Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Treatment Resistant Depression Clinical Trial

— TRANSCEND  

Official title:

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423430
• Other study ID #: ABT-CIP-10494
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 2029

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: Bradley White
• Phone: +6164432812
• Email: bradley.white[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Description:

The aim of this prospective, multi-centered, double-blind, randomized, delayed-stimulation/ Sham-stimulation controlled 12-month study is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.

In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2029
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.

The patient must be in a major depressive episode for = 12 months or have had at least 3 lifetime depressive episodes.

The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.

Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit

Exclusion Criteria:

Pregnant or those who plan to become pregnant during study

Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol.

Current or lifetime history of psychotic features in any Major Depressive Episode.

Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.

Significant acute suicide risk.

Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).

Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.

Treatment with another investigational device or investigational drugs.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Device:
• Sham-stimulation
Sham-stimulation
• Active-stimulation
Active DBS

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	CHI St. Luke's Health Baylor College of Medicine Med. Ctr	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	UCLA Department of Psychiatry	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Mount Sinai Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California at Davis	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	USF Health	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale (MADRS) Rate of Response	The number of months in response divided by the total available months within the endpoint evaluation period. Response is defined as having at least a 50% reduction from baseline in MADRS total score	12 months
Secondary	MADRS Response Rates	Defined as = 50% decrease in MADRS from baseline.	12 months
Secondary	Change in MADRS Score	Change in MADRS score over time	12 months
Secondary	MADRS Remission Rates	Measured by MADRS, score = 9	12 months