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SPECT Imaging of Nicotinic Receptors in Schizophrenia
NCT00061789Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2003
- Countries
- 1
- Sponsor
- National Institute of Mental Health
- Modality
- Small Molecules
- Drugs
- [123I] 5-IA
- Conditions
- schizophrenia
01
Overview
Phase 2, open-label trial of [123I] 5-IA in schizophrenia (5 arms), sponsored by National Institute of Mental Health. Primary endpoint: [(123)I]5-I-A-85380 binding to Alpha 4 Beta 2 nicotinic acetylcholine receptors. Started Feb 2003; status: completed.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
Controls-Group 1
Healthy non-smokers (21-80 years)
Smoker Patients-Group 2
Schizophrenia patients who smoke (21-50 years)
Non-Smoker Patients-Group 3
Schizophrenia patients who do not smoke (21-50 years)
Smoker Controls-Group 4
Healthy smokers (21-50 years)
Non-Smoker Controls-Group 5
Healthy non-smokers (21-50 years)
03
Who it enrols
Healthy volunteers and schizophrenia patients aged 21-80. Schizophrenia patients must be on stable doses of olanzapine or risperidone for >6 months. Participants are stratified by smoking status (smokers >20/day for >5 years vs non-smokers).
04
Endpoints
Primary
[(123)I]5-I-A-85380 binding to Alpha 4 Beta 2 nicotinic acetylcholine receptors
Secondary
Relationship between psychiatric symptoms or cognitive dysfunction and SPECT measurement
Test-retest reliability of the SPECT measurement
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