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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ABT-436

Matching Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Pregnant or breast-feeding female.
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.
Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2.
Positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Pharmacology assays

Hormones in blood, urine and saliva samples

ABT-436 drug levels

ABT-436 drug levels in plasma

Vital signs

Blood pressure, pulse

Clinical safety labs

Hematology, chemistry, urinalysis

Secondary Outcome Measures

Psychiatric symptom scales

Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale

Full Information

NCT ID

NCT01380704

First Posted

June 1, 2011

Last Updated

November 17, 2017

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01380704

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ABT-436

Intervention Description

QD Days 1-7

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

QD Days 1-7

Primary Outcome Measure Information:

Title

Pharmacology assays

Description

Hormones in blood, urine and saliva samples

Time Frame

Days -2, -1, 6, 7

Title

ABT-436 drug levels

Description

ABT-436 drug levels in plasma

Time Frame

Days 6, 7

Title

Vital signs

Description

Blood pressure, pulse

Time Frame

Days -2 through 8, 14, 30

Title

Clinical safety labs

Description

Hematology, chemistry, urinalysis

Time Frame

Days -2, 2, 5, 8

Secondary Outcome Measure Information:

Title

Psychiatric symptom scales

Description

Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale

Time Frame

Days -2, 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Pregnant or breast-feeding female. 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. Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2. Positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine Tracy, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

28293470

Citation

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.

Results Reference

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

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