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29 results on '"Schotte, Alain"'

1. Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system

Author

Alphs, Larry, primary, Turkoz, Ibrahim, additional, Smith-Swintosky, Virginia, additional, Keenan, Alexander, additional, Abraham, Emily, additional, Schotte, Alain, additional, Hooker, Eileen, additional, Damascene Iyamuremye, Jean, additional, Kayiteshonga, Yvonne, additional, Bizoza, Rutakayile, additional, and Mancevski, Branislav, additional

Published
2023
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3. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia

Author

Najarian, Dean, primary, Sanga, Panna, additional, Wang, Steven, additional, Lim, Pilar, additional, Singh, Arun, additional, Robertson, Mary Jane, additional, Cohen, Kristin, additional, Schotte, Alain, additional, Milz, Ruth, additional, Venkatasubramanian, Raja, additional, T’Jollyn, Huybrecht, additional, Walling, David P, additional, Galderisi, Silvana, additional, and Gopal, Srihari, additional

Published
2021
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5. Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.

Author

Najarian, Dean, Sanga, Panna, Wang, Steven, Lim, Pilar, Singh, Arun, Robertson, Mary Jane, Cohen, Kristin, Schotte, Alain, Milz, Ruth, Venkatasubramanian, Raja, T'Jollyn, Huybrecht, Walling, David P, Galderisi, Silvana, and Gopal, Srihari

Subjects
PEOPLE with schizophrenia, DISEASE relapse, CLINICAL trials, MEDICAL screening, SAFETY
Abstract

Background This double-blind (DB), randomized, parallel-group study was designed to evaluate efficacy and safety of paliperidone palmitate 6-month (PP6M) formulation relative to paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia. Methods Following screening, patients entered an open-label (OL) maintenance phase and received 1 injection cycle of paliperidone palmitate 1-month (PP1M; 100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). Clinically stable patients were randomized (2:1) to receive PP6M (700 or 1000 mg eq. gluteal injections) or PP3M (350 or 525 mg eq.) in a 12-month DB phase; 2 doses of PP6M (corresponding to doses of PP1M and PP3M) were chosen. Results Overall, 1036 patients were screened, 838 entered the OL phase, and 702 (mean age: 40.8 years) were randomized (PP6M: 478; PP3M: 224); 618 (88.0%) patients completed the DB phase (PP6M: 416 [87.0%]; PP3M: 202 [90.2%]). Relapse rates were PP6M, 7.5% (n = 36) and PP3M, 4.9% (n = 11). The Kaplan-Meier estimate of the difference (95% CI) between treatment groups (PP6M − PP3M) in the percentages of patients who remained relapse free was −2.9% (−6.8%, 1.1%), thus meeting noninferiority criteria (95% CI lower bound is larger than the pre-specified noninferiority margin of −10%). Secondary efficacy endpoints corroborated the primary analysis. Incidences of treatment-emergent adverse events were similar between PP6M (62.1%) and PP3M (58.5%). No new safety concerns emerged. Conclusions The efficacy of a twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M. Trial Registration Clinical Trials.gov identifier: NCT03345342 [ABSTRACT FROM AUTHOR]

Published
2022
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17. Interaction of antipsychotic drugs with neurotransmitter receptor sites in vitro and in vivo in relation to pharmacological and clinical effects: role of 5HT2 receptors

Author

Leysen, Josée, Janssen, Paul, Schotte, Alain, Luyten, Walter, and Megens, Anton

Abstract

In the introductory section an overview is given of the strategies which have been proposed in the search for side-effect free antipsychotics. Special attention is paid to the role of predominant 5HT2 receptor blockade over D2 blockade. Whereas D2 receptor blockade seems to be essential for the treatment of positive symptoms of schizophrenia, it also underlies the induction of extrapyramidal side effects (EPS). Predominant 5HT2 receptor blockade may reduce the EPS liability and can ameliorate negative symptoms of schizophrenia. We further report a nearly complete list of neuroleptics that are on the European market and eight new antipsychotics that recently entered clinical trial, 5HT2 and D2 receptor binding affinity (Ki values) and the rank order in affinity for various neurotransmitter receptor subtypes are also discussed. For the eight new antipsychotics and for six reference compounds the complete receptor binding profile (including 33 radioligand receptor binding and neurotransmitter uptake models) is reported. Furthermore, for a series of 120 compounds the relative affinity for D2 receptors and D3 receptors (a recently cloned new dopamine receptor subtype) is compared. Finally, original findings are reported for the new antipsychotic risperidone and for haloperidol and clozapine on the in vivo occupation of neurotransmitter receptors in various brain areas after systemic treatment of rats or guinea pigs. The receptor occupation by the drugs was measured ex vivo by quantitative receptor autoradiography. The receptor occupancy was related to the motor activity effects of the test compounds (measurements were done in the same animals) and to the ability of the drugs to antagonize various 5HT2 and D2 receptor mediated effects. With risperidone a high degree of central 5HT2 receptor occupation was achieved before other neurotransmitter receptors became occupied. This probably co-underlies the beneficial clinical properties of the drug. Antagonism of the various D2 receptor-mediated effects was achieved at widely varying degrees of D2 receptor occupancy, from just about 10% to more than 70%. For therapeutic application it may be of prime importance to carefully titrate drug dosages. Antipsychotic effects may be achieved at a relatively low degree of D2 receptor occupancy at which motor disturbances are still minimal. With drugs such as risperidone that produce shallow log dose-effect curves, differentiation between the various D2 receptor mediated effects may be made more easily, allowing EPS-free maintenance therapy of schizophrenic patients.

