Last updated: 11/02/2018 23:53:07
SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia
GSK study ID
102747
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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
Trial description: 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).
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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.
Timeframe: throughout the study
Secondary outcomes:
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.
Timeframe: throughout the study
Interventions:
Drug: [123]I-CNS 1261
Drug: Lorazepam
Drug: Risperidone
Enrollment:
55
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
SB773812
Collaborators
Not applicable
Study date(s)
July 2005 to November 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Right-handed
- Smoker
- Any clinically or laboratory significant abnormality.
- Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2007-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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