Trial · NCT01798407
DBS of the Lateral Habenula in Treatment-Resistant Depression
NCT01798407, Not applicable, Active not recruiting, Wayne Goodman MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DBS of the Lateral Habenula in Treatment-Resistant Depression. Trials, record NCT01798407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01798407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DBS of the Lateral Habenula in Treatment-Resistant Depression
- NCT number
- NCT01798407
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 6 participants, actual
- Lead sponsor
- Wayne Goodman MD
- Conditions
- Treatment Resistant Major Depressive Disorder
- Interventions
- Activa Tremor Control Sys (DBS Implant), Randomized, staggered withdrawal phase
- First posted
- 2013-02-25
- Last updated
- 2025-11-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HDRS^17 score from baseline to 6 months after the commencement of stimulation | baseline, Month 6, Month 12 and 18 months | 'Response' is categorically defined as a ≥ 50% reduction in the HDRS17 score relative to the baseline assessment. 'Remission' is defined as an absolute HDRS17 score \< 8. Study success criteria will be defined as ≥ 3 of the 6 patients meeting the individual subject success criteria of response or remission by HDRS17 score at the 6 month time point. |
| Secondary | MADRS (Montgomery and Asberg Depression Rating Scale) | baseline, Month 6, Month 12 and 18 months | Clinician administered evaluation of depressive symptoms |
| Secondary | Clinical Global Impression of Severity (CGI-S) | baseline, Month 6, Month 12 and 18 months | Clinician Administered assessment |
| Secondary | Clinical Global Impression of Improvement (CGI-I) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Young Mania Rating Scale (YMRS) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Neuropsychological Battery | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment includes WAIS-IV subscales subscales: Digit Span, Information, Coding, Similarities, and Visual Puzzles; TMT (Trail Making Tests) A and B; Neuropsychological Assessment Battery (NAB): Naming Test; JLO, (Benton Judgment of Line Orientation Test \[Forms H and V\]); HVLT-R (Hopkins Verbal Learning Test-R \[Forms 1, 2, 3, and 4\]); BVMT-R (Brief Visual Spatial Memory Test, Revised \[Forms 1, 2, 3, and 4\]); GPT (Grooved Pegboard Test); COWAT (Controlled Oral Word Association Test) with semantic fluency; WCST (Wisconsin Card Sorting Test) - short version (64 item); Stroop (Stroop Color Word Test); IGT(Iowa Gambling Task) |
| Secondary | QIDS-SR (Quick Inventory of Depressive Symptomatology) | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
| Secondary | Generalized Anxiety Disorder 7-item Scale (GAD-7) | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
| Secondary | Sheehan Disability Scale | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers29
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests10
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 |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Line Angle Matching | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01798407
GET https://conductscience.org/api/trials/v1/NCT01798407/papers?page=2