Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02046330 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
A NA study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by The University of Texas Health Science Center, Houston.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02046330: Active NA study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by The University of Texas Health Science Center, Houston.
NCT02046330 is a NA study of Major Depressive Disorder and Treatment-Resistant Depression that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 16 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02046330, a NA study of Major Depressive Disorder and Treatment-Resistant Depression, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
We will assess individual patient response, measured by standardized patient and clinician ratings of depression severity, under blinded conditions. Prospective ratings using validated and reliable measures of symptoms, quality of life and safety will be employed. We will assess safety for all subjects by monitoring any adverse events.
Conditions Studied
Interventions
- DEVICE Deep Brain Stimulation Model 3387 Model 3389
Study Locations (1)
Texas
- UT Center of Excellence on Mood Disorders - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What the registry record for NCT02046330 still lists
NCT02046330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation Model 3387 Model 3389 is the first listed.
NCT02046330 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02046330 about?
NCT02046330 is a clinical study titled "Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression". 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...
What is the current status of trial NCT02046330?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2013-12-16. Estimated completion is 2027-04-01.
What conditions does trial NCT02046330 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT02046330?
The interventions under investigation include: Deep Brain Stimulation Model 3387 Model 3389 (DEVICE).
Who is sponsoring clinical trial NCT02046330?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02046330 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02046330's enrollment target sits among peer trials
16 257th of 282 higher than 23 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Taking Action for College Students
RECRUITING · NA
-
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
RECRUITING · NA
-
Neural Correlates of Stress and Perceived Control in Adolescent Depression
RECRUITING · NA
-
Positive Processes and Transition to Health (PATH)
RECRUITING · NA
-
Getting Out of the House: Using Behavioral Activation to Increase Community Participation
RECRUITING · NA
-
Amygdala Neurofeedback for Depression - Large Scale Clinical Trial
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI