Deep Brain Stimulation for Treatment-Refractory Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

NCT02046330

Major Depressive Disorder Treatment Resistant Depression

RECRUITING NA

Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression

NCT01778790

Major Depression

COMPLETED PHASE2

Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S

NCT01984710

Treatment Resistant Depression

ACTIVE_NOT_RECRUITING NA

Deep Brain Stimulation for Refractory Major Depression

NCT00296920

Major Depressive Disorder

COMPLETED PHASE3

Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder

NCT01569711

Major Depressive Disorder, Recurrent, Unspecified

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major depression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DBS

Group Type EXPERIMENTAL

Deep Brain Stimulation with Medtronic Activa Neurostimulator

Intervention Type DEVICE

Deep brain stimulation (DBS) at 130 Hz

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deep Brain Stimulation with Medtronic Activa Neurostimulator

Deep brain stimulation (DBS) at 130 Hz

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Activa Neurostimulator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major depression (MD), severe, unipolar type
* German mother tongue
* Hamilton Depression Rating Scale (HDRS24) score of \> 20
* Global Assessment of Function (GAF) score of \< 45
* At least 4 episodes of MD or chronic episode \> 2 years
* \> 5 years after first episode of MD
* Failure to respond to \*adequate trials (\>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;

* adequate trials (\>3 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); \*an adequate trial of electroconvulsive therapy \[ECT\] (\>6 bilateral treatments) and; \*an adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
* Able to give written informed consent
* No medical comorbidity
* Drug free or on stable drug regimen at least 6 weeks before study entry

Exclusion Criteria

* Current or past nonaffective psychotic disorder
* Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
* Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
* Any surgical contraindications to undergoing DBS
* Current or unstably remitted substance abuse (aside from nicotine)
* Pregnancy and women of childbearing age not using effective contraception
* History of severe personality disorder

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No