This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study.
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study. Fifty subjects will receive study drug for seven days. Thirty subjects will receive ABT-436 and twenty subjects will receive placebo. Blood, urine and saliva samples will be obtained, both before and during study drug administration, to measure ABT-436 pharmacology. Safety will be assessed throughout the study, including at two follow-up visits after completion of study drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
QD Days 1-7
QD Days 1-7
Pharmacology assays
Hormones in blood, urine and saliva samples
Time frame: Days -2, -1, 6, 7
ABT-436 drug levels
ABT-436 drug levels in plasma
Time frame: Days 6, 7
Vital signs
Blood pressure, pulse
Time frame: Days -2 through 8, 14, 30
Clinical safety labs
Hematology, chemistry, urinalysis
Time frame: Days -2, 2, 5, 8
Psychiatric symptom scales
Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale
Time frame: Days -2, 7
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