hospital/University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

iTBS, then Sham

Sham, then iTBS

Arm Description

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT06003036

First Posted

August 8, 2023

Last Updated

August 25, 2023

Sponsor

Deepak Sarpal

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT06003036

Brief Title

Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

Official Title

Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Deepak Sarpal

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

iTBS, then Sham

Arm Type

Experimental

Arm Title

Sham, then iTBS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

sham stimulation

Intervention Description

sham delivery of transcranial magnetic stimulation

Intervention Type

Device

Intervention Name(s)

transcranial magnetic stimulation

Intervention Description

accelerated intermittent theta burst stimulation

Primary Outcome Measure Information:

Title

change in brain functional connectivity within the prefrontal cortex

Description

Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)

Time Frame

1 hour

Title

change in activation of the working memory network

Description

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

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tori Blazinski

Phone

412-246-5618

Email

blazinskit2@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Deepak Sarpal

Email

sarpaldk@upmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepak K Sarpal, M.D.

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Western Psychiatric Hospital/University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tori Blazinski

Email

blazinskit2@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Schizophrenia, Schizoaffective Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial