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

NCT ID: NCT00364429

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2005-07-31

Brief 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).

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

[123]I-CNS 1261

Study Drug

Intervention Type: DRUG

Lorazepam

Study Drug

Intervention Type: DRUG

Risperidone

Study Drug

Intervention Type: DRUG

Other Intervention Names

[123]I-CNS 1261; Lorazepam

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Barcelona, , Spain

Countries

Spain

Other Identifiers

102747

Identifier Type: -

Identifier Source: org_study_id