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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00364429
• Other study ID #: 102747
• Status: Terminated
• Phase: Phase 1
• First received: August 11, 2006
• Last updated: January 7, 2016
• Start date: July 2005
• Est. completion date: July 2005

Study information

• Verified date: January 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		throughout the study
Secondary	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.		throughout the study