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

This study has been terminated.
(terminated)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00364429
First received: August 11, 2006
Last updated: March 17, 2011
Last verified: March 2011
History of Changes
  Purpose

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
Schizophrenia
 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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
Intervention Details:
    Drug: [123]I-CNS 1261 Drug: Lorazepam Drug: Risperidone
    Other Names:
    • [123]I-CNS 1261
    • Lorazepam
    • Risperidone
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364429

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00364429     History of Changes
Other Study ID Numbers: 102747
Study First Received: August 11, 2006
Last Updated: March 17, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Lorazepam
Risperidone
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013