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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00364429

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	Intervention	Phase
Schizophrenia	Drug: Lorazepam Drug: Risperidone Drug: [123]I-CNS 1261	Phase I

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Lorazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
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

Further study details as provided by GlaxoSmithKline:

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 ]

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 ]

Enrollment:	55
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364429

Locations

Spain
GSK Investigational Site
Barcelona, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	102747
Study First Received:	August 11, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00364429 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

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

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Healthy
Antipsychotic Agents
Serotonin
Schizophrenia

Lorazepam
Dopamine
Mental Disorders
Hypnotics and Sedatives
Dopamine Agents
Psychotic Disorders
Anti-Anxiety Agents
Peripheral Nervous System Agents
Anticonvulsants
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Schizophrenia
Lorazepam
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents

Risperidone
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
GABA Agents
Dopamine Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009