Published
1993
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18. Characterization of brain neurotensin receptors using a new tool : levocabastine

Author

UCL - MD/FSIO/FARL - Laboratoire de pharmacologie expérimentale, Laduron, Pierre M., Maloteaux, Jean-Marie, Schotte, Alain, UCL - MD/FSIO/FARL - Laboratoire de pharmacologie expérimentale, Laduron, Pierre M., Maloteaux, Jean-Marie, and Schotte, Alain

Abstract

Levocabastine, a non-peptide antihistamine compound, inhibits, with high affinity and selectivity, neurotensin binding to the low affinity neurotensin sites (NTL-sites) in rat, mouse and hamster brain but not in various other mammalian species including man. The use of levocabastine enable to study separately the binding of radiolabelled neurotensin to the high affinity neurotensin binding sites (NTH-sites) and to the NTL-sites. NTH-sites are densely present in the substantia nigra, ventral tegmental area, cingulated cortex, entorhinal cortex, olfactory bulb, rhinal sulcus, superior colliculis and ventral dentate gyrus. They display the properties of a neurotransmitter receptor binding site and should be considered as the physiologically relevant neurotensin receptor. NTH-sites are situated on dopaminergic nerve ending both in the nigrostriatal and mesolimbic pathways. NTH- and NTL-sites are not high and low affinity states of a same receptor, since both neurotensin binding sites show different subcellular distribution patterns after isopycnic centrifugation in sucrose density gradients. Although they show strict stereospecific properties, NTL-sites have, as yet, no defined functional role and are likely to be considered as chemical recognition sites for neurotensin and for levocabastine. NTL-sites are homogeneously present in the various brain areas of the rat brain. They are distinct entities and have no relationship with the histamine-H1 receptors. NTL-sites are suggested to be localized on glial cells. During the ontogenic development, NTJ-sites peak in most brain areas between the 5th and the 10th day of postnatal life. They are then predominant in the cortical areas, but subsequently dramatically regress in many brain areas. In the substantia nigra NTH-sites peak at 15 days and slightly decrease in adulthood. NTL-sited start to appear only from the 15th day of life. Evidence is given herewith that only the NTH-sites can be in, Thèse de doctorat en sciences biomédicales -- UCL, 1989

Published
1989

29. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.

Author

Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, and Gopal S

Subjects
Adult, Double-Blind Method, Humans, Paliperidone Palmitate adverse effects, Recurrence, Antipsychotic Agents adverse effects, Schizophrenia chemically induced, Schizophrenia drug therapy
Abstract

Background: This double-blind (DB), randomized, parallel-group study was designed to evaluate efficacy and safety of paliperidone palmitate 6-month (PP6M) formulation relative to paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia., Methods: Following screening, patients entered an open-label (OL) maintenance phase and received 1 injection cycle of paliperidone palmitate 1-month (PP1M; 100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). Clinically stable patients were randomized (2:1) to receive PP6M (700 or 1000 mg eq., gluteal injections) or PP3M (350 or 525 mg eq.) in a 12-month DB phase; 2 doses of PP6M (corresponding to doses of PP1M and PP3M) were chosen., Results: Overall, 1036 patients were screened, 838 entered the OL phase, and 702 (mean age: 40.8 years) were randomized (PP6M: 478; PP3M: 224); 618 (88.0%) patients completed the DB phase (PP6M: 416 [87.0%]; PP3M: 202 [90.2%]). Relapse rates were PP6M, 7.5% (n = 36) and PP3M, 4.9% (n = 11). The Kaplan-Meier estimate of the difference (95% CI) between treatment groups (PP6M - PP3M) in the percentages of patients who remained relapse free was -2.9% (-6.8%, 1.1%), thus meeting noninferiority criteria (95% CI lower bound is larger than the pre-specified noninferiority margin of -10%). Secondary efficacy endpoints corroborated the primary analysis. Incidences of treatment-emergent adverse events were similar between PP6M (62.1%) and PP3M (58.5%). No new safety concerns emerged., Conclusions: The efficacy of a twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M., Trial Registration: Clinical Trials.gov identifier: NCT03345342., (© The Author(s) 2021. Published by Oxford University Press on behalf of CINP.)

Published
2022
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