A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
NCT ID: NCT01288079
Last Updated: 2012-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
145 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
TC-5214, 1 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
2
TC-5214, 4 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
3
Duloxetine 60 mg Q Day
Duloxetine
Capsule, oral, once daily
4
Placebo
Placebo
Tablet, oral, twice daily for 8 weeks
Interventions
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TC-5214
Tablet, oral, twice daily for 8 weeks
Duloxetine
Capsule, oral, once daily
Placebo
Tablet, oral, twice daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
* Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
* Outpatient status at enrollment and randomization.
Exclusion Criteria
* Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
* Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
* History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
* Pregnancy or lactation.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Hans A Eriksson, MD, PhD, MBA
Role: STUDY_DIRECTOR
AstraZeneca R&D Södertälje
Locations
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Research Site
Beverly Hills, California, United States
Research Site
Chino, California, United States
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Garden Grove, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Bradenton, Florida, United States
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Coral Springs, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Joliet, Illinois, United States
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Prairie Village, Kansas, United States
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Flowood, Mississippi, United States
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New York, New York, United States
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Rochester, New York, United States
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Dayton, Ohio, United States
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Mason, Ohio, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Visakhapatnam, Andh Prad, India
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Ahmedabad, Gujarat, India
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Bangalore, Kamataka, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Nashik, Mahara, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Varanasi, Uttar Prad, India
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Kanpur, , India
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Pune, , India
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Nagoya, Aichi-ken, Japan
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Ichikawa, Chiba, Japan
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Noda, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Sapproro, Hokkaido, Japan
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Akashi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Kawasaki-shi, Kanagawa, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Yatsushiro, Kumamoto, Japan
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Ukyo-ku ,Kyoto, Kyoto, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Kodaira-shi, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Countries
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Other Identifiers
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D4131C00001
Identifier Type: -
Identifier Source: org_study_id