A single-site, double-blind, placebo-controlled, dose-ranging study of YKP10A--a putative, new antidepressant. Export

@article{citeulike:5308812, abstract = {BACKGROUND: YKP10A is a novel, new antidepressant that may affect dopamine neurotransmission. We present results from the first Phase II clinical trial of YKP10A antidepressant activity in patients with major depression. METHODS: This was a single-site, placebo-controlled, dose-ranging study. Patients with major depression were randomly assigned to one of four double-blind treatment conditions: YKP10A 100-300 mg/day, YKP10A 400-600 mg/day, YKP10A 700-900 mg/day, or placebo for 8 weeks. RESULTS: 43 patients were screened and 35 were randomized. Nineteen patients (54.3\%) completed the entire 8-week study. Five YKP10A-treated patients (19\%) discontinued treatment for adverse events. Thirty-eight percent of patients in the medium dose YKP10A group had a reduction in baseline HAM-D17 score > or = 50\% compared with the low-dose (13\%), high-dose (13\%), and placebo (29\%) groups. A similar nonsignificant 'signal' for therapeutic activity was also seen in the medium-dose YKP10A group on the HAM-D28 and the Montgomery-Asberg Depression Rating Scale (MADRS). Headaches, nervousness, agitation, insomnia, and gastrointestinal complaints were the most commonly reported side effects. Two cases of hypomania were observed. LIMITATIONS: This preliminary, single-site study was not powered to detect a statistically significant difference from placebo among treatment groups. CONCLUSION: YKP10A may have antidepressant activity at a daily dose range of 400-600 mg.}, author = {Amsterdam, Jay D. and Brunswick, David J. and Hundert, Miriam}, citeulike-article-id = {5308812}, citeulike-linkout-0 = {http://view.ncbi.nlm.nih.gov/pubmed/12502022}, citeulike-linkout-1 = {http://www.hubmed.org/display.cgi?uids=12502022}, issn = {0278-5846}, journal = {Progress in neuro-psychopharmacology \& biological psychiatry}, keywords = {antidepressant, da, depression, dopamine, ham-d17, ham-d28, madrs, montgomery-asberg, ykp10a}, month = {December}, number = {7-8}, pages = {1333--1338}, posted-at = {2009-07-31 14:46:44}, priority = {2}, title = {A single-site, double-blind, placebo-controlled, dose-ranging study of YKP10A--a putative, new antidepressant.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/12502022}, volume = {26}, year = {2002} }

TY - JOUR ID - citeulike:5308812 L3 - citeulike-article-id:5308812 N2 - BACKGROUND: YKP10A is a novel, new antidepressant that may affect dopamine neurotransmission. We present results from the first Phase II clinical trial of YKP10A antidepressant activity in patients with major depression. METHODS: This was a single-site, placebo-controlled, dose-ranging study. Patients with major depression were randomly assigned to one of four double-blind treatment conditions: YKP10A 100-300 mg/day, YKP10A 400-600 mg/day, YKP10A 700-900 mg/day, or placebo for 8 weeks. RESULTS: 43 patients were screened and 35 were randomized. Nineteen patients (54.3%) completed the entire 8-week study. Five YKP10A-treated patients (19%) discontinued treatment for adverse events. Thirty-eight percent of patients in the medium dose YKP10A group had a reduction in baseline HAM-D17 score > or = 50% compared with the low-dose (13%), high-dose (13%), and placebo (29%) groups. A similar nonsignificant 'signal' for therapeutic activity was also seen in the medium-dose YKP10A group on the HAM-D28 and the Montgomery-Asberg Depression Rating Scale (MADRS). Headaches, nervousness, agitation, insomnia, and gastrointestinal complaints were the most commonly reported side effects. Two cases of hypomania were observed. LIMITATIONS: This preliminary, single-site study was not powered to detect a statistically significant difference from placebo among treatment groups. CONCLUSION: YKP10A may have antidepressant activity at a daily dose range of 400-600 mg. IS - 7-8 JF - Progress in neuro-psychopharmacology & biological psychiatry SN - 0278-5846 EP - 1338 TI - A single-site, double-blind, placebo-controlled, dose-ranging study of YKP10A--a putative, new antidepressant. VL - 26 SP - 1333 KW - antidepressant KW - da KW - depression KW - dopamine KW - ham-d17 KW - ham-d28 KW - madrs KW - montgomery-asberg KW - ykp10a AU - Amsterdam, Jay AU - Brunswick, David AU - Hundert, Miriam PY - 2002/12// UR - http://view.ncbi.nlm.nih.gov/pubmed/12502022 ER -