Individualized Neuromodulation for Anhedonic Depression

Summary

This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with the overarching goals to compare competing interventions tested at each site and to combine data that will allow for the creation of an end-to-end model of anhedonic depression. By doing this, the investigators hope to gain insight and lead to the development of brain-behavior biomarkers to identify who is best suited for the different treatment options tested at each site. An additional exploratory objective is phenotyping anhedonic depression from the acquired measures.

Anhedonic patients recruited at UCSD will be randomized to one of three treatment arms to receive different forms of accelerated intermittent theta burst stimulation (aiTBS),a novel form of repetitive transcranial magnetic stimulation (rTMS) that is an FDA approved treatment for depression. These arms include: individualized accelerated iTBS (Ind-aiTBS),based on both the frequency of brain responses and electric-field (e-field) modeling of brain bioconductivity; standard accelerated iTBS (Std-aiTBS); and accelerated sham iTBS(sham). Treatment will be delivered on an accelerated schedule, over one week. Additional study sessions will occur both before and after treatment to assess for clinical, neurophysiological, and cognitive measures that will allow for both individualization of treatment and detailed assessment of the effects of the different treatment arms.

Conditions

• MDD
• Anhedonia

Interventions

DEVICE

Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)

active side magnetic coil stimulation applied to individualized target in the left dorsal lateral prefrontal cortex.

DEVICE

Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)

active side magnetic coil stimulation applied to standardized target in the left dorsal lateral prefrontal cortex.

DEVICE

Sham Accelerated Intermittent Theta Burst Stimulation (Sham)

sham side magnetic coil stimulation applied to the left dorsal lateral prefrontal cortex.

Sponsors & Collaborators

• Cornell University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Wellcome Leap Organization

  collaborator UNKNOWN

• University of California, San Diego

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2025-05-30

Completion

2025-05-30

FDA Device

Yes

Countries

• United States

Study Locations