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Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT01128452
Collaborator
Hoffmann-La Roche (Industry)
8
Enrollment
14
Locations
2
Arms
9
Duration (Months)
0.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: EVT 101
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jun 1, 2010
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability Profile of EVT 101 [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 [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 [4 weeks]

  3. Percentage of patients who experience remission [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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

Contacts and Locations

Locations

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01128452
Other Study ID Numbers:
  • CR104589
  • RRA-12001, EVT 101/1012
First Posted:
May 21, 2010
Last Update Posted:
Mar 28, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Janssen Research & Development, LLC
Treatment-Resistant Depression
Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant

Study Results

No Results Posted as of Mar 28, 2016