A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of ABT-436 in Major Depressive Disorder Subjects
Overview
- Phase
- Phase 1
- Intervention
- ABT-436
- Conditions
- Major Depressive Disorder
- Sponsor
- AbbVie
- Enrollment
- 51
- Primary Endpoint
- Clinical safety labs
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active
Intervention: ABT-436
Placebo
Intervention: Matching Placebo
Outcomes
Primary Outcomes
Clinical safety labs
Time Frame: Days -2, 2, 5, 8
Hematology, chemistry, urinalysis
ABT-436 drug levels
Time Frame: Days 6, 7
ABT-436 drug levels in plasma
Vital signs
Time Frame: Days -2 through 8, 14, 30
Blood pressure, pulse
Pharmacology assays
Time Frame: Days -2, -1, 6, 7
Hormones in blood, urine and saliva samples
Secondary Outcomes
- Psychiatric symptom scales(Days -2, 7)