Clinical trial NCT01128452: Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
Official title: A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depression
Keywords: Treatment-Resistant Depression
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2010-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder
* Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
* Has as score of \>/= 18 on the Ham-D-17

Exclusion Criteria:

* Pregnant or breast-feeding women
* Evidence of age-related cognitive decline or mild dementia
* At imminent risk of committing suicide
* Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
* Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
* Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening

Primary outcomes:
measure: Safety and Tolerability Profile of EVT 101
timeFrame: 28 days of EVT 101-Treatment
Secondary outcomes:
measure: Efficacy of EVT 101 in depression measured using the MADRS score
timeFrame: 28 days
measure: Percentage of patients who respond to treatment with study drug
timeFrame: 4 weeks
measure: Percentage of patients who experience remission
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Evotec Study Site 6
state: California
city: San Diego
country: United States
facility: Evotec Study Site 19
state: California
city: Tampa
country: United States
facility: Evotec Study Site 15
state: Florida
city: Atlanta
country: United States
facility: Evotec Study Site 4
state: Georgia
city: Smyrna
country: United States
facility: Evotec Study Site 14
state: Georgia
city: Beachwood
country: United States
facility: Evotec Study Site 3
state: Illinois
city: Oak Brook
country: United States
facility: Evotec Study Site 2
state: Illinois
city: Baltimore
country: United States
facility: Evotec Study Site 1
state: Maryland
city: Flowood
country: United States
facility: Evotec Study Site 8
state: Mississippi
city: Willingboro
country: United States
facility: Evotec Study Site 5
state: New Jersey
city: New York
country: United States
facility: Evotec Study Site 9
state: New York
city: Oklahoma City
country: United States
facility: Evotec Study Site 13
state: Oklahoma
city: Dallas
country: United States
facility: Evotec Study Site 7
state: Texas
city: Houston
country: United States
facility: Evotec Study Site 12
state: Texas
Study officials:
affiliation: Evotec AG
name: Doris Greiling, PhD
role: STUDY_DIRECTOR
References: