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Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression

Primary Purpose

Treatment Resistant Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active TBS-DLPFC
TBS-DMPFC
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring transcranial magnetic stimulation, theta burst

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or Female, between the ages of 18 and 80 at the time of screening. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information. Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). MADRS score of ≥20 at screening (Visit 1). TMS naive for one of the following areas: DLPCF or DMPFC The dose of the primary antidepressant medication (if applicable) must be stable for 6 weeks prior to baseline, and participant must agree to continue at this dose throughout the study period. In good general health, as evidenced by medical history. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Agreement to adhere to Lifestyle Considerations throughout study duration. Lifestyle Considerations: Abstain from becoming pregnant from the screening visit (Visit 1) until after the final study visit (Visit 10). Abstain from caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate) for 3 hours before the start of each dosing session until after the final TMS session. Abstain from alcohol for 24 hours before the start of each dosing session until after collection of the final MRI. Participants who use tobacco products will be instructed that use of cigarettes will not be allowed during the study. Exclusion Criteria: Pregnancy History of or current psychotic disorder or bipolar disorder Severe borderline personality disorder. Diagnosis of Intellectual Disability or Autism Spectrum Disorder Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal Urine screening test positive for illicit substances Acute suicide risk based on clinical judgement or a suicide attempt (as defined by the C-SSRS) within the past one year Any history of ECT (greater than 8 sessions) without meeting responder criteria Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT) History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma Untreated or insufficiently treated endocrine disorder. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) Contraindication to MRI (ferromagnetic metal in their body) Treatment with an investigational drug or other intervention within the study period Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO) Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score. Any other condition deemed by the PD to interfere with the study or increase risk to the participant

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active TBS-DLPFC

Active TBS-DMPFC

Arm Description

The active group will receive theta-burst TMS DLPFC stimulation.

The active group will receive theta-burst TMS DMPFC stimulation.

Outcomes

Primary Outcome Measures

Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT06052137
Brief Title
Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression
Official Title
Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

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
This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants with treatment resistant depression (TRD).
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, the investigators have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm. This study aims to further study the accelerated protocol and examine changes in neuroimaging biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
transcranial magnetic stimulation, theta burst

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TBS-DLPFC
Arm Type
Active Comparator
Arm Description
The active group will receive theta-burst TMS DLPFC stimulation.
Arm Title
Active TBS-DMPFC
Arm Type
Active Comparator
Arm Description
The active group will receive theta-burst TMS DMPFC stimulation.
Intervention Type
Device
Intervention Name(s)
Active TBS-DLPFC
Intervention Description
Participants will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro TMS system (MagVenture, Denmark).
Intervention Type
Device
Intervention Name(s)
TBS-DMPFC
Intervention Description
Participants will receive intermittent TBS to DMPFC. The DMPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the DMPFC using a MagPro TMS system (MagVenture, Denmark).
Primary Outcome Measure Information:
Title
Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation
Description
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.
Time Frame
Baseline, 1-week post-treatment-initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, between the ages of 18 and 80 at the time of screening. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information. Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). MADRS score of ≥20 at screening (Visit 1). TMS naive for one of the following areas: DLPCF or DMPFC The dose of the primary antidepressant medication (if applicable) must be stable for 6 weeks prior to baseline, and participant must agree to continue at this dose throughout the study period. In good general health, as evidenced by medical history. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Agreement to adhere to Lifestyle Considerations throughout study duration. Lifestyle Considerations: Abstain from becoming pregnant from the screening visit (Visit 1) until after the final study visit (Visit 10). Abstain from caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate) for 3 hours before the start of each dosing session until after the final TMS session. Abstain from alcohol for 24 hours before the start of each dosing session until after collection of the final MRI. Participants who use tobacco products will be instructed that use of cigarettes will not be allowed during the study. Exclusion Criteria: Pregnancy History of or current psychotic disorder or bipolar disorder Severe borderline personality disorder. Diagnosis of Intellectual Disability or Autism Spectrum Disorder Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal Urine screening test positive for illicit substances Acute suicide risk based on clinical judgement or a suicide attempt (as defined by the C-SSRS) within the past one year Any history of ECT (greater than 8 sessions) without meeting responder criteria Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT) History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma Untreated or insufficiently treated endocrine disorder. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) Contraindication to MRI (ferromagnetic metal in their body) Treatment with an investigational drug or other intervention within the study period Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO) Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Bassano
Phone
650-736-2233
Email
nbassano@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiegel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Bassano
Email
nbassano@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open Label - Personalized Therapeutic Neuromodulation for Anhedonic Depression

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