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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00364429 |
This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before: Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Lorazepam Drug: Risperidone Drug: [123]I-CNS 1261 |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Investigation of the NMDA Receptor System in Man as a Potential Surrogate Marker for Deficit Syndrome in Schizophrenia: a [123]I-CNS 1261 Single Photon Emission Tomography (SPET) Study |
Enrollment: | 55 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 102747 |
Study First Received: | August 11, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00364429 |
Health Authority: | Spain: Spanish Agency of Medicines |
NMDA receptor SPET schizophrenic patients ligand [123]I-CNS 1261 |
Schizophrenia Lorazepam Dopamine Mental Disorders Risperidone |
Psychotic Disorders Healthy Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Dopamine Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |