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Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Primary Purpose

Depression

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EVT 101
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Treatment-Resistant Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evotec Study Site 6
  • Evotec Study Site 19
  • Evotec Study Site 15
  • Evotec Study Site 4
  • Evotec Study Site 14
  • Evotec Study Site 3
  • Evotec Study Site 2
  • Evotec Study Site 1
  • Evotec Study Site 8
  • Evotec Study Site 5
  • Evotec Study Site 9
  • Evotec Study Site 13
  • Evotec Study Site 7
  • Evotec Study Site 12

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

EVT 101

Arm Description

Placebo

EVT 101

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Percentage of patients who respond to treatment with study drug
Percentage of patients who experience remission

Full Information

First Posted
May 19, 2010
Last Updated
March 1, 2016
Sponsor
Janssen Research & Development, LLC
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01128452
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Treatment-Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
EVT 101
Arm Type
Experimental
Arm Description
EVT 101
Intervention Type
Drug
Intervention Name(s)
EVT 101
Intervention Description
HPMC Capsule, 15 mg, once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
HPMC Placebo capsules, once daily for 28 days
Primary Outcome Measure Information:
Title
Safety and Tolerability Profile of EVT 101
Description
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
Time Frame
28 days of EVT 101-Treatment
Secondary Outcome Measure Information:
Title
Efficacy of EVT 101 in depression measured using the MADRS score
Description
Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline
Time Frame
28 days
Title
Percentage of patients who respond to treatment with study drug
Time Frame
4 weeks
Title
Percentage of patients who experience remission
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Greiling, PhD
Organizational Affiliation
Evotec AG
Official's Role
Study Director
Facility Information:
Facility Name
Evotec Study Site 6
City
Oceanside
State/Province
California
Country
United States
Facility Name
Evotec Study Site 19
City
San Diego
State/Province
California
Country
United States
Facility Name
Evotec Study Site 15
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Evotec Study Site 4
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Evotec Study Site 14
City
Smyrna
State/Province
Georgia
Country
United States
Facility Name
Evotec Study Site 3
City
Beachwood
State/Province
Illinois
Country
United States
Facility Name
Evotec Study Site 2
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Evotec Study Site 1
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Evotec Study Site 8
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
Evotec Study Site 5
City
Willingboro
State/Province
New Jersey
Country
United States
Facility Name
Evotec Study Site 9
City
New York
State/Province
New York
Country
United States
Facility Name
Evotec Study Site 13
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Evotec Study Site 7
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Evotec Study Site 12
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

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