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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 1

Conditions

Schizophrenia

Treatments

Drug: Lorazepam

Drug: [123]I-CNS 1261

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00364429

102747

Details and patient eligibility

About

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).

Enrollment

55 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.