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

This study has been terminated.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 11, 2006
Last updated: January 7, 2016
Last verified: January 2016
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).

Condition Intervention Phase
Drug: [123]I-CNS 1261
Drug: Lorazepam
Drug: Risperidone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • 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. [ Time Frame: throughout the study ]

Enrollment: 55
Study Start Date: July 2005
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [123]I-CNS 1261
    Study Drug
    Drug: Lorazepam
    Study Drug
    Drug: Risperidone
    Study Drug
    Other Names:
    • [123]I-CNS 1261
    • Lorazepam

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00364429

GSK Investigational Site
Barcelona, Spain
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00364429     History of Changes
Other Study ID Numbers: 102747 
Study First Received: August 11, 2006
Last Updated: January 7, 2016
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:
schizophrenic patients
NMDA receptor
ligand [123]I-CNS 1261

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Anti-Anxiety Agents
Autonomic Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 22, 2016