Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)

Completed · Phase 1

Conditions studied: Depression

In brief

This study is designed to characterize the regional distribution of \[11C\] ABP688 in brain by positron emission tomography (PET).

Key facts

Study ID

NCT01528241

Run by

Novartis Pharmaceuticals

People needed

42

Starts

2008-08-01

Expected to finish

2010-05-01

Last updated by the study team

2020-12-08

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects 55-80 (inclusive)
• Subjects in good health
• At screening:
• oral body temperature between 35-37.5C
• systolic blood pressure: 90-140 mm Hg
• diastolic blood pressure: 50-90 mm Hg
• pulse rate: 40-90 bpm
• Female subjects of child bearing potential must have been using a double-barrier local contraception
• Postmenopausal women must have had no menstrual bleeding
• Subjects must have weighed at least 50 kg
• All subjects must provide informed consent
• All subjects must have been able to communicate well with investigator
• Specific to Major depression disorder (MDD)
• Patients had to show following level of symptomatology:
• HAM-D (17-item scale) > 16
• CGI > 4 (moderately ill)

You may not qualify if…

• Specific criteria for healthy volunteers:
• Presence and/or history of clinically significant major neurological or psychiatric disorder
• Specific criteria for MDD patients:
• Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
• Axis I co-morbidity was excluded except anxiety spectrum disorders
• Criteria for both:
• Smokers
• Pregnancy
• Subjects with history of or symptoms/complaints consistent with mild cognitive impairment
• Use of any psychotropic prescription drugs
• Coffee consumers more than 6 cups/day
• Participation in any clinical investigation
• Donation or loss of 400 mL or more of blood
• Significant illness within 2 weeks prior to dosing
• A known hypersensitivity to study drug
• MRI scan that showed evidence of stroke
• Any surgical or medical condition which might have significantly altered distribution
• Clinical evidence of any abnormal lab value
• History of immunodeficiency disease
• Positive Hepatitis B surface antigen
• Presence of contraindications to PET scan investigations- Presence of contraindications to MRI investigations
• Evidence from an Allen test of incomplete communication
• History of drug or alcohol abuse
• Current use of anticonvulsant
• Significant radiation exposure

Where it is running

• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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