SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: [123]I-CNS 1261
* Drug: Lorazepam
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [123]I-CNS 1261|Study Drug|
|Drug: Lorazepam|Study Drug|
|Drug: Risperidone|Study Drug|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPET, schizophrenic patients, NMDA receptor, ligand [123]I-CNS 1261