A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

NCT01288079 | Terminated Phase 2 Results

• 1 other identifier: D4131C00001
• Study Type: interventional
• Target: 145
• Locations: 5 countries
• Sites: 63

Brief Summary

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Monotherapy; Inadequate Response to Antidepressant Therapy

Outcome Measures

Primary Outcomes (1)

• Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment

  A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

  Randomization (Week 8) to end of treatment (Week 16)

Study Arms (4)

1

EXPERIMENTAL

TC-5214, 1 mg BID

Drug: TC-5214

2

EXPERIMENTAL

TC-5214, 4 mg BID

Drug: TC-5214

3

ACTIVE COMPARATOR

Duloxetine 60 mg Q Day

Drug: Duloxetine

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TC-5214 DRUG

Tablet, oral, twice daily for 8 weeks

1; 2

Duloxetine DRUG

Capsule, oral, once daily

3

Placebo DRUG

Tablet, oral, twice daily for 8 weeks

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent before initiation of any study-related procedures.
• 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.

You may not qualify if:

• Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (63)

Research Site

Beverly Hills, California, United States

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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

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Shinagawa-ku, Tokyo, Japan

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MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated early and thus only a fraction of the planned number of patients were randomized and many did not complete the study. As a consequence the possibility of interpreting efficacy over an 8 week period is considerably reduced.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Hans A Eriksson, MD, PhD, MBA

  AstraZeneca R&D Södertälje

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 2, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 20, 2012
• Results First Posted: October 29, 2012

Record last verified: 2012-11

Locations

ES (2); IN (11); JP (21); US (25); FI (4)