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

August 11, 2006
March 17, 2011
July 2005
Not Provided
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 ]
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.
Complete list of historical versions of study NCT00364429 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Schizophrenia
  • Drug: [123]I-CNS 1261
  • Drug: Lorazepam
  • Drug: Risperidone
    Other Names:
    • [123]I-CNS 1261
    • Lorazepam
    • Risperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
55
Not Provided
Not Provided

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00364429
102747
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP