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

Phase 1TerminatedNCT00364429

GlaxoSmithKline55 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: throughout the study

Secondary Outcomes

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.