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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01380704
First received: June 1, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: ABT-436
Drug: Matching Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of ABT-436 in Major Depressive Disorder Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacology assays [ Time Frame: Days -2, -1, 6, 7 ] [ Designated as safety issue: No ]
    Hormones in blood, urine and saliva samples

  • ABT-436 drug levels [ Time Frame: Days 6, 7 ] [ Designated as safety issue: No ]
    ABT-436 drug levels in plasma

  • Vital signs [ Time Frame: Days -2 through 8, 14, 30 ] [ Designated as safety issue: Yes ]
    Blood pressure, pulse

  • Clinical safety labs [ Time Frame: Days -2, 2, 5, 8 ] [ Designated as safety issue: Yes ]
    Hematology, chemistry, urinalysis


Secondary Outcome Measures:
  • Psychiatric symptom scales [ Time Frame: Days -2, 7 ] [ Designated as safety issue: No ]
    Hamilton depression scale, Mood and anxiety symptom questionnaire, Perceived stress scale


Enrollment: 51
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: ABT-436
QD Days 1-7
Placebo Comparator: Placebo Drug: Matching Placebo
QD Days 1-7

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380704

Locations
United States, California
Site Reference ID/Investigator# 52564
Glendale, California, United States, 91206
Site Reference ID/Investigator# 51744
Long Beach, California, United States, 90806
United States, Florida
Site Reference ID/Investigator# 51746
South Miami, Florida, United States, 33143
United States, Kansas
Site Reference ID/Investigator# 52566
Overland Park, Kansas, United States, 66212
United States, Texas
Site Reference ID/Investigator# 51743
Austin, Texas, United States, 78731
Sponsors and Collaborators
Abbott
Investigators
Study Director: Katherine Tracy, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01380704     History of Changes
Other Study ID Numbers: M12-674
Study First Received: June 1, 2011
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014