Clinical trial NCT01741142: Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.


Eligibility criteria: Inclusion Criteria:

* Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
* No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
* Can safely be treated on an outpatient basis.
* A condition of general good physical health.
* Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.

Exclusion Criteria:

* History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
* Inadequate response to more than two different antidepressant medications during the current major depressive episode.
* History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
* History of transcranial magnetic stimulation during the current major depressive episode.
* Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.

Primary outcomes:
measure: Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
timeFrame: Week 6
Secondary outcomes:
measure: Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
timeFrame: Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 85593
state: Arkansas
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 87228
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 87214
state: California
city: Oakland
country: United States
facility: Site Reference ID/Investigator# 87220
state: California
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 87215
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 87225
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 85594
state: Georgia
city: Marlton
country: United States
facility: Site Reference ID/Investigator# 85580
state: New Jersey
city: Brooklyn
country: United States
facility: Site Reference ID/Investigator# 87227
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 87223
state: New York
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 87217
state: Ohio
city: Portland
country: United States
facility: Site Reference ID/Investigator# 87226
state: Oregon
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 87221
state: Pennsylvania
city: Austin
country: United States
facility: Site Reference ID/Investigator# 87219
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 87216
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 87933
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 88874
state: Utah
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 88876
state: Washington
Study officials:
affiliation: AbbVie
name: Beatrice Rendenbach-Mueller, PhD
role: STUDY_DIRECTOR
References: