Expired Study
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Oceanside, California


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.


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


Study is Available At:


Original ID:

CR104589


NCT ID:

NCT01128452


Secondary ID:

RRA-12001, EVT 101/1012


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Janssen Research & Development, LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Patient recruitment


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Doris Greiling, PhD
Study Director
Evotec AG

Study Dates

Start Date:June 2010
Completion Date:March 2011
Completion Type:Actual
Primary Completion Date:March 2011
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 27, 2014
First Received Date:May 19, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentage of patients who experience remission
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients who respond to treatment with study drug
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Efficacy of EVT 101 in depression measured using the MADRS score
Time Frame:28 days
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure:Safety and Tolerability Profile of EVT 101
Time Frame:28 days of EVT 101-Treatment
Safety Issues:True
Description:AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires

Study Interventions

Intervention Type:Drug
Name:EVT 101
Description:HPMC Capsule, 15 mg, once daily for 28 days
Arm Name:EVT 101
Intervention Type:Drug
Name:Placebo
Description:HPMC Placebo capsules, once daily for 28 days
Arm Name:Placebo
Other Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo
Study Arm Type:Experimental
Arm Name:EVT 101
Description:EVT 101

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Janssen Research & Development, LLC
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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