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

NCT01152554 | Completed Phase 3 Results

• 1 other identifier: D4130C00007
• Study Type: interventional
• Target: 813
• Locations: 2 countries
• Sites: 94

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 for 52 weeks with another antidepressant medicine.

Conditions

Major Depressive Disorder; MDD; Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Frequency of Patients Experiencing at Least One Adverse Event (AE)

  The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.

  Randomization (Week 0) to end of the follow-up period (Week 54)

• Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)

  The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.

  Randomization (Week 0) to end of the follow-up period (Week 54)

• Frequency of Patients Experiencing Serious Adverse Events (SAEs)

  The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.

  Randomization (Week 0) to end of the follow-up period (Week 54)

Secondary Outcomes (6)

• Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24

  Week 12 to Week 24

• Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52

  Week 12 to Week 52

• Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)

  Randomization (Week 0) to end of treatment (Week 52)

• Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score

  Randomization (Week 0) to end of treatment (Week 52)

• Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score

  Randomization (Week 0) to end of treatment (Week 52)

Study Arms (2)

SSRI/Serotonin/SNRI + TC-5214 1-4 mg

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 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 52 weeks

SSRI/Serotonin/SNRI + TC-5214 1-4 mg

Placebo DRUG

Tablet, oral, twice daily for 52 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.
• Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.

Sponsors & Collaborators

• AstraZeneca: lead
• Targacept Inc.: collaborator

Study Sites (94)

Research Site

Birmingham, Alabama, United States

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Tuscaloosa, Alabama, United States

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Tucson, Arizona, 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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Carson, California, United States

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Cerritos, California, United States

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Chino, California, United States

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Costa Mesa, California, United States

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Encino, California, United States

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Escondido, California, United States

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Garden Grove, California, United States

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Irvine, California, United States

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Los Alamitos, 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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Pico Rivera, California, United States

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Riverside, California, United States

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Sherman Oaks, California, United States

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Torrance, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Norwalk, Connecticut, United States

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Norwich, Connecticut, United States

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Bradenton, Florida, United States

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Coral Springs, Florida, United States

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Fort Myers, Florida, United States

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Gainsville, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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North Miami, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Pinecrest, Florida, United States

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Plantation, 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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Roswell, Georgia, United States

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Chicago, Illinois, 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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Lafayette, Indiana, 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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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Gaithersburg, Maryland, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Weymouth, Massachusetts, United States

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Flowood, Mississippi, United States

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Creve Coeur, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, 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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Albuquerque, New Mexico, United States

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Fresh Meadows, New York, 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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Charlotte, North Carolina, United States

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Wilmington, North Carolina, United States

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Beechwood, Ohio, United States

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Canton, Ohio, United States

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Dayton, Ohio, United States

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Dublin, Ohio, United States

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Mason, Ohio, United States

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Middleburg Heights, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Friendswood, Texas, United States

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Irving, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Woodstock, Vermont, United States

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Seattle, Washington, United States

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South Kirkland, Washington, United States

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Middleton, Wisconsin, United States

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San Juan, Puerto Rico

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Related Publications (1)

• Tummala R, Desai D, Szamosi J, Wilson E, Hosford D, Dunbar G, Eriksson H. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. J Clin Psychopharmacol. 2015 Feb;35(1):77-81. doi: 10.1097/JCP.0000000000000269.

  PMID: 25514064 DERIVED

Related Links

• CSR-D4130C00007.pdf
• D4130C00007/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, Ph.D, 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 28, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 11, 2014
• Results First Posted: October 29, 2012

Record last verified: 2014-03

Locations

PR (1); US (93)