Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04785456
Other study ID # 131/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.


Description:

Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist 2. Between the ages of 18-60 years 3. Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD. 4. On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study. 5. Baseline score of >/=4 on the scale for suicidal ideation (SSI). Exclusion Criteria: 1. Currently pregnant or intending to be pregnant during the duration of the study 2. Bipolar disorder, any psychotic disorder or current psychotic symptoms 3. Previous rTMS treatment 4. Known active seizure disorder, significant head injury with an imaging verified lesion 5. Unstable medical illness 6. Presence of cardiac pacemaker, intracranial implant, or metal in the cranium 7. Participants taking > 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.

Study Design


Intervention

Device:
Active TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Sham TBS
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Scale for Suicidal Ideation Remission A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome. Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary Change in Scale for Suicidal Ideation Change A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome. Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary Change in Columbia - Suicide Severity Rating Scale Change An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Secondary 17-item Hamilton Rating Scale for Depression (HRSD-17) Change A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Secondary Visual Analogue Scale for Opioid Cravings Change A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome. Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Secondary Timeline Followback Change Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome. Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4