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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 11, 2006

Last Updated Date

October 9, 2008

Start Date ^†

July 2005

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00364429 on ClinicalTrials.gov Archive Site

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study

Condition ^†

Schizophrenia

Intervention ^†

Drug: Lorazepam
Drug: Risperidone
Drug: [123]I-CNS 1261

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

Primary Completion Date

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 to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00364429

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.