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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 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. The trial reports 1 study location across 1 state.

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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.

Interventions

  • DEVICE Activa Tremor Control Sys (DBS Implant)
  • OTHER Randomized, staggered withdrawal phase

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2013-02
Est. Completion 2026-08
Phase NA

Sponsor

Wayne Goodman MD

3 total trials

What the Registry Record Tells You About NCT01798407

The ClinicalTrials.gov registry entry for NCT01798407 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne Goodman MD, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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