Clinical trial NCT06363981: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression
Official title: Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unipolar Depression
Bipolar Disorder
Keywords: depression
repetitive transcranial magnetic stimulation
dorsolateral prefrontal cortex
dorsomedial prefrontal cortex
cognitive impairment
anhedonia
sleep disorders
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Andrzej Frycz Modrzewski Krakow University
First posted: 2024-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design
Primary purpose: TREATMENT

Brief summary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.

Detailed description: Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.

Eligibility criteria: Inclusion Criteria:

* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
* Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
* The score in the Athens Insomnia Scale eight or more
* The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
* Complaining about problems with memory and concentration timely related with the onset of depression

Exclusion Criteria:

* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion

Primary outcomes:
measure: Beck Depression Inventory 2
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Froward digit span
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Language part of Addenbrooke's Cognitive Examination
timeFrame: Before intervention - four weeks after finishing intervention.
Secondary outcomes:
measure: Dimensional Anhedonia Rating Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Athens Insomnia Scale
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Pittsburgh Sleep Quality Index
timeFrame: Before intervention - four weeks after finishing intervention.
measure: Epworth Sleepiness Scale
timeFrame: Before intervention - four weeks after finishing intervention.
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: The Education of Research and Development Center, Babinski Clinical Hospital
Study officials:
affiliation: The Education of Research and Development Center, Babinski Clinical Hospital
name: Wojciech Korzeniowski, MD
role: PRINCIPAL_INVESTIGATOR
References: