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

NCT00364429 | Terminated Phase 1

• 1 other identifier: 102747
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

schizophrenic patients; SPET; NMDA receptor; ligand [123]I-CNS 1261

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

[123]I-CNS 1261 DRUG

Study Drug

Lorazepam DRUG

Study Drug

Risperidone DRUG

Study Drug

Also known as: [123]I-CNS 1261, Lorazepam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Barcelona, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lorazepam; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: July 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

ES (1)