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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00364429
Enrollment
55
Registered
2006-08-15
Start date
2005-07-31
Completion date
2005-07-31
Last updated
2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenic patients, SPET, NMDA receptor, ligand [123]I-CNS 1261

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).

Interventions

DRUG[123]I-CNS 1261

Study Drug

DRUGLorazepam

Study Drug

DRUGRisperidone

Study Drug

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026