Changes in Striatal [11C]ORM-13070 Binding Elicited by Changing Levels of Endogenous Noradrenaline (AIMI2)
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|ClinicalTrials.gov Identifier: NCT01794975|
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Changes in Striatal [11C]ORM-13070 Binding.||Drug: Ketamine Drug: Atomoxetine Other: Cold pressor test Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Changes in Striatal [11C]ORM-13070 Binding Elicited by Changing Levels of Endogenous Noradrenaline - a PET Study in Healthy Human Subjects|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Ketamine
Ketamine will be administered intravenously using a pseudo steady state infusion approach with a target plasma concentration of 300 ng/ml starting 15 minutes before the PET scan and continued throughout the scan.
Other Name: Ketalar
Active Comparator: Atomoxetine and the cold pressor test
An oral dose of approximately 1.2 mg/kg (range, 1.12-1.26 mg/kg) of atomoxetine is administered 1 h before the PET scans. A cold pressor test is employed as a physiological noradrenergic stimulus. The subject's foot is placed in a 8 °C water basin for the duration of the PET scan.
Other Name: Strattera
Other: Cold pressor test
Other Name: Cold stimulation of the subject's foot
Placebo Comparator: Placebo
Placebo capsules are given to mimic the atomoxetine treatment at each treatment visit except the atomoxetine visit. A baseline PET scan with [11C]ORM-13070 will be performed for all subjects with the placebo treatment only.
- Receptor occupancy [ Time Frame: 5-30 minutes ]Alpha2C-adrenoceptor occupancy in the striatum will be assessed by comparing the amount of tracer uptake during the control scan to the amount of tracer uptake during the noradrenaline challenges. This assessment will be made once the results of all 3 scans are available for each subject.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794975
|Clinical Research Services Turku (CRST) / Turku PET Centre|
|Principal Investigator:||Juha Rinne, PhD||Turku PET Centre|