A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

NCT01153347 | Completed Phase 3 Results

• 1 other identifier: D4130C00004
• Study Type: interventional
• Target: 2,409
• Locations: 3 countries
• Sites: 99

Brief Summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Conditions

Major Depressive Disorder; Depression

Keywords

Major Depressive Disorder; MDD; Depression; Safety; add-on 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 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)

Secondary Outcomes (22)

• Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

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

• Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

  Week 16

• Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)

  Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16

• Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

  Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16

• Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

  Week 12, Week 14, Week 16

Study Arms (4)

SSRI/Serotonin/SNRI+ TC-5214 0.5 mg

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID

Drug: TC-5214

SSRI/Serotonin/SNRI + TC-5214 2 mg

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID

Drug: TC-5214

SSRI/Serotonin/SNRI + TC-5214 4 mg

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID

Drug: TC-5214

SSRI/Serotonin/SNRI + Placebo

PLACEBO COMPARATOR

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Drug: Placebo

Interventions

TC-5214 DRUG

Tablet, oral, twice daily for 8 weeks

SSRI/Serotonin/SNRI + TC-5214 2 mg; SSRI/Serotonin/SNRI + TC-5214 4 mg; SSRI/Serotonin/SNRI+ TC-5214 0.5 mg

Placebo DRUG

Tablet, oral, twice daily for 8 weeks

SSRI/Serotonin/SNRI + Placebo

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.
• 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.
• History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Sponsors & Collaborators

• AstraZeneca: lead
• Targacept Inc.: collaborator

Study Sites (99)

Research Site

Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Conway, Arkansas, United States

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Little Rock, Arkansas, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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Garden Grove, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Pico Rivera, California, United States

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Santa Ana, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Cromwell, Connecticut, United States

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New London, Connecticut, United States

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Norwich, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Fort Myers, Florida, United States

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Fort Walton Beach, Florida, United States

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Gainsville, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, 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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Roswell, Georgia, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Schaumburg, Illinois, United States

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Skokie, Illinois, United States

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Valparaiso, Indiana, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Florence, Kentucky, United States

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Baltimore, Maryland, United States

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Gaithersburg, Maryland, United States

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Boston, Massachusetts, United States

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Weymouth, Massachusetts, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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North Platte, Nebraska, United States

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Toms River, New Jersey, United States

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Willingboro, New Jersey, United States

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Mount Kisco, New York, 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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Staten Island, New York, United States

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Avon Lake, Ohio, United States

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Beachwood, Ohio, United States

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Beechwood, Ohio, United States

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Cincinnati, Ohio, United States

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Mason, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersvillle, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Murray, Utah, United States

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Bellevue, Washington, United States

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Bothell, Washington, United States

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Seattle, Washington, United States

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South Kirkland, Washington, United States

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Spokane, Washington, United States

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Guntur, Andhra Pradesh, India

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Vijayawada, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Anand, Gujarat, India

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Jūnāgadh, Gujarat, India

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Rajkot, Gujarat, India

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Vadodara, Gujarat, India

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Bangalore, Karnataka, India

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Aurangabad, Maharashtra, India

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Pune, Maharashtra, India

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Nashik, Mahara, India

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Durham, NC, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Lucknow, Uttar Pradesh, India

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Varanasi, Uttar Prad, India

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Kanpur, India

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Karnataka, India

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Mysore, India

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San Juan, Puerto Rico

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Related Publications (1)

• Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

  PMID: 25602163 DERIVED

Related Links

• CSR-D4130C00004.pdf
• D4130C00004/Clinical Study Protocol

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Hans A. Eriksson, MD,PhD, MBA

  AstraZeneca

  STUDY DIRECTOR

• Andrew J. Cutler, MD

  Florida Clinical Research Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 11, 2014
• Results First Posted: November 20, 2012

Record last verified: 2014-03

Locations

US (79); IN (19); PR (1)