Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
- Registration Number
- NCT01380704
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active ABT-436 - Placebo Matching Placebo -
- Primary Outcome Measures
Name Time Method Clinical safety labs Days -2, 2, 5, 8 Hematology, chemistry, urinalysis
ABT-436 drug levels Days 6, 7 ABT-436 drug levels in plasma
Vital signs Days -2 through 8, 14, 30 Blood pressure, pulse
Pharmacology assays Days -2, -1, 6, 7 Hormones in blood, urine and saliva samples
- Secondary Outcome Measures
Name Time Method Psychiatric symptom scales Days -2, 7 Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale