Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression
NCT03653858, Not applicable, Completed, University Hospital Freiburg
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression | ClinicalTrials.gov |
| NCT number | NCT03653858 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University Hospital Freiburg | ClinicalTrials.gov |
| Conditions | Treatment-resistant Depression | ClinicalTrials.gov |
| Interventions | Vercise GEVIA deep brain stimulation (DBS) system | ClinicalTrials.gov |
| First posted | 2018-08-31 | ClinicalTrials.gov |
| Last updated | 2026-04-28 | ClinicalTrials.gov |
Registered outcomes 49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale (MADRS) total score | 16 weeks after surgery | Primary outcome (Efficacy). MADRS is an established instrument to rate symptoms of depression. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Each of the 10 items yields a score of 0 to 6. These item scores are summed up to yield a total score. The range of the total score is thus 0 to 60; higher total scores indicate more severe depressive symptoms. Usual cutoff points are: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression | ClinicalTrials.gov |
| Primary | Time to Montgomery-Asberg Depression Rating Scale (MADRS) augmentation of >5 points or clinical worsening in two consecutive visits after DBS termination | Up to 3 months | Primary outcome in 2nd stage; Description MADRS: see above. | ClinicalTrials.gov |
| Primary | Assessment of (Serious) Adverse Events related to Investigational Medical Device and / or surgical procedures | From IMD implantation until the end of study; assessed up to 77 weeks | Primary outcome (Safety); (Serious) adverse events seen will be reported using standard descriptive statistical methods. | ClinicalTrials.gov |
| Secondary | Hamilton Depression Rating Scale (HDRS-28) total score | 16 weeks after surgery | HDRS is an established instrument to rate symptoms of depression. Different versions exist, using between 17 and 29 items. In this study, the 28-item version (HDRS-28) is used. The patient is rated by a clinician, items are scored either on a 3-point or 5-point Likert-type scale. Single item scores are summed up to yield a total score. The total score ranges from 0 to 85; a higher total score indicates more severe depressive symptoms. | ClinicalTrials.gov |
| Secondary | Clinical Global Impression Score (CGI) total score | 16 weeks after surgery | The CGI is a scale that measures the global severity of illness, the global improvement relative to the beginning of the study as well as the therapeutic effect and adverse reactions, score ranges from 0 to 7 for severity of illness and global improvement, a higher score indicates more severe symptoms and a worsening of symptoms; score ranges from 0 to 8 for the efficacy index, 0 means that the efficacy can't be evaluated, a score of 2 means best efficacy while a score of 8 means no therapeutic effect and more adverse reactions | ClinicalTrials.gov |
| Secondary | Global Assessment of Functioning (GAF) total score | 16 weeks after surgery | Score ranges from 100 (high functioning) to 1 (severly impaired) | ClinicalTrials.gov |
| Secondary | Beck Depression Inventory (BDI-II) total score | 16 weeks after surgery | Score ranges from 0 to 63; a higher total score indicates more severe depressive symptoms | ClinicalTrials.gov |
| Secondary | 36-Item Short Form Health Survey (SF-36) total score | 16 weeks after surgery | Health-related quality of life questionnaire; 8 subscales: General health perceptions, physical functioning, role limitations due to physical problems, bodily pain, vitality, general mental health, role limitations due to emotional problems, social functioning. The score in each subscale ranges from 0 to 100; subscores add up to two total scores, "physical health" and "mental health", each with a score range of 0-400. Higher scores indicate better health-related quality of life. | ClinicalTrials.gov |
| Secondary | Change over time in HDRS total score after DBS surgery with DB stimulation OFF compared to stimulation ON | assessed weekly for 16 weeks after surgery | HDRS: see above | ClinicalTrials.gov |
| Secondary | Change over time in CGI total score after DBS surgery with DB stimulation OFF compared to stimulation ON | assessed weekly for 16 weeks after surgery | CGI: see above | ClinicalTrials.gov |
| Secondary | Change over time in GAF total score after DBS surgery with DB stimulation OFF compared to stimulation ON | assessed weekly for 16 weeks after surgery | GAF: see above | ClinicalTrials.gov |
| Secondary | Change over time in BDI-II total score after DBS surgery with DB stimulation OFF compared to stimulation ON | assessed weekly for 16 weeks after surgery | BDI-II: see above | ClinicalTrials.gov |
| Secondary | Change over time in SF-36 total score after DBS surgery with DB stimulation OFF compared to stimulation ON | assessed weekly for 16 weeks after surgery | SF-36: see above | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: Rey Complex Figure Test (CFT) | at 4 months after implantation | Score range 0-36, higher scores indicate better cognitive performance | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: d2 concentration test (d2) | at 4 months after implantation | Higher scores indicate better cognitive performance (total of right answers minus errors) | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: 5-Point-Test | at 4 months after implantation | Score range 0-35, higher scores indicate better cognitive performance | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: Wechsler Adult Intelligence Scale (WAIS) (vocabulary, similarities) | at 4 months after implantation | Score range "vocabulary": 0-32, Score range "finding similarities": 0-32, higher scores indicate better cognitive performance | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: Mini-Mental-Status-Test (MMST) | at 4 months after implantation | Score range 0-30, higher scores indicate better cognitive performance | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: Multiple-Choice Vocabulary Intelligence Test (MWT-B) | at 4 months after implantation | Score range 0-37, higher scores indicate better cognitive performance | ClinicalTrials.gov |
| Secondary | Neuropsychological Assessments: Rey Visual Design Learning Test (RVDLT) | at 4 months after implantation | Score range 0-75, higher scores indicate better cognitive performance | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)