Deep Brain Stimulation in Treatment Refractory Depression

Status Terminated

Clinical Trial Summary

The main aim of this trial was to investigate whether patients suffering from treatment refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus of the stria terminalis (CI/BNST)

Clinical Trial Description

This study aims to investigate the effect of deep brain stimulation (DBS)in major depressive disorder (MDD). After implantation of the DBS system, the effects of deep brain stimulation in ITP and CI/BNST will be evaluated.

The design of the study consists of two consecutive crossover phases, interspaced with 2 optimalisation episodes. After a period of optimalisation of CI/BNST stimulation parameters, patients will be randomised in two groups. Half of the group of patients will receive stimulation in CI/BNST. The other half will not. After one week both groups will switch conditions during a period of one week. This will give an idea of the effects of stimulation in CI/BNST on the outcome measures. Outcome measures will be evaluated after each week.

After this first crossover patients will continue to an optimalisation phase of ITP stimulation parameters. A second crossover will then follow. The effects of ITP stimulation, CI/BNST stimulation and no stimulation will be compared. In this phase patients will again be randomised to receive one of the six possible combinations of three consecutive periods of two months for the three different stimulation conditions (ITP stimulation, CI/BNST stimulation and no stimulation).

Evaluations of outcome measures will be performed by blinded evaluators. This design will limit the duration of periods in which these severly ill patients are not stimulated. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01921543
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	January 2005
Completion date	October 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05537558` - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated	`NCT02192099` - Open Label Extension for GLYX13-C-202, NCT01684163	Phase 2
Completed	`NCT03142919` - Lipopolysaccharide (LPS) Challenge in Depression	Phase 2
Recruiting	`NCT05547035` - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders	N/A
Terminated	`NCT02940769` - Neurobiological Effects of Light on MDD	N/A
Recruiting	`NCT05892744` - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression	Phase 4
Recruiting	`NCT05537584` - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment	Phase 4
Active, not recruiting	`NCT05061706` - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder	Phase 3
Completed	`NCT04479852` - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder	Phase 2
Recruiting	`NCT04032301` - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans	Phase 1
Recruiting	`NCT05527951` - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study	N/A
Completed	`NCT03511599` - Cycloserine rTMS Plasticity Augmentation in Depression	Phase 1
Recruiting	`NCT04392947` - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation	N/A
Recruiting	`NCT05895747` - 5-HTP and Creatine for Depression R33 Phase	Phase 2
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Recruiting	`NCT05813093` - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression	N/A
Recruiting	`NCT05135897` - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation	`NCT04509102` - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder	Early Phase 1
Recruiting	`NCT06145594` - EMA-Guided Maintenance TMS for Depression	N/A
Recruiting	`NCT06026917` - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Deep Brain Stimulation in Treatment Refractory Depression — DBSTRD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms