Trial · NCT01372722
Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder
NCT01372722, Phase 2, Phase 3, Withdrawn, University Hospital, Bonn
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder. Trials, record NCT01372722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01372722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder
- NCT number
- NCT01372722
- Status
- Withdrawn
- Phases
- Phase 2, Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- University Hospital, Bonn
- Conditions
- Bipolar Disorder
- Interventions
- DBS Activa PC systems Medtronic, DBS, Activa PC systems Medtronic
- First posted
- 2011-06-14
- Last updated
- 2018-08-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Depression Severity rated with Montgomery Asberg Depression Scale (MADRS) | 12 month after DBS stimulation onset | The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale is. |
| Primary | Young Mania Rating Scale (YMRS) | 12 month after DBS stimulation onset | One of the most frequently used rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. This scale will be used to assess the development of manic symptoms over time, mainly in order to assess treatment emergent manic symptoms. |
| Secondary | Depression Severity rated with Hamilton Depression Rating Scale (HDRS24) | 12 month after DBS stimulation onset | The Hamilton Rating Scale for Depression (HRSD), also known as the Hamilton Depression Rating Scale (HDRS) or abbreviated to HAM-D, is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research. |
| Secondary | Adverse Event Schedule | 12 month after DBS stimulation onset | Adverse events induced by the Stimulation will be recorded during the study using a structured questionnaire. 12 months after stimulation onset results will be compiled and rated as being due to DBS or not. |
| Secondary | Comprehensive neuropsychological test battery | 12 month after DBS stimulation onset | * General cognitive functions (Mini-Mental State Examination) * Attention (d2 attention-burden test) * Learning and memory tests covering verbal and visual spatial learning, memory and working memory (Verbal Learning and Memory Test, Rey Visual Design Learning Test,Wechsler Memory Scale) * language (HAWIE lexis tests, HAWIE finding similarities) * Executive functions (Trail Making Tests, Five-Point Test, and the Stroop test) * Visual perception (Hooper Visual Organization Test) |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Tests3
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | 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/NCT01372722
GET https://conductscience.org/api/trials/v1/NCT01372722/registered