A Phase 1/2 interventional study of ITP Stimulation and CI/BNST stimulation in Major Depressive Disorder, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-16.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 1/2, Interventional, and Treatment
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)
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Failure to respond to:
Exclusion Criteria:
Device: CI/BNST stimulation
randomized, double blind, 1 week crossover
Device: CI/BNST stimulation · Device: No stimulation
Device: ITP Stimulation
randomized, double blind, two month crossover
Device: ITP Stimulation · Device: CI/BNST stimulation · Device: No stimulation
Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision
Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision
Change from baseline in depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale
The time frame is an approximation as evaluation is performed after each crossover phase. The time interval between baseline and evaluation depends on the time required for optimisation of DBS parameters.
Time frame: up to 14 months
Montgomery- Asberg Depression Rating Scale (MADRS)
Time frame: up to 14 months
Inventory for Depressive Symptoms, Self-Report (IDS-SR)
Time frame: up to 14 months
Global measures of illness severity and improvement:the clinician-rated Clinical Global Impressions - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I) scales, and the patient-rated Patient Global Impressions (PGI-S and PGI-I)
Time frame: up to 14 months
Global Assessment of Function (GAF)
Time frame: up to 14 months
patient-rated Symptom CheckList (SCL-90)
Time frame: up to 14 months
Cognitive function: Rey Auditory Verbal Learning Test; Trailmaking A & B, Stroop Test, Rey-Osterrieth complex figure test ; Wisconsin Card Sorting Test; Standard Progressive Matrices of Raven; Digit Span Test; Word Fluency Test
Time frame: up to 14 months
Hopelessness: using the Beck Hopelessness scale
Time frame: up to 14 months
Hamilton Anxiety Rating Scale (HARS)
Time frame: up to 14 months
Young Mania Rating Scale (YMRS)
Time frame: up to 14 months
Side Effects Questionnaire (SEQ)
Time frame: up to 14 months
This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven