Back to resultsSPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
[123]I-CNS 1261
Lorazepam
Risperidone
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia focused on measuring schizophrenic patients, SPET, NMDA receptor, ligand [123]I-CNS 1261
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00364429
Brief Title
SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
terminated
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenic patients, SPET, NMDA receptor, ligand [123]I-CNS 1261
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
[123]I-CNS 1261
Intervention Description
Study Drug
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
Study Drug
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
[123]I-CNS 1261, Lorazepam
Intervention Description
Study Drug
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
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