scholarly journals Relationship between Clozapine-Induced Electroencephalogram Abnormalities and Serum Concentration of Clozapine in Japanese Patients with Treatment-Resistant Schizophrenia

2019 ◽  
Vol 16 (4) ◽  
pp. 279-284 ◽  
Author(s):  
Yuka Sugawara Kikuchi ◽  
Takashi Kanbayashi ◽  
Tetsuo Shimizu
Keyword(s):  
Serum Concentration ◽  
Japanese Patients ◽  
Treatment Resistant

scholarly journals Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nagahide Takahashi ◽  
Aya Yamada ◽  
Ayako Shiraishi ◽  
Hiroko Shimizu ◽  
Ryosuke Goto ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Japanese Patients ◽  
Controlled Study ◽  
Induction Phase ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Madrs Total Score ◽  
Link Type ◽  
Randomized Clinical Study ◽  
Resistant Depression

Abstract Background Esketamine nasal spray (Spravato) in conjunction with oral antidepressants (ADs) is approved in the European Union, United States, and other markets for treatment-resistant depression (TRD). Efficacy, safety, and tolerability of esketamine nasal spray in Japanese patients with TRD needs to be assessed. Methods This Phase 2b, randomized, double-blind (DB), placebo-controlled study was conducted in adult Japanese patients with TRD meeting the Diagnostic and Statistical Manual of Mental Disorders (fifth edition) criteria of major depressive disorder with nonresponse to ≥ 1 but < 5 different ADs in the current episode at screening. Patients were treated with a new oral AD for 6 weeks (prospective lead-in phase); nonresponders were randomized (2:1:1:1) to placebo or esketamine (28-, 56-, or 84-mg) nasal spray along with the continued use of AD for 4 weeks (DB induction phase). Responders (≥50% reduction from baseline in the Montgomery-Asberg Depression Rating Scale [MADRS] total score) from the DB induction phase continued into the 24-week posttreatment phase and patients who relapsed could participate in a 4-week open-label (OL) second induction (flexibly-dosed esketamine). The primary efficacy endpoint, change from baseline in the MADRS total score at Day 28 in the DB induction phase, was based on mixed-effects model using repeated measures pairwise comparisons using a Dunnett adjustment. Results Of the 202 patients randomized in the DB induction phase (esketamine [n = 122] or placebo [n = 80]), the MADRS total scores decreased from baseline to Day 28 of the DB induction phase (− 15.2, − 14.5, − 15.1, and − 15.3 for esketamine 28 mg, 56 mg, 84 mg, and placebo groups, respectively), indicating an improvement in depressive symptoms; however, the difference between the esketamine and placebo groups was not statistically significant. The most common treatment-emergent adverse events during the DB induction phase in the combined esketamine group (incidences ranging from 12.3 to 41.0%) were blood pressure increased, dissociation, dizziness, somnolence, nausea, hypoaesthesia, vertigo, and headache; the incidence of each of these events was > 2-fold higher than the corresponding incidence in the placebo group. Conclusions Efficacy of esketamine plus oral AD in Japanese TRD patients was not established; further investigation is warranted. All esketamine doses were safe and tolerated. Trial registration ClinicalTrials.gov Identifier: NCT02918318. Registered: 28 September 2016.

Efficacy and tolerability of high dose olanzapine in Japanese patients with treatment-resistant schizophrenia

2013 ◽  
Vol 6 (1) ◽  
pp. 86-87 ◽  
Author(s):  
Taro Kishi ◽  
Tatsuyo Suzuki ◽  
Hirotaka Sekiguchi ◽  
Masatsugu Moriwaki ◽  
Akiko Okuda ◽  
...  
Keyword(s):  
Japanese Patients ◽  
High Dose ◽  
Treatment Resistant

Association study between Disrupted-in-Schizophrenia-1 (DISC1) and Japanese patients with treatment-resistant schizophrenia (TRS)

2011 ◽  
Vol 35 (2) ◽  
pp. 636-639 ◽  
Author(s):  
Yuri Hotta ◽  
Tohru Ohnuma ◽  
Ryo Hanzawa ◽  
Nobuto Shibata ◽  
Hitoshi Maeshima ◽  
...  
Keyword(s):  
Association Study ◽  
Japanese Patients ◽  
Treatment Resistant

Risk factors for clozapine-induced central nervous system abnormalities in Japanese patients with treatment-resistant schizophrenia

2021 ◽  
pp. 102652
Author(s):  
Kohei Kitagawa ◽  
Shusuke Uekusa ◽  
Kazuhiro Matsuo ◽  
Kei Moriyama ◽  
Tatsuro Yamamoto ◽  
...  
Keyword(s):  
Risk Factors ◽  
Central Nervous System ◽  
Nervous System ◽  
Japanese Patients ◽  
Treatment Resistant

scholarly journals Serum cystatin C levels to predict serum concentration of digoxin in Japanese patients

2006 ◽  
pp. 92-96 ◽  
Author(s):  
Tsutomu Nakamura ◽  
Takeshi Ioroi ◽  
Toshiyuki Sakaeda ◽  
Masanori Horinouchi ◽  
Nobuhide Hayashi ◽  
...  
Keyword(s):  
Serum Concentration ◽  
Cystatin C ◽  
Japanese Patients ◽  
Serum Cystatin C ◽  
Serum Cystatin

scholarly journals Copper Concentrations in Ketamine Therapy for Treatment-Resistant Depression

2020 ◽  
Vol 10 (12) ◽  
pp. 971
Author(s):  
Jakub Słupski ◽  
Wiesław Jerzy Cubała ◽  
Natalia Górska ◽  
Anita Słupska ◽  
Maria Gałuszko-Węgielnik
Keyword(s):  
Serum Concentration ◽  
Treatment Response ◽  
Copper Concentration ◽  
Rating Scale ◽  
Serum Copper ◽  
Copper Level ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Somatic Comorbidities ◽  
Resistant Depression

Changes in serum copper concentration are observed in patients with depressive symptoms. Unmet needs in contemporary antidepressant treatment have increased interest in non-monoaminergic antidepressants, such as ketamine, an anaesthetic drug that has demonstrated a rapid antidepressant effect in patients with treatment-resistant depression (TRD). The purpose of this study was to examine whether serum copper concentrations change during ketamine treatment and whether there is an association between the copper concentrations and treatment response measured using psychometric scale scores. Moreover, the interlink between somatic comorbidities and copper concentration was studied. Patients with major depressive disorder or bipolar disorder were rated weekly by a clinician using the Montgomery–Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Copper level assessments were carried out weekly before the start of ketamine treatment and then after every second infusion and one week after the last ketamine infusion. The serum concentration of copper before ketamine treatment was significantly higher than that after the fifth infusion (p = 0.016), and the serum concentration after the treatment was significantly higher than that after the fifth infusion (p = 0.048). No significant correlations between changes in the copper serum concentrations and MADRS or YMRS were found. The serum copper level was not associated with somatic comorbidities during the course of treatment. This study provides data on the role of copper in short-term intravenous ketamine treatment in TRD, although no clear evidence of a connection between the copper level and treatment response was found.

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