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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Depression

Intervention: TC-5214 (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Hans A. Eriksson, MD,PhD, MBA, Study Director, Affiliation: AstraZeneca
Andrew J. Cutler, MD, Principal Investigator, Affiliation: Florida Clinical Research Center, LLC

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III,Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.

Secondary outcome:

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)

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

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)

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

Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score

Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)

Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16)

Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

Change in MADRS Total Score From Randomization (Week 8) to Week 9

Change in MADRS Total Score From Randomization (Week 8) to Week 10

Change in MADRS Total Score From Randomization (Week 8) to Week 12

Change in MADRS Total Score From Randomization (Week 8) to Week 14

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score

Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16

Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)

Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Research Site, Kanpur, India

Research Site, Karnataka, India

Research Site, Mysore, India

Research Site, San Juan, Puerto Rico

Research Site, Birmingham, Alabama, United States

Research Site, Guntur, Andhra Pradesh, India

Research Site, Vijayawada, Andhra Pradesh, India

Research Site, Vishakhapatnam, Andhra Pradesh, India

Research Site, Tucson, Arizona, United States

Research Site, Conway, Arkansas, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Arcadia, California, United States

Research Site, Beverly Hills, California, United States

Research Site, Garden Grove, California, United States

Research Site, Los Angeles, California, United States

Research Site, Newport Beach, California, United States

Research Site, Oakland, California, United States

Research Site, Oceanside, California, United States

Research Site, Pico Rivera, California, United States

Research Site, Santa Ana, California, United States

Research Site, Upland, California, United States

Research Site, Denver, Colorado, United States

Research Site, Cromwell, Connecticut, United States

Research Site, New London, Connecticut, United States

Research Site, Norwich, Connecticut, United States

Research Site, Washington, District of Columbia, United States

Research Site, Bradenton, Florida, United States

Research Site, Ft Myers, Florida, United States

Research Site, Ft Walton Beach, Florida, United States

Research Site, Gainsville, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, North Miami, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Plantation, Florida, United States

Research Site, South Miami, Florida, United States

Research Site, St Petersburg, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Roswell, Georgia, United States

Research Site, Anand, Gujarat, India

Research Site, Junagadh, Gujarat, India

Research Site, Vadodara, Gujarat, India

Research Site, Rajkot, Gujrat, India

Research Site, Hoffman Estates, Illinois, United States

Research Site, Joliet, Illinois, United States

Research Site, Schaumburg, Illinois, United States

Research Site, Skokie, Illinois, United States

Research Site, Valparaiso, Indiana, United States

Research Site, Prairie Village, Kansas, United States

Research Site, Wichita, Kansas, United States

Research Site, Bangalore, Karnataka, India

Research Site, Florence, Kentucky, United States

Research Site, Nashik, Mahara, India

Research Site, Aurangabad, Maharashtra, India

Research Site, Pune, Maharashtra, India

Research Site, Baltimore, Maryland, United States

Research Site, Gaithersburg, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Weymouth, Massachusetts, United States

Research Site, Flowood, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Durham, NC, India

Research Site, North Platte, Nebraska, United States

Research Site, Toms River, New Jersey, United States

Research Site, Willingboro, New Jersey, United States

Research Site, Mount Kisco, New York, United States

Research Site, New York, New York, United States

Research Site, Rochester, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Avon Lake, Ohio, United States

Research Site, Beachwood, Ohio, United States

Research Site, Beechwood, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Mason, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Norristown, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Sellersvillle, Pennsylvania, United States

Research Site, Lincoln, Rhode Island, United States

Research Site, Charleston, South Carolina, United States

Research Site, Chennai, Tamil Nadu, India

Research Site, Madurai, Tamilnadu, India

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Irving, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Sugar Land, Texas, United States

Research Site, Murray, Utah, United States

Research Site, Varanasi, Uttar Prad, India

Research Site, Lucknow, Uttar Pradesh, India

Research Site, Bellevue, Washington, United States

Research Site, Bothell, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, South Kirkland, Washington, United States

Research Site, Spokane, Washington, United States

Additional Information

CSR-D4130C00004.pdf

D4130C00004/Clinical Study Protocol

Starting date: June 2010
Last updated: March 14, 2014

Page last updated: August 23, 2015

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