Working... Menu

Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128452
Recruitment Status : Terminated (Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA)
First Posted : May 21, 2010
Last Update Posted : March 28, 2016
Hoffmann-La Roche
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Depression Drug: EVT 101 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
HPMC Placebo capsules, once daily for 28 days

Experimental: EVT 101
EVT 101
Drug: EVT 101
HPMC Capsule, 15 mg, once daily for 28 days

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

Secondary Outcome Measures :
  1. Efficacy of EVT 101 in depression measured using the MADRS score [ Time Frame: 28 days ]
    Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline

  2. Percentage of patients who respond to treatment with study drug [ Time Frame: 4 weeks ]
  3. Percentage of patients who experience remission [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01128452

Layout table for location information
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
Layout table for investigator information
Study Director: Doris Greiling, PhD Evotec AG

Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC Identifier: NCT01128452     History of Changes
Other Study ID Numbers: CR104589
RRA-12001, EVT 101/1012 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

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

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