PMID- 19005196 OWN - NLM STAT- MEDLINE DCOM- 20081124 LR - 20220419 IS - 1533-4406 (Electronic) IS - 0028-4793 (Linking) VI - 359 IP - 20 DP - 2008 Nov 13 TI - Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. PG - 2121-34 LID - 10.1056/NEJMoa0708514 [doi] AB - BACKGROUND: Severe, refractory obsessive-compulsive disorder (OCD) is a disabling condition. Stimulation of the subthalamic nucleus, a procedure that is already validated for the treatment of movement disorders, has been proposed as a therapeutic option. METHODS: In this 10-month, crossover, double-blind, multicenter study assessing the efficacy and safety of stimulation of the subthalamic nucleus, we randomly assigned eight patients with highly refractory OCD to undergo active stimulation of the subthalamic nucleus followed by sham stimulation and eight to undergo sham stimulation followed by active stimulation. The primary outcome measure was the severity of OCD, as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), at the end of two 3-month periods. General psychopathologic findings, functioning, and tolerance were assessed with the use of standardized psychiatric scales, the Global Assessment of Functioning (GAF) scale, and neuropsychological tests. RESULTS: After active stimulation of the subthalamic nucleus, the Y-BOCS score (on a scale from 0 to 40, with lower scores indicating less severe symptoms) was significantly lower than the score after sham stimulation (mean [+/-SD], 19+/-8 vs. 28+/-7; P=0.01), and the GAF score (on a scale from 1 to 90, with higher scores indicating higher levels of functioning) was significantly higher (56+/-14 vs. 43+/-8, P=0.005). The ratings of neuropsychological measures, depression, and anxiety were not modified by stimulation. There were 15 serious adverse events overall, including 1 intracerebral hemorrhage and 2 infections; there were also 23 nonserious adverse events. CONCLUSIONS: These preliminary findings suggest that stimulation of the subthalamic nucleus may reduce the symptoms of severe forms of OCD but is associated with a substantial risk of serious adverse events. (ClinicalTrials.gov number, NCT00169377.) CI - 2008 Massachusetts Medical Society FAU - Mallet, Luc AU - Mallet L AD - The authors' affiliations are listed in the Appendix. FAU - Polosan, Mircea AU - Polosan M FAU - Jaafari, Nematollah AU - Jaafari N FAU - Baup, Nicolas AU - Baup N FAU - Welter, Marie-Laure AU - Welter ML FAU - Fontaine, Denys AU - Fontaine D FAU - du Montcel, Sophie Tezenas AU - du Montcel ST FAU - Yelnik, Jerome AU - Yelnik J FAU - Chereau, Isabelle AU - Chereau I FAU - Arbus, Christophe AU - Arbus C FAU - Raoul, Sylvie AU - Raoul S FAU - Aouizerate, Bruno AU - Aouizerate B FAU - Damier, Philippe AU - Damier P FAU - Chabardes, Stephan AU - Chabardes S FAU - Czernecki, Virginie AU - Czernecki V FAU - Ardouin, Claire AU - Ardouin C FAU - Krebs, Marie-Odile AU - Krebs MO FAU - Bardinet, Eric AU - Bardinet E FAU - Chaynes, Patrick AU - Chaynes P FAU - Burbaud, Pierre AU - Burbaud P FAU - Cornu, Philippe AU - Cornu P FAU - Derost, Philippe AU - Derost P FAU - Bougerol, Thierry AU - Bougerol T FAU - Bataille, Benoit AU - Bataille B FAU - Mattei, Vianney AU - Mattei V FAU - Dormont, Didier AU - Dormont D FAU - Devaux, Bertrand AU - Devaux B FAU - Verin, Marc AU - Verin M FAU - Houeto, Jean-Luc AU - Houeto JL FAU - Pollak, Pierre AU - Pollak P FAU - Benabid, Alim-Louis AU - Benabid AL FAU - Agid, Yves AU - Agid Y FAU - Krack, Paul AU - Krack P FAU - Millet, Bruno AU - Millet B FAU - Pelissolo, Antoine AU - Pelissolo A CN - STOC Study Group LA - eng SI - ClinicalTrials.gov/NCT00169377 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 SB - IM EIN - N Engl J Med. 2009 Sep 3;361(10):1027 CIN - N Engl J Med. 2009 Feb 26;360(9):931; author reply 932. PMID: 19246368 CIN - N Engl J Med. 2009 Feb 26;360(9):931-2; author reply 932. PMID: 19256029 MH - Adult MH - Cerebral Hemorrhage/etiology MH - Cross-Over Studies MH - Double-Blind Method MH - *Electric Stimulation