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PRISM Neurofeedback Training for MDD Anhedonic Patients

Primary Purpose

Depression, Anhedonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active RS-EFP
Sham RS-EFP
Sponsored by
GrayMatters Health Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 22 to 65 Any gender and all ethnic/racial origins Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5), with HDRS-21 ≥17 and SHAPS- score ≥25. MDD diagnosis will be determined via the Neuropsychiatric Interview (SCID-V for DSM-5). Fall within parameters as defined in the Retrospective stage, and/or anhedonic subtype of MDD Right-handed (Chapman and Chapman 1987) Fluency in written and spoken English Ability to give signed, informed consent either written or electronic (via REDCap eConsent) Normal or corrected-to-normal vision and hearing Ability to adhere to the study schedule Exclusion Criteria: A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder. Lifetime diagnosis of autism or intellectual disability at discretion of investigator. Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit. Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night at equivalent daily dose of up to 3 mg. Current diagnosis of posttraumatic stress disorder (PTSD). Any psychotropic medication other than a stable dose of antidepressants, e.g., selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs). Because of the focus on RS, any past or current use of DA (Dopamine Agonist)-acting drugs (e.g., bupropion, stimulants, low doses of anti-psychotics used as an augmentation strategy). Also, exclude metformin or any other compound with DA effects. Any change in - or initiation of - SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy (see also exclusion #10) during the study duration. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period. Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based MDD psychotherapy (Cognitive Behavior Therapy [CBT], Behavioral Activation Therapy, etc.); continuation of established maintenance supportive therapy will be permitted. A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder. Any unstable medical condition, as per the clinical judgment of the investigator. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Contraindications to MRI (e.g., metal in body, claustrophobia). Hairstyles that prevent the application of the EEG net (e.g., braids, dreadlocks, corn rows, recently dyed hair)

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Arm

Control Arm

Arm Description

Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.

Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care.

Outcomes

Primary Outcome Measures

HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.

Secondary Outcome Measures

Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
The clinical global impression (CGI-I)
The CGI-I Scale - of Clinical Global Impression (Guy et.al, 1976) - is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Rated within the range of 0 to 7, lower scores indicate improved outcomes while higher scores indicate worsen outcomes.

Full Information

First Posted
April 23, 2023
Last Updated
September 14, 2023
Sponsor
GrayMatters Health Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05869708
Brief Title
PRISM Neurofeedback Training for MDD Anhedonic Patients
Official Title
Personalizing Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia Using Clinical Biomarkers for MDD Subtypes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GrayMatters Health Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample. The main questions it aims to answer are: what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy? What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia? Participants will be randomly assigned to one of two arms, Active, or Sham. During the study, participants will perform the following: Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. Perform 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months). Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care.
Intervention Type
Device
Intervention Name(s)
Active RS-EFP
Intervention Description
15 (+/- 3) active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session.
Intervention Type
Device
Intervention Name(s)
Sham RS-EFP
Intervention Description
15 (+/- 3) sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session.
Primary Outcome Measure Information:
Title
HDRS-21
Description
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
Description
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Time Frame
9 weeks
Title
HDRS-21
Description
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Time Frame
3 months
Title
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
Description
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Time Frame
3 months
Title
The clinical global impression (CGI-I)
Description
The CGI-I Scale - of Clinical Global Impression (Guy et.al, 1976) - is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Rated within the range of 0 to 7, lower scores indicate improved outcomes while higher scores indicate worsen outcomes.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 22 to 65 Any gender and all ethnic/racial origins Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5), with HDRS-21 ≥17 and SHAPS- score ≥25. MDD diagnosis will be determined via the Neuropsychiatric Interview (SCID-V for DSM-5). Fall within parameters as defined in the Retrospective stage, and/or anhedonic subtype of MDD Right-handed (Chapman and Chapman 1987) Fluency in written and spoken English Ability to give signed, informed consent either written or electronic (via REDCap eConsent) Normal or corrected-to-normal vision and hearing Ability to adhere to the study schedule Exclusion Criteria: A history of schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder. Lifetime diagnosis of autism or intellectual disability at discretion of investigator. Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit. Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night at equivalent daily dose of up to 3 mg. Current diagnosis of posttraumatic stress disorder (PTSD). Any psychotropic medication other than a stable dose of antidepressants, e.g., selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs). Because of the focus on RS, any past or current use of DA (Dopamine Agonist)-acting drugs (e.g., bupropion, stimulants, low doses of anti-psychotics used as an augmentation strategy). Also, exclude metformin or any other compound with DA effects. Any change in - or initiation of - SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy (see also exclusion #10) during the study duration. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period. Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based MDD psychotherapy (Cognitive Behavior Therapy [CBT], Behavioral Activation Therapy, etc.); continuation of established maintenance supportive therapy will be permitted. A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder. Any unstable medical condition, as per the clinical judgment of the investigator. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Contraindications to MRI (e.g., metal in body, claustrophobia). Hairstyles that prevent the application of the EEG net (e.g., braids, dreadlocks, corn rows, recently dyed hair)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liora Levi, PhD
Phone
+972509260334
Email
liora@graymatters.health
First Name & Middle Initial & Last Name or Official Title & Degree
Adar Shani
Phone
+972542347770
Email
adar@graymatters.health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Pizzagalli, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Sapperstein
Phone
484-639-5372
Email
msapperstein@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Molly Sapperstein
Phone
617-855-2247
Email
neurofeedbackstudy@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kerry J Ressler, MD
First Name & Middle Initial & Last Name & Degree
Isabelle M Rosso, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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PRISM Neurofeedback Training for MDD Anhedonic Patients

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