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Completed

NCT Number: NCT03680781

Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study

This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Palo Alto, California, 94305, United States

About this study

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 18 to 75 years of age.
  • Able to provide informed consent.
  • Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
  • prior exposure to rTMS
  • Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
  • Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
  • Participants are required to have a stable psychiatrist for the duration of study enrollment.

Exclusion criteria

  • History of MI, CABG, CHF, or other cardiac history
  • Any neurological conditions
  • History of epilepsy
  • OCD
  • Independent sleep disorder
  • Autism Spectrum Disorder

Treatment and study plan

Intermittent theta-burst stimulation (iTBS) delivered to the L-DLPFC

Device

Participants will receive iTBS to the left DLPFC and will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).

Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device.

Intermittent theta-burst stimulation (iTBS) delivered to the bilateral DLPFC

Device

Participants will receive iTBS to bilateral DLPFC. The DLPFC will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).

Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device.

Primary outcomes

  1. Change in Hamilton Depression Rating Scale 21-Item Score

    Time frame: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)

    A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression.

Secondary outcomes

  1. Change in Hamilton Rating Scale for Depression (HAMD-17)

    Time frame: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment

    The HAMD-17 is a 17-item rating scale questionnaire administered by clinicians to rate a patient's level of depression . The total scores range from 0 to 52 with higher scores indicating worse depression.

  2. Change in The Scale for Suicide Ideation

    Time frame: Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment

    A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. The total scores range from 0 to 38 with higher scores indicating greater suicidality.

  3. Change in Hamilton Rating Scale for Depression (HAMD-6)

    Time frame: Every day of stimulation on days (visits) 1, 2, 3, 4, and 5

    The HAMD-6 is a shorter, six-item version of the Hamilton Depression Rating Scale (HAMD-D) that measures core symptoms of major depressive disorder, such as depressed mood, guilt and anxiety. The total scores range from 0 to 22 with higher scores indicating worse depression.

  4. Change From Baseline Functional Connectivity Within the Default Mode Network.

    Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment

    We will assess functional connectivity as seen on resting state fMRI within the default mode network.

  5. Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.

    Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment

    We will assess functional connectivity as seen on resting state fMRI of subcallosal cingulate cortex to the default mode network.

  6. Change in Beck Depression Inventory (BDI)

    Time frame: Baseline, immediately post-treatment, 4 weeks post-treatment

    The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to measure the severity of depression symptoms. The total scores range from 0 to 63 with higher scores indicating worse depression.

  7. Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Baseline, immediate post-treatment, 4 weeks post-treatment

    The MADRS (Montgomery-Åsberg Depression Rating Scale) is a 10-item diagnostic tool used by clinicians to assess the severity of depression by scoring symptoms on a 0-60 scale with higher scores indicating worse depression.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2018
Registry last updated
Jul 22, 2026

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.

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