Depression
Conditions
Keywords
ABP688, Tracer, Depression
Brief summary
This study is designed to characterize the regional distribution of \[11C\] ABP688 in brain by positron emission tomography (PET).
Interventions
DRUGABP688
Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binding of [11C] ABP688 to mGlu5 receptors | Day 1 | Binding of \[11C\]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes |
| Blood levels of [11C] ABP688 | Day 1, up to 60 minutes | Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of \[11C\] ABP688. Specific times are recorded at the clinical site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in [11C]ABP688 binding to mGlu5 receptors | Day 1 | Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients. |
Countries
United States
Outcome results
None listed