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Posted by Phillipa on November 23, 2011, at 20:12:35
Maybe it won't be new meds for depression? Phillipa
From Medscape Medical News > Psychiatry
More Evidence DBS Effective for Severe Depression. Deborah Browser.
November 22, 2011 One of the first multicenter pilot studies to examine deep-brain stimulation (DBS) for severe depression confirms earlier evidence that this treatment is effective.In the open-label study, investigators targeted the subcallosal cingulate gyrus area of the brain in 21 patients with long-term treatment-resistant depression (TRD). One year after receiving DBS implantation, a majority of the study participants showed a 40% reduction in symptoms of depression.
"The reduction in depression scores is clinically significant as these patients had previously tried multiple medications, psychotherapy, and/or electroconvulsive therapy without success," principal investigator Andres M. Lozano, MD, PhD, neurosurgeon at Toronto Western Hospital and professor of neurosurgery at the University of Toronto, Ontario, Canada, said in a release.
"To see 62% of the patients in this study respond at 1 year gives us hope that this research may lead to a therapy for this hard-to-treat patient population," added Dr. Lozano.
The study was published online November 18 in the Journal of Neurosurgery.
Severely Depressed
In 2005, Dr. Lozano and colleagues published results from a single-site study that showed efficacy of DBS treatment in a majority of 20 patients with TRD. The investigators write that they then sought to replicate these findings across several centers.
For the current study, they enrolled 21 adults with TRD (60% female; mean age, 47.3 years; mean years of depression, 20 years) at 3 sites in Canada.
All participants were unable to work at time of enrollment, and the mean number of medications they had tried previously was 16. For all, the Libra DBS system (St. Jude Medical) was implanted near the collarbone to deliver mild current pulses to the subcallosal cingulate gyrus, which is located within Brodmann area 25.
The Hamilton Rating Scale for Depression (HRSD-17) was used to evaluate symptoms at baseline and at 1-, 6-, and 12-month follow-ups.
The primary outcome measure was at least a 50% reduction in HRSD-17 symptom scores at the 1-year assessment. Secondary measures included scores on the Clinical Global Impression of Severity scale, to evaluate illness severity.
Mixed Results
Results showed that although 57% of the participants had a 50% reduction in HRSD-17 symptom scores at the 1-month follow-up, only 48% showed the reduction at the 6-month mark and only 29% showed it at the 1-year mark.
"The apparent drop in efficacyis potentially worrisome but may be somewhat of an artifact of the data analysis," write the investigators.
A total of 62% of the patients had a 40% or more reduction in symptom scores between baseline and the 1-year follow-up.
Patients also shifted from being severely ill to being less ill after surgery, and the majority improved after the procedure, write the researchers.
Adverse event reports included nausea and vomiting (n = 7), headache (n = 6), superficial skin erosion (n = 1), and lead extension malfunction (n = 1).
In addition, 1 patient committed suicide 8 weeks after device implantation. Another attempted suicide between weeks 4 and 5, but this was thought to be due to a family matter.
According to the release, the investigators are conducting a larger follow-up study at 20 US and international sites.
Garnering Significant Interest
"Dr. Lozano and his clinical collaborators have given us an interesting and important study," writes Kim J. Burchiel, MD, from the Department of Neurological Surgery at Oregon Health and Science University in Portland, in an accompanying editorial.
However, Dr. Burchiel notes that because of its open-label design, the study "cannot be regarded as evidence of efficacy; only safety can be assessed to some degree."
In addition, he calls the 29% 1-year improvement rate "modest," adding that it may be consistent with a placebo response.
"Clearly, a larger prospective randomized trial with longer follow-up will be required to address the issue of long-term efficacy."
Still, Dr. Burchiel writes that the possibility that DBS could someday be proven to be helpful for patients with TRD is garnering significant interest in the fields of both psychiatry and neurological surgery.
"One can envision that this would represent a major milestone in functional neurosurgery and would reinvigorate invasive treatment of behavioral disorders," he writes.
"I believe that we can all agree that if this therapy is to advance and mature, it must be rigorously proven to be both safe and effective. I am confident that Dr. Lozano and colleagues will be at the forefront of this effort."
The study was supported by St. Jude Medical Inc. The study authors disclosed several financial relationships, which are listed in the original article. Dr. Burchiel has disclosed no relevant financial relationships.
J Neurosurg. Published online November 18, 2011
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