Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07258914

Feasibility and Efficacy of rTMS in Depression in Patients With Autism Spectrum Disorder (ASD)

Depression is a common complication of Autism Spectrum Disorder (ASD): it is four times more prevalent in people with ASD than in the general population.

However, treating depression in people with ASD is complicated by the lack of guidelines. Antidepressants appear to be less effective and less well tolerated than in the general population.

rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates the brain in a painless and non-invasive way. This technique is well tolerated and has very few side effects (headaches, fatigue). It is now used routinely in clinical practice to treat resistant depression, with satisfactory results.

A few studies using rTMS in depression in people with ASD have shown encouraging results and avenues for improvement.

It could therefore be interesting to conduct a therapeutic study with rTMS on depression in people with ASD, following the avenues for improvement proposed by previous studies.

The main objective is to evaluate the effectiveness of rTMS in depressed patients with ASD by looking at changes in mood before and after treatment. The investigator will also look at the effects on executive and attentional functions and repetitive behaviors, as well as treatment tolerance.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Depression is a common comorbidity of autism spectrum disorder (ASD). Its prevalence is four times higher than in the neurotypical population, with specific symptoms, particularly irritability. However, the management of major depressive episodes (MDEs) in patients with ASD is complicated by the lack of specific recommendations for depression in ASD, while the effectiveness of pharmacological treatments is limited in this context.

rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates brain tissue in a non-invasive and painless manner, with good tolerance and few side effects. In the neurotypical population, it is used routinely in clinical practice to treat resistant EDMs, with satisfactory results.

To date, there are few studies on the treatment of depression in patients with ASD using TMS. Although these studies have certain limitations, they have shown encouraging results. These two studies are open-label studies involving fewer than 20 patients, but they show a significant improvement in depression scales before and after TMS treatment. The stimulation parameters (stimulation target: left dorsolateral prefrontal cortex, 15 to 30 sessions at a rate of one session per day, stimulation frequency of 10Hz for the first study and 50Hz in theta burst for the second) are those used in studies on depression in neurotypical depressed patients. In addition to the small sample size, these open-label studies have limitations in terms of parameter potentiation (target localisation, number of pulses per session and per day). It may therefore be worthwhile conducting a preliminary study to assess the feasibility and efficacy of rTMS in depressed ASD patients using an innovative accelerated, high-dose intermittent theta burst stimulation protocol with precise targeting of the stimulation site using neuronavigation and a detailed assessment of clinical depression in ASD, including irritability. Furthermore, an improvement in cognitive functions has been observed in neurotypical depressed patients receiving rTMS at the dorsolateral prefrontal cortex. It would therefore be interesting to study the impact of rTMS on executive and attentional functions using these innovative stimulation parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with a diagnosis of ASD validated by a psychiatrist or line 2
  • Patient aged 18 to 65...
  • Patients suffering from EDM (MADRS greater than 20)
  • No change in treatment in the month prior to inclusion
  • Patients affiliated with or entitled to social security
  • Patients who have received informed information about the study and have signed a consent form to participate in the study

Exclusion criteria

  • Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder)
  • Pregnancy at the time of inclusion
  • Patients with contraindications to rTMS and MRI (history of epilepsy, neurological stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metal fragments in the eyes, claustrophobia)
  • Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty, persons hospitalised under compulsion (SDT, SDRE).

Treatment and study plan

rTMS

Other

Patients receive 20 sessions of intermittent theta burst stimulation of the left CPFDL over 5 days (4 sessions of 10 minutes per day with a 50-minute interval between each session). The CPFDL is located using neuronavigation, which requires an MRI scan (without contrast agent injection) before the sessions.

rTMS treatment with intermittent Theta Burst (ITBS)

Other

rTMS (iTBS) treatment with stimulation of the left dorsolateral prefrontal cortex (DLPFC). Localization is performed using neuronavigation. There are four 10-minute sessions per day, with a 50-minute interval between each session.

Primary outcomes

  1. Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.

    Time frame: From enrollment to the end of the data collecting process : 2 months.

    Upon inclusion, patients are assessed for mood using the MADRS.(inclusion criterion: MADRS>20).

    The primary endpoint is the change in MADRS score one week after the end of treatment and one month after the end of treatment.

    score ranges from 0 to 60. The higher the score, the more severe the disorder is.

Secondary outcomes

  1. Assessment of changes in irritability before versus after treatment

    Time frame: from enrolment to one month after the end of the rTMS treatment

    Irritability is assessed with the Angst scale. A global score of 10 or more indicates irritability.

  2. assessment of changes in attention functions

    Time frame: From enrolment to one week then 1 month after the end of the rTMS treatment

    Attentional functions are assessed using two subtests of the TAP (Test of Attentional Performance):

    • sustained attention : The test measures the ability to maintain attention over the long term with a high density of target stimuli.
    • Split Attention : The test explores the Ability to focus attention on two tasks simultaneously.
  3. Evolution of any side effects

    Time frame: During the treatment, at each stimulation time

    Assessment of side effects of rTMS using the UKU scale

  4. Assement of change in repetitive behaviors before versus after treatment

    Time frame: from enrolment and 1 month after the end of rTMS treatment

    BPI-1 (Behavior Problems Inventory) is an informant-based behaviour rating instrument that was designed to assess maladaptive behaviours in individuals with ASD. Its items fall into one of three sub-scales: Self-injurious Behavior (14 items), Stereotyped Behavior (24 items), and Aggressive/Destructive Behavior (11 items). Each item is rated on a frequency scale (0 = never to 4 = hourly), and a severity scale (0 = no problem to 3 = severe problem).

  5. assessment of changes in mood aspects in terms of psychomotor decline before versus after rTMS treatment

    Time frame: from enrolment to one week then one month after the end of the rTMS treatment

    psychomotor decline is assessed with the depressive decline scale (ERD).This tool contains 14 items that describe the motor, verbal, ideational, hedonic, and cognitive behavior of depressed individuals. Each item is rated from 0 to 4 ( 1 expressing doubt about the pathological nature of the observed phenomenon).

  6. assessment of changes in mood aspects in terms of depression before versus after rTMS treatment

    Time frame: From enrolment to one week then one month after the end of the rTMS treatment

    Depression is assessed with the Patient Health Questionnaire - 9 items (PHQ-9) This is a brief tool used to assess and measure the severity of depression. Items are rated on a scale from 0 to 3. The maximum score is 27 (major depression)

  7. Assessment of changes in executive functions before versus after rTMS treatment

    Time frame: From enrolment and 1 month after the end of rTMS treatment

    The TMT (Trial Making Test) measures attention, visual screening ability, and processing speed. The Trail Making Test is scored by how long it takes to complete the test

  8. Assessment of changes in executive functions before versus after rTMS treatment

    Time frame: From enrolment and 1 month after the end of rTMS treatment

    The Stroop test measures recognition reaction times to color stimuli, evaluating psychomotor speed and cognitive flexibility.

  9. Assessment of changes in executive functions before versus after rTMS treatment

    Time frame: From enrolment and 1 month after the end of rTMS treatment

    The GO/NO GO task measures the ability to inhibit and the control of impulses

Sponsors and collaborators

Lead sponsor

Hospital Center Guillaume Régnier

Other

Registry information

Official study title

Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)

Acronym: DEPASS'R

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.