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Clinical Trials/NCT01380704
NCT01380704CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of ABT-436 in Major Depressive Disorder Subjects

AbbVie0 sites51 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
51
Primary Endpoint
Clinical safety labs

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Active

Experimental

Intervention: ABT-436 (Drug)

Placebo

Placebo Comparator

Intervention: Matching Placebo (Drug)

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)

Investigators

Sponsor
AbbVie
Sponsor Class
Industry
Responsible Party
Sponsor

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