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

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lorazepam; Risperidone

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.