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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380704
• Other study ID #: M12-674
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2011
• Last updated: November 17, 2017
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• ABT-436
QD Days 1-7
• Matching Placebo
QD Days 1-7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

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: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacology assays	Hormones in blood, urine and saliva samples	Days -2, -1, 6, 7
Primary	ABT-436 drug levels	ABT-436 drug levels in plasma	Days 6, 7
Primary	Vital signs	Blood pressure, pulse	Days -2 through 8, 14, 30
Primary	Clinical safety labs	Hematology, chemistry, urinalysis	Days -2, 2, 5, 8
Secondary	Psychiatric symptom scales	Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale	Days -2, 7