Status:
COMPLETED
Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Depression
Eligibility:
All Genders
55-80 years
Phase:
PHASE1
Brief Summary
This study is designed to characterize the regional distribution of \[11C\] ABP688 in brain by positron emission tomography (PET).
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01528241
Start Date
August 1 2008
End Date
May 1 2010
Last Update
December 8 2020
Active Locations (2)
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1
Novartis Investigative Site
New York, New York, United States
2
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States