SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: [123]I-CNS 1261 (Drug); Lorazepam (Drug); Risperidone (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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).
Clinical Details
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
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacodynamics Study
Primary outcome: CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients.
Secondary outcome: Effect of treatment with risperidone and lorazepam in inducing changes on [123]I CNS 1261 binding, and its relationship with the plasma concentration of administered drugs and with Psychopathological scales scores.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Right-handed
- Smoker
- Healthy volunteer or schizophrenic patients as diagnosed by DSM IV criteria.
- Treatment naive patients or with Risperidone treatment for 2 months that have not
received any depot neuroleptic during the last year.
- Women of childbearing potential must agree to acceptable method of birth control.
Exclusion criteria:
- Any clinically or laboratory significant abnormality.
- Subjects receiving a radiation dose from other activities of more than 10 mSv over any
3 year period.
- Heart pacemaker, metallic prosthesis or other metallic body implants.
- History or presence of CNS conditions.
- History of substance dependence.
- History of or suffers from claustrophobia.
- Positive test for HBV (hepatitis B virus), HCV (hepatitis C virus) or HIV.
- Pregnant or lactating women.
Locations and Contacts
GSK Clinical Trials Call Center, Barcelona 08950, Spain
GSK Clinical Trials Call Center, Barcelona 08025, Spain
GSK Clinical Trials Call Center, Barcelona 08036, Spain
GSK Clinical Trials Call Center, Barcelona 08003, Spain
GSK Clinical Trials Call Center, Barcelona 08035, Spain
Additional Information
Starting date: July 2005
Last updated: September 7, 2007
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