Add-on mirtazapine improves depressive symptoms in schizophrenia: a double-blind randomized placebo-controlled study with an open-label extension phase

2011 ◽  
pp. n/a-n/a ◽  
Author(s):  
Viacheslav Terevnikov ◽  
Jan-Henry Stenberg ◽  
Jari Tiihonen ◽  
Marina Joffe ◽  
Mark Burkin ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Extension Phase ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension

scholarly journals Safety and effectiveness of ulotaront (SEP-363856) in schizophrenia: results of a 6-month, open-label extension study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Christoph U. Correll ◽  
Kenneth S. Koblan ◽  
Seth C. Hopkins ◽  
Yan Li ◽  
Heather Dworak ◽  
...  
Keyword(s):  
Effect Size ◽  
Metabolic Effects ◽  
Extension Phase ◽  
Extension Study ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Open Label Extension

AbstractUlotaront, a trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors agonist, has demonstrated efficacy in the treatment of patients with an acute exacerbation of schizophrenia in a 4-week, double-blind, placebo-controlled study. The aim of this 26-week open-label extension study was to evaluate the safety and effectiveness of ulotaront (25/50/75 mg/d) in patients who completed the initial 4-week study. Of the 193 4-week completers, 157 patients (81.3%) continued into the open-label extension study; 66.9% were completers. Among all extension phase patients, treatment with ulotaront was associated with minimal changes in body weight (mean [SD] change from double-blind baseline: −0.3 [3.7] kg), cholesterol (median change, −2.0 mg/dL), triglycerides (median, −5.0 mg/dL), and prolactin (female, median, −3.4 ng/mL; male, median, −2.7 ng/mL). Movement disorder scales showed no extrapyramidal effects. Twenty-six weeks of extension phase treatment was associated with a mean (95% CI) observed change from open-label baseline in the PANSS total score of −22.6 (−25.6, −19.6; effect size, 1.46), and a mean (95% CI) change in the CGI-Severity score of −1.0 (−1.2, −0.8; effect size, 1.07). Long-term treatment with the TAAR1 agonist ulotaront, in the daily dose range of 25–75 mg, was characterized by a relatively high completion rate, an adverse event profile notable for the absence of extrapyramidal-related adverse effects, a low liability for adverse weight and metabolic effects, and no effect on prolactin levels. Additional studies are needed to further confirm the long-term efficacy and safety of ulotaront.

EFFECTS OF ADD-ON MIRTAZAPINE ON NEUROCOGNITION IN SCHIZOPHRENIA: AN OPEN LABEL EXTENSION PHASE OF A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY, AND BOTH PHASES

2010 ◽  
Vol 117 (2-3) ◽  
pp. 377 ◽  
Author(s):  
Jan H. Stenberg ◽  
Viacheslav Terevnikov ◽  
Marina Joffe ◽  
Jari Tiihonen ◽  
Evgueni Tchoukhine ◽  
...  
Keyword(s):  
Extension Phase ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension

scholarly journals Design of the Tocilizumab in Giant Cell Arteritis Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Sebastian H. Unizony ◽  
Bhaskar Dasgupta ◽  
Elena Fisheleva ◽  
Lucy Rowell ◽  
Georg Schett ◽  
...  
Keyword(s):  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Treatment Phase ◽  
Controlled Study ◽  
Sustained Remission ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension ◽  
Group A ◽  
Group B

Overview. The GiACTA trial is a multicenter, randomized, double-blind, and placebo-controlled study designed to test the ability of tocilizumab (TCZ), an interleukin (IL)-6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis (GCA).Design. Approximately 100 centers will enroll 250 patients with active disease. The trial consists of a 52-week blinded treatment phase followed by 104 weeks of open-label extension. Patients will be randomized into one of four groups. Group A (TCZ 162 mg weekly plus a 6-month prednisone-taper); group B (TCZ 162 mg every other week plus a 6-month prednisone-taper); group C (placebo plus a 6-month prednisone-taper); and group D (placebo plus a 12-month prednisone taper). We hypothesize that patients assigned to TCZ in addition to a 6-month prednisone course are more likely to achieve the primary efficacy endpoint of sustained remission (SR) at 52 weeks compared with those assigned to a 6-month prednisone course alone, thus potentially minimizing the long-term adverse effects of corticosteroids.Conclusion. GiACTA will test the hypothesis that interference with IL-6 signaling exerts a beneficial effect on patients with GCA. The objective of this paper is to describe the design of the trial and address major issues related to its development.

Sign in / Sign up

Export Citation Format

Share Document