Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

This study has been terminated.
(Patient recruitment)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01128452
First received: May 19, 2010
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Depression
Drug: EVT 101
Drug: Placebo
Phase 2

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

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Safety and Tolerability Profile of EVT 101 [ Time Frame: 28 days of EVT 101-Treatment ] [ Designated as safety issue: Yes ]
    AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires


Secondary Outcome Measures:
  • Efficacy of EVT 101 in depression measured using the MADRS score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline

  • Percentage of patients who respond to treatment with study drug [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who experience remission [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
HPMC Placebo capsules, once daily for 28 days
Other Name: Placebo
Experimental: EVT 101
EVT 101
Drug: EVT 101
HPMC Capsule, 15 mg, once daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01128452

Locations
United States, California
Evotec Study Site 6
Oceanside, California, United States
Evotec Study Site 19
San Diego, California, United States
United States, Florida
Evotec Study Site 15
Tampa, Florida, United States
United States, Georgia
Evotec Study Site 4
Atlanta, Georgia, United States
Evotec Study Site 14
Smyrna, Georgia, United States
United States, Illinois
Evotec Study Site 3
Beachwood, Illinois, United States
Evotec Study Site 2
Oak Brook, Illinois, United States
United States, Maryland
Evotec Study Site 1
Baltimore, Maryland, United States
United States, Mississippi
Evotec Study Site 8
Flowood, Mississippi, United States
United States, New Jersey
Evotec Study Site 5
Willingboro, New Jersey, United States
United States, New York
Evotec Study Site 9
New York, New York, United States
United States, Oklahoma
Evotec Study Site 13
Oklahoma City, Oklahoma, United States
United States, Texas
Evotec Study Site 7
Dallas, Texas, United States
Evotec Study Site 12
Houston, Texas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Hoffmann-La Roche
Investigators
Study Director: Doris Greiling, PhD Evotec AG
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01128452     History of Changes
Other Study ID Numbers: CR104589, RRA-12001, EVT 101/1012
Study First Received: May 19, 2010
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Treatment-Resistant Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014