M100907 is an orally active, potent, and highly selective 5-HT2A antagonist with biochemical and pharmacological properties that may provide therapeutic benefit for the treatment of psychosis. The primary objectives of this study are to continue the safety evaluation of M100907 in the treatment of subjects with schizophrenia or schizoaffective disorder who participated in Protocol HMR 3001. The secondary objectives of this study are to: 1) evaluate the long-term efficacy of M100907 as monotherapy for symptom control in subjects with schizophrenia and schizoaffective disorder who participated in Protocol HMR 3001. 2) to continue to evaluate the effects of M100907 on the cognitive deficits associated with schizophrenia and schizoaffective disorder. 3) to assess the impact of M100907 on quality of life scores longitudinally using the Heinrichs-Hanlon-Carpenter Quality of Life Scale (QLS) and the Scale to measure Subjective Well-Being Under Neuroleptic Treatment (SWN). 4) to measure the impact of M100907 resource utilization associated with long-term treatment with M100907. This is a multicenter, long-term, safety follow-up, open-label trial of once-daily dosing of M100907 as monotherapy in the treatment of subjects with schizophrenia or schizoaffective disorder. The GCRC nursing staff will assist with performing EKG's, collecting blood and urine samples, and sample processing.

Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
37
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gibson, Kelly S; Stark, Sydney; Kumar, Deepak et al. (2017) The relationship between gestational age and the severity of neonatal abstinence syndrome. Addiction 112:711-716

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