SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
Overview[ - collapse ][ - ]
| 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 | Schizophrenia |
| Intervention | Drug: [123]I-CNS 1261 Drug: Lorazepam Drug: Risperidone |
| Phase | Phase 1 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00364429 |
| First Received | August 11, 2006 |
| Last Updated | March 17, 2011 |
| Last verified | March 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 11, 2006 |
|---|---|
| Last Updated Date | March 17, 2011 |
| Start Date | July 2005 |
| Estimated Primary Completion Date | Not Provided |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic |
| Condition | Schizophrenia |
| Intervention | Drug: [123]I-CNS 1261 Drug: Lorazepam Drug: Risperidone Other Names:
|
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 55 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00364429 |
|---|---|
| Other Study ID Numbers | 102747 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials, MD GlaxoSmithKline |
| Verification Date | March 2011 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Barcelona, Spain |
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