Deep Brain Stimulation for Treatment Resistant Depression (NCT00367003) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Deep Brain Stimulation for Treatment Resistant Depression
United States37 participantsStarted 2006-09
Plain-language summary
The purpose of this study is to test the safety, efficacy and mechanism of action of subgenual cingulate (Cg25) deep brain stimulation (DBS) for major depression in patients who have not responded to prior antidepressant treatments. Participation in the study will continue for ten years or until the device receives FDA approval for depression. Forty (40) patients will be enrolled in this study.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria:
* Ability to provide written informed consent.
* Current Major Depressive Episode (MDE), secondary to either Major Depressive Disorder or Bipolar Disorder (I, II or NOS), diagnosed by structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-IV-text revision (DSM-IV-TR).
* Current MDE at least two years duration OR a history of more than 4 lifetime depressive episodes.
* Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17).
* Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score.
* A maximum Global Assessment of Functioning of 50.
* Treatment-resistant depression defined as:
* Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode.
* Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode (confirmed by medical records), or refusal of ECT due to a reason considered to be valid by the study psychiatrist.
* A patient may remain on psychotropic medications during this study. However, doses must remain stable during the …
What they're measuring
1
Change in Hamilton Depression Rating Scale-17 Score