NCT01095263 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Coenen VA, Mädler B, Schlaepfer TE
Reply to: medial forebrain bundle stimulation-speed access to an old or entry into a new depression neurocircuit? Biol Psychiatry. 2013 Dec 15;74(12):e45-6. doi: 10.1016/j.biopsych.2013.06.017. Epub 2013 Aug 2.
Coenen VA, Schlaepfer TE, Allert N, Mädler B
Diffusion tensor imaging and neuromodulation: DTI as key technology for deep brain stimulation. Int Rev Neurobiol. 2012;107:207-34. doi: 10.1016/B978-0-12-404706-8.00011-5. Review.
Coenen VA, Schlaepfer TE, Maedler B, Panksepp J
Cross-species affective functions of the medial forebrain bundle-implications for the treatment of affective pain and depression in humans. Neurosci Biobehav Rev. 2011 Oct;35(9):1971-81. doi: 10.1016/j.neubiorev.2010.12.009. Epub 2010 Dec 22. Review.
Schlaepfer TE, Bewernick BH, Kayser S, Mädler B, Coenen VA
Rapid effects of deep brain stimulation for treatment-resistant major depression. Biol Psychiatry. 2013 Jun 15;73(12):1204-12. doi: 10.1016/j.biopsych.2013.01.034. Epub 2013 Apr 3. Review.

Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE: FOREbrain Stimulation dEprEssion)

Details for clinical trial NCT01095263

Clinical trial NCT01095263 - References