Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128452
• Other study ID #: CR104589
• Secondary ID: RRA-12001, EVT 1
• Status: Terminated
• Phase: Phase 2
• First received: May 19, 2010
• Last updated: January 4, 2016
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Drug:
• EVT 101
HPMC Capsule, 15 mg, once daily for 28 days
• Placebo
HPMC Placebo capsules, once daily for 28 days

Locations

Country	Name	City	State
United States	Evotec Study Site 4	Atlanta	Georgia
United States	Evotec Study Site 1	Baltimore	Maryland
United States	Evotec Study Site 3	Beachwood	Illinois
United States	Evotec Study Site 7	Dallas	Texas
United States	Evotec Study Site 8	Flowood	Mississippi
United States	Evotec Study Site 12	Houston	Texas
United States	Evotec Study Site 9	New York	New York
United States	Evotec Study Site 2	Oak Brook	Illinois
United States	Evotec Study Site 6	Oceanside	California
United States	Evotec Study Site 13	Oklahoma City	Oklahoma
United States	Evotec Study Site 19	San Diego	California
United States	Evotec Study Site 14	Smyrna	Georgia
United States	Evotec Study Site 15	Tampa	Florida
United States	Evotec Study Site 5	Willingboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability Profile of EVT 101	AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires	28 days of EVT 101-Treatment	Yes
Secondary	Efficacy of EVT 101 in depression measured using the MADRS score	Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline	28 days	No
Secondary	Percentage of patients who respond to treatment with study drug		4 weeks	No
Secondary	Percentage of patients who experience remission		4 weeks	No