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Sham-absTBS treatment sequence arm for Depression (CogniTReaD Trial)

N/A

Recruiting

Led By Amer M. Burhan, MBChB, MSc

Research Sponsored by Ontario Shores Centre for Mental Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, week 2, week 3, week 6, week 8, and week 10

Awards & highlights

CogniTReaD Trial Summary

This trial will investigate the effectiveness of a new treatment called accelerated bilateral sequential theta burst stimulation (absTBS) for older adults with treatment-resistant depression. The study will compare absTBS with a fake

Who is the study for?

This trial is for individuals aged 50 or older who have treatment-resistant depression of at least moderate severity. It aims to test if a new therapy, absTBS, can improve mood and cognitive functions in these patients.Check my eligibility

What is being tested?

The study compares active accelerated bilateral sequential theta burst stimulation (absTBS), a potential new treatment for depression, with a sham (inactive) treatment to see which is more effective in improving symptoms of depression and cognitive function.See study design

What are the potential side effects?

While the specific side effects are not detailed here, participants will be monitored for any adverse reactions to the treatments. Side effects could range from discomfort at the stimulation site to changes in mood or cognition.

CogniTReaD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, week 2, week 3, week 6, week 8, and week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1, week 2, week 3, week 6, week 8, and week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 3, week 6, week 8, and week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events (AE)

Change in Dual-task Cost

Change in Hamilton Depression Rating Scale 17 (HAMD-17) score

Secondary outcome measures

Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score

Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score

Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score

+16 more

CogniTReaD Trial Design

2Treatment groups

Experimental Treatment

Group I: absTBS-sham treatment sequence armExperimental Treatment1 Intervention

Those assigned to the accelerated bilateral sequential theta burst stimulation (absTBS)-sham arm shall receive the blinded active absTBS treatment at Week 1. At Week 3, they shall receive the blinded sham treatment.

Group II: Sham-absTBS treatment sequence armExperimental Treatment1 Intervention

In the sham-absTBS arm, the blinded sham treatment shall be administered at Week 1. The blinded active absTBS treatment shall be given at Week 3.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ontario Shores Centre for Mental Health SciencesLead Sponsor

12 Previous Clinical Trials

2,084 Total Patients Enrolled

4 Trials studying Depression

505 Patients Enrolled for Depression

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,551,253 Total Patients Enrolled

35 Trials studying Depression

9,472 Patients Enrolled for Depression

Amer M. Burhan, MBChB, MScPrincipal InvestigatorOntario Shores Centre for Mental Health Sciences and University of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"Affirmative. Information sourced from clinicaltrials.gov affirms that recruitment is ongoing for this trial, which was first listed on April 1st, 2024 and had its latest update on March 14th, 2024. The study aims to enroll a total of 54 participants at one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is presently enrolling volunteers. The clinical trial was first made public on April 1st, 2024 and had its most recent update on March 14th, 2024. Recruitment aims to secure the participation of 54 individuals at a single site for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression

2024. "Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06323486.