Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-02

Study Completion Date

2018-06-22

Brief Summary

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This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.

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Detailed Description

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Conditions

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Depression Depressive Disorder Depressive Episode Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DLPFC-DLPFC

15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over DLPFC

Group Type ACTIVE_COMPARATOR

active rTMS over DLPFC

Intervention Type DEVICE

15 sessions of active rTMS over DLPFC

Add-on active rTMS over DLPFC

Intervention Type DEVICE

15 additional sessions of active rTMS over DLPFC

DLPFC-LPC

15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over LPC

Group Type EXPERIMENTAL

active rTMS over DLPFC

Intervention Type DEVICE

15 sessions of active rTMS over DLPFC

Add-on active rTMS over LPC

Intervention Type DEVICE

15 additional sessions of active rTMS over LPC

DLPFC-SHAM

15 sessions of active rTMS over DLPFC + 15 sessions of sham rTMS over DLPFC or LPC

Group Type SHAM_COMPARATOR

active rTMS over DLPFC

Intervention Type DEVICE

15 sessions of active rTMS over DLPFC

Add-on sham rTMS

Intervention Type DEVICE

15 additional sessions of sham rTMS over DLPFC or LPC

Interventions

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active rTMS over DLPFC

15 sessions of active rTMS over DLPFC

Intervention Type DEVICE

Add-on active rTMS over DLPFC

15 additional sessions of active rTMS over DLPFC

Intervention Type DEVICE

Add-on active rTMS over LPC

15 additional sessions of active rTMS over LPC

Intervention Type DEVICE

Add-on sham rTMS

15 additional sessions of sham rTMS over DLPFC or LPC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* fulfilled criteria for unipolar major depressive disorder for at least four weeks
* did not respond to a minimum of one or did not tolerate a minimum of two antidepressants in the current episode

Exclusion Criteria

* metal in the brain or the skull
* cardiac pacemaker or intracardiac lines
* medication infusion devices
* heart or brain surgery
* pregnancy
* substance induced depression
* history of substance abuse
* psychotic episodes
* bipolar disorder
* anorexia
* posttraumatic stress disorder (current or within the last 12 months)
* claustrophobia
* any condition resulting in increased intracranial pressure
* traumatic brain injury
* history of epilepsy
* cerebral aneurysms
* dementia
* Morbus Parkinson
* Chorea Huntington
* multiple sclerosis
* stroke or transient ischemic attack (within the last 2 years)
* previous antidepressive treatment with rTMS, electroconvulsive therapy (within the last 3 months), vagus nerve stimulation or deep brain stimulation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No