Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

March 1, 2016 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
HPMC Placebo capsules, once daily for 28 days
Experimental: EVT 101
Drug: EVT 101
HPMC Capsule, 15 mg, once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days of EVT 101-Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days
Percentage of patients who respond to treatment with study drug
Time Frame: 4 weeks
4 weeks
Percentage of patients who experience remission
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Hoffmann-La Roche

Investigators

  • Study Director: Doris Greiling, PhD, Evotec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR104589
  • RRA-12001, EVT 101/1012 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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