Therapy/adverse effects MH - Female MH - Humans MH - Infections/etiology MH - Male MH - Middle Aged MH - Obsessive-Compulsive Disorder/*therapy MH - *Subthalamic Nucleus FIR - Mallet, L IR - Mallet L FIR - Agid, Y IR - Agid Y FIR - Aouizerate, B IR - Aouizerate B FIR - Arbus, C IR - Arbus C FIR - Bougerol, T IR - Bougerol T FIR - Damier, P IR - Damier P FIR - Fontaine, D IR - Fontaine D FIR - Houeto, J L IR - Houeto JL FIR - Krebs, M O IR - Krebs MO FIR - Lemaire, J J IR - Lemaire JJ FIR - Mallet, L IR - Mallet L FIR - Millet, B IR - Millet B FIR - Pollak, P IR - Pollak P FIR - Hourton, D IR - Hourton D FIR - Aprelon, S IR - Aprelon S FIR - Jourdain, C IR - Jourdain C FIR - Bardinet, E IR - Bardinet E FIR - Yelnik, J IR - Yelnik J FIR - Burbaud, P IR - Burbaud P FIR - Welter, M L IR - Welter ML FIR - Clair, A H IR - Clair AH FIR - Czernecki, V IR - Czernecki V FIR - Verin, M IR - Verin M FIR - du Montcel, S Tezenas IR - du Montcel ST FIR - Madar, D IR - Madar D FIR - Mallet, L IR - Mallet L FIR - Pelissolo, A IR - Pelissolo A FIR - Agid, Y IR - Agid Y FIR - Cornu, P IR - Cornu P FIR - Navarro, S IR - Navarro S FIR - Welter, M L IR - Welter ML FIR - Hartmann, A IR - Hartmann A FIR - Pidoux, B IR - Pidoux B FIR - Grabli, D IR - Grabli D FIR - Czernecki, V IR - Czernecki V FIR - Dormont, D IR - Dormont D FIR - Galanaud, D IR - Galanaud D FIR - Yelnik, J IR - Yelnik J FIR - Bardinet, E IR - Bardinet E FIR - Behar, C IR - Behar C FIR - Worbe, Y IR - Worbe Y FIR - Clair, A H IR - Clair AH FIR - Moutaud, B IR - Moutaud B FIR - Aouizerate, B IR - Aouizerate B FIR - Burbaud, P IR - Burbaud P FIR - Cuny, E IR - Cuny E FIR - Guehl, D IR - Guehl D FIR - Llorca, P M IR - Llorca PM FIR - Chereau, I IR - Chereau I FIR - Lemaire, J J IR - Lemaire JJ FIR - Durif, F IR - Durif F FIR - Derost, P IR - Derost P FIR - Coste, J IR - Coste J FIR - Gabrillargues, J IR - Gabrillargues J FIR - Barget, M IR - Barget M FIR - de Chazeron, I IR - de Chazeron I FIR - Bougerol, T IR - Bougerol T FIR - Polosan, M IR - Polosan M FIR - Benabid, A L IR - Benabid AL FIR - Chabardes, S IR - Chabardes S FIR - Seigneuret, E IR - Seigneuret E FIR - Krack, P IR - Krack P FIR - Pollak, P IR - Pollak P FIR - Ardouin, C IR - Ardouin C FIR - Le Bas, J F IR - Le Bas JF FIR - Damier, P IR - Damier P FIR - Lajat, Y IR - Lajat Y FIR - Raoul, S IR - Raoul S FIR - Mattei, V IR - Mattei V FIR - Fontaine, D IR - Fontaine D FIR - Borg, M IR - Borg M FIR - Paquis, P IR - Paquis P FIR - Magnie-Mauro, M N IR - Magnie-Mauro MN FIR - Robert, P IR - Robert P FIR - Michel, E IR - Michel E FIR - Papetti, F IR - Papetti F FIR - Baup, N IR - Baup N FIR - Devaux, B IR - Devaux B FIR - Krebs, M O IR - Krebs MO FIR - Oppenheimer, C IR - Oppenheimer C FIR - Olie, J P IR - Olie JP FIR - Ranoux, D IR - Ranoux D FIR - Chayet, M IR - Chayet M FIR - Houeto, J L IR - Houeto JL FIR - Jaafari, N IR - Jaafari N FIR - Bataille, B IR - Bataille B FIR - Mesnage, V IR - Mesnage V FIR - Gil, R IR - Gil R FIR - Audouin, V IR - Audouin V FIR - Senon, J L IR - Senon JL FIR - Millet, B IR - Millet B FIR - Verin, M IR - Verin M FIR - Drapier, D IR - Drapier D FIR - Sauleau, P IR - Sauleau P FIR - Drapier, S IR - Drapier S FIR - Arbus, C IR - Arbus C FIR - Lazorthe, Y IR - Lazorthe Y FIR - Chaynes, P IR - Chaynes P FIR - Fabre, N IR - Fabre N FIR - Simonetta, M IR - Simonetta M FIR - Schmitt, L IR - Schmitt L FIR - Lotterie, J A IR - Lotterie JA FIR - Camassel, C IR - Camassel C FIR - Best, N IR - Best N FIR - Aussilloux, J C IR - Aussilloux JC FIR - Blond, S IR - Blond S FIR - Feingold, J IR - Feingold J FIR - Sicard, D IR - Sicard D FIR - Ades, J IR - Ades J FIR - Cottraux, J IR - Cottraux J FIR - Goudemand, M IR - Goudemand M EDAT- 2008/11/14 09:00 MHDA- 2008/12/17 09:00 CRDT- 2008/11/14 09:00 PHST- 2008/11/14 09:00 [pubmed] PHST- 2008/12/17 09:00 [medline] PHST- 2008/11/14 09:00 [entrez] AID - 359/20/2121 [pii] AID - 10.1056/NEJMoa0708514 [doi] PST - ppublish SO - N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.