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
1 other identifier
interventional
51
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 major-depressive-disorder
Started Jun 2011
Shorter than P25 for phase_1 major-depressive-disorder
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedNovember 21, 2017
November 1, 2011
3 months
June 1, 2011
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Psychiatric symptom scales
Days -2, 7
Study Arms (2)
Active
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related 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: 10.1002/brb3.628. eCollection 2017 Mar.
PMID: 28293470RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Katherine Tracy, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 27, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
November 21, 2017
Record last verified: 2011-11