Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ABT-436; Drug: Matching Placebo

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder.

4. Mild-to-moderate depressive symptoms at Screening. 5. A condition of general good physical health. Exclusion Criteria

1. Pregnant or breast-feeding female.
2. Use of any medication within 4 weeks prior to Day -2, unless the dose has been stable for 4 weeks, no dose change is anticipated during the study, and the medication is specifically allowed for this study, OR prior as needed (PRN) use of the medication is specifically allowed for this study.
3. Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2.
4. Positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking.
5. A current or past history of major depressive disorder with psychotic features, bipolar disorder, schizophrenia or other psychotic disorder, mental retardation, or mental disorder due to a general medical condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching Placebo; QD Days 1-7
Experimental: Active	Drug: ABT-436; QD Days 1-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacology assays	Hormones in blood, urine and saliva samples	Days -2, -1, 6, 7
ABT-436 drug levels	ABT-436 drug levels in plasma	Days 6, 7
Vital signs	Blood pressure, pulse	Days -2 through 8, 14, 30
Clinical safety labs	Hematology, chemistry, urinalysis	Days -2, 2, 5, 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychiatric symptom scales	Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale	Days -2, 7

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Katherine Tracy, MD, Abbott

Publications and helpful links

General Publications

• Katz DA, Locke C, Greco N, Liu W, Tracy KA. Hypothalamic-pituitary-adrenal axis and depression symptom effects of an arginine vasopressin type 1B receptor antagonist in a one-week randomized Phase 1b trial. Brain Behav. 2017 Feb 9;7(3):e00628. doi: 10.1002/brb3.628. eCollection 2017 Mar.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: M12-674