RECRUITING

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

Conditions

Major Depressive Disorder Treatment Resistant Depression Deep Brain Stimulation Depression ECT TNS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

Official Title

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant

Quick Facts

Study Start:2013-12-16

Study Completion:2027-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02046330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity. 2. Age 22 - 70 years. 3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items 4. Global Assessment of Function (GAF) score of 45 or less. 5. A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior). 6. Failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials ( equal\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist). 7. Able to comply with the operational and administrative requirements of participation in the study. 8. Able to give written informed consent 9. On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. 10. Good general health. No changes in medication treatment during participation in study.	1. Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis. 2. Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function. 3. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI). 4. Any previous surgery to destroy the region of the brain that will be the target of treatment. 5. Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. 6. Refusal of an adequate trial of ECT. 7. History of stimulation intolerance in any area of the body. 8. Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months. 9. Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required. 10. History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder. 11. Imminent risk of suicide 12. Participation in another drug, device, or biologics trial within the preceding 30 days 13. Presence of a condition requiring routine MRIs. 14. Presence of a condition requiring diathermy. 15. Subject is on anticoagulant medication. 16. Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators). 17. Terminal illness associated with expected survival of \<12 months.

Inclusion Criteria

Exclusion Criteria

1. Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity.
2. Age 22 - 70 years.
3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items
4. Global Assessment of Function (GAF) score of 45 or less.
5. A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior).
6. Failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials ( equal\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
7. Able to comply with the operational and administrative requirements of participation in the study.
8. Able to give written informed consent
9. On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study.
10. Good general health. No changes in medication treatment during participation in study.

1. Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis.
2. Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
3. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
4. Any previous surgery to destroy the region of the brain that will be the target of treatment.
5. Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
6. Refusal of an adequate trial of ECT.
7. History of stimulation intolerance in any area of the body.
8. Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.
9. Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required.
10. History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder.
11. Imminent risk of suicide
12. Participation in another drug, device, or biologics trial within the preceding 30 days
13. Presence of a condition requiring routine MRIs.
14. Presence of a condition requiring diathermy.
15. Subject is on anticoagulant medication.
16. Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).
17. Terminal illness associated with expected survival of \<12 months.

Contacts and Locations

Study Contact

Mario Farag, MD

CONTACT

713-486-2881

mario.f.farag@uth.tmc.edu

Courntey Vecera

CONTACT

713-486-2623

courtney.vecera@uth.tmc.edu

Principal Investigator

Jair C Soares, MD, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Joao Quevedo, MD, PhD

STUDY_DIRECTOR

The University of Texas Health Science Center, Houston

Giovana Zunta Soares, MD

STUDY_DIRECTOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

UT Center of Excellence on Mood Disorders

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Jair C Soares, MD, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston
Joao Quevedo, MD, PhD, STUDY_DIRECTOR, The University of Texas Health Science Center, Houston
Giovana Zunta Soares, MD, STUDY_DIRECTOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-12-16

Study Completion Date2027-04-01

Study Record Updates

Study Start Date2013-12-16

Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

Deep Brain Stimulation
Treatment Resistant Depression
Major Depressive Disorder
Depression
ECT
TNS

Additional Relevant MeSH Terms

Major Depressive Disorder
Treatment Resistant Depression