Safety and Efficacy of EVT 101 in Treatment-Resistant Depression - Full Text View

Sponsor:	Evotec Neurosciences GmbH
Collaborator:	Hoffmann-La Roche
Information provided by (Responsible Party):	Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:	NCT01128452

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.

Condition	Intervention	Phase
Depression	Drug: EVT 101 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Evotec Neurosciences GmbH:

Primary Outcome Measures:

Safety and Tolerability Profile of EVT 101 [ Time Frame: 28 days of EVT 101-Treatment ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Percentage of patients who experience remission [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo	Drug: Placebo HPMC Placebo capsules, once daily for 28 days Other Name: Placebo
Experimental: EVT 101 EVT 101	Drug: EVT 101 HPMC Capsule, 15 mg, once daily for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128452

Locations

United States, California
Evotec Study Site 6
Oceanside, California, United States
Evotec Study Site 19
San Diego, California, United States
Evotec Study Site 16
Santa Ana, California, United States
United States, Florida
Evotec Study Site 11
North Miami, Florida, United States
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 18
Princeton, New Jersey, United States
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, Pennsylvania
Evotec Study Site 17
Allentown, Pennsylvania, United States
United States, Texas
Evotec Study Site 7
Dallas, Texas, United States
Evotec Study Site 12
Houston, Texas, United States
Evotec Study Site 10
San Antonio, Texas, United States

Sponsors and Collaborators

Evotec Neurosciences GmbH

Hoffmann-La Roche

Investigators

Study Director:

Doris Greiling, PhD

Evotec AG

More Information

No publications provided

Responsible Party:	Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:	NCT01128452 History of Changes
Other Study ID Numbers:	EVT 101/1012, IND 104,432
Study First Received:	May 19, 2010
Last Updated:	September 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Evotec Neurosciences GmbH:

Treatment-Resistant Depression

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 21, 2012