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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: [123]I-CNS 1261 (Drug); Lorazepam (Drug); Risperidone (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline


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).

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: 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.

Secondary outcome: 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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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.

Locations and Contacts

GSK Investigational Site, Barcelona, Spain
Additional Information

Starting date: July 2005
Last updated: March 17, 2011

Page last updated: August 23, 2015

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