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NCT01798407 · ClinicalTrials.gov registry record · NA
DBS of the Lateral Habenula in Treatment-Resistant Depression
A NA study of Treatment-Resistant Major Depressive Disorder, sponsored by Wayne Goodman MD.
- Active
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01798407: Active NA study of Treatment-Resistant Major Depressive Disorder, sponsored by Wayne Goodman MD.
NCT01798407 is a NA study of Treatment-Resistant Major Depressive Disorder that is active but no longer recruiting, run by Wayne Goodman MD. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01798407, a NA study of Treatment-Resistant Major Depressive Disorder, is active but no longer recruiting, sponsored by Wayne Goodman MD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study will investigate the safety, tolerability, and benefit of bilateral deep brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD), or bipolar disorder (BD) I. Six adult subjects with TRD will be treated in this single-site study at Baylor College of Medicine; subjects will be chronically symptomatic with significant functional disability, and will have demonstrated resistance to standard somatic and pharmacotherapeutic treatments. The primary outcome measure will be the change in the 17-item Hamilton Depression Rating Scale (HDRS\^17) six months after the commencement of stimulation.
Primary Outcome
'Response' is categorically defined as a ≥ 50% reduction in the HDRS17 score relative to the baseline assessment. 'Remission' is defined as an absolute HDRS17 score \< 8. Study success criteria will be defined as ≥ 3 of the 6 patients meeting the individual subject success criteria of response or remission by HDRS17 score at the 6 month time point.
Conditions Studied
Interventions
- DEVICE Activa Tremor Control Sys (DBS Implant)
- OTHER Randomized, staggered withdrawal phase
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-02 |
| Est. Completion | 2026-08 |
| Phase | NA |
What the registry record for NCT01798407 still lists
NCT01798407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Treatment-Resistant Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Activa Tremor Control Sys (DBS Implant) is the first listed.
NCT01798407 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01798407 about?
NCT01798407 is a clinical study titled "DBS of the Lateral Habenula in Treatment-Resistant Depression". This research study will investigate the safety, tolerability, and benefit of bilateral deep brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD), or bipolar disorder (BD)...
What is the current status of trial NCT01798407?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2013-02. Estimated completion is 2026-08.
What conditions does trial NCT01798407 study?
This clinical trial studies the following conditions: Treatment-Resistant Major Depressive Disorder.
What interventions are being tested in trial NCT01798407?
The interventions under investigation include: Activa Tremor Control Sys (DBS Implant) (DEVICE), Randomized, staggered withdrawal phase (OTHER).
Who is sponsoring clinical trial NCT01798407?
This trial is sponsored by Wayne Goodman MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01798407 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
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Where NCT01798407's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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