RTMS Feasibility Study on Adolescent Depression Stimulation

NCT06126198 | Completed

• 1 other identifier: Teen-TMS_UU2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

Conditions

Major Depressive Disorder; Unipolar Depression; Bipolar Depression

Keywords

repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Inclusion rate -

  Participant inclusion during the course of the study

  two years

• Attrition rate

  Participant drop-off during the course of the study

  two years

Secondary Outcomes (2)

• CGAS (Children's Global Assessment Scale) score

  4 weeks, 6 weeks

• MADRS (Montgomery and Asberg Depression Rating Scale) score

  at Baseline, 4 weeks, 6 weeks

Study Arms (1)

Active treatment

EXPERIMENTAL

Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS induces local electrical currents in the stimulated neurons and has been shown to induce long-term inhibition or excitation of groups of neurons in treated cortical areas

Active treatment

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent from parents and legal guardian
• Age 13-19 years
• Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID)
• Treatment with at least two SSRIs at an adequate dose for at least 8 weeks

You may not qualify if:

• Epilepsy or medical history of seizures
• Conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil
• Implanted device that is activated or controlled in any way by physiological signals
• Implanted medication pumps
• Intracardiac lines (even if removed)
• Active substance use disorder
• Treatment with any medication that could lower the threshold for seizures
• Usage of benzodiazepines both as prescribed drug and illegal use
• Any condition that seriously increases the risk of non-compliance or loss of follow-up

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University

Uppsala, 75236, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder; Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label study

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)