Suspended

A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression

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What is being tested

Libra Deep Brain Stimulation System

+ Libra Deep Brain Stimulation System

Device
Who is being recruted

Mental Disorders+2

+ Mood Disorders

+ Depressive Disorder, Major

From 21 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Last updated: April 26, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.

NCT01801319
Principal SponsorAbbott Medical Devices
Last updated: April 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersMood DisordersDepressive Disorder, MajorDepressive DisorderDepressive Disorder, Treatment-Resistant

Criteria

6 inclusion criteria required to participate
Current episode > 12 months duration
Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
First episode onset before age 45
Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve >= 25%
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13 exclusion criteria prevent from participating
A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria
Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon
Alcohol, medication, or illegal substance dependence within last 12 months
Co-morbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Libra Deep Brain Stimulation System is implanted and activated post implantation

Group II

Sham
The Libra DBS System is implanted and not activated

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Toronto General Hospital

Toronto, CanadaOpen Toronto General Hospital in Google Maps
SuspendedOne Study Center