Clinical trial NCT01153347: A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Depression
Keywords: Major Depressive Disorder
MDD
Depression
Safety
add-on therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Targacept Inc.
First posted: 2010-06-30
Enrollment: 2409
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
Secondary outcomes:
measure: 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)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)
timeFrame: Week 16
measure: 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)
timeFrame: Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16
measure: 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)
timeFrame: Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16
measure: Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)
timeFrame: Week 12, Week 14, Week 16
measure: 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
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: 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)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: 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)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in MADRS Total Score From Randomization (Week 8) to Week 9
timeFrame: Randomization (Week 8) to Week 9
measure: Change in MADRS Total Score From Randomization (Week 8) to Week 10
timeFrame: Randomization (Week 8) to Week 10
measure: Change in MADRS Total Score From Randomization (Week 8) to Week 12
timeFrame: Randomization (Week 8) to Week 12
measure: Change in MADRS Total Score From Randomization (Week 8) to Week 14
timeFrame: Randomization (Week 8) to Week 14
measure: Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: 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
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: 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
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: 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
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
measure: Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)
timeFrame: Randomization (Week 8) to end of treatment (Week 16)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Conway
country: United States
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state: Arkansas
city: Little Rock
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city: Arcadia
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state: California
city: Beverly Hills
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city: Garden Grove
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city: Los Angeles
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city: Newport Beach
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city: Oceanside
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city: Pico Rivera
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city: New London
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city: Norwich
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city: Washington
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state: District of Columbia
city: Bradenton
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city: Ft Myers
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city: Ft Walton Beach
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city: Gainsville
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city: Plantation
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city: Joliet
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city: Gaithersburg
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city: Weymouth
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state: Mississippi
city: St. Louis
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city: North Platte
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city: Toms River
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city: Willingboro
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city: Rochester
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city: Staten Island
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city: Sellersvillle
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city: Lincoln
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state: Rhode Island
city: Charleston
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city: Memphis
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city: Austin
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city: Dallas
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city: Irving
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city: San Antonio
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city: Sugar Land
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city: Murray
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city: Bellevue
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state: Washington
city: Bothell
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city: Seattle
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state: Washington
city: South Kirkland
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state: Washington
city: Spokane
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state: Washington
city: Guntur
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Research Site
state: Andhra Pradesh
city: Vishakhapatnam
country: India
facility: Research Site
state: Andhra Pradesh
city: Anand
country: India
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state: Gujarat
city: Junagadh
country: India
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state: Gujarat
city: Vadodara
country: India
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state: Gujarat
city: Rajkot
country: India
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state: Gujrat
city: Bangalore
country: India
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state: Karnataka
city: Aurangabad
country: India
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state: Maharashtra
city: Pune
country: India
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state: Maharashtra
city: Nashik
country: India
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state: Mahara
city: Durham
country: India
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state: NC
city: Chennai
country: India
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state: Tamil Nadu
city: Madurai
country: India
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state: Tamilnadu
city: Lucknow
country: India
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state: Uttar Pradesh
city: Varanasi
country: India
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state: Uttar Prad
city: Kanpur
country: India
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city: Karnataka
country: India
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city: Mysore
country: India
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Hans A. Eriksson, MD,PhD, MBA
role: STUDY_DIRECTOR
affiliation: Florida Clinical Research Center, LLC
name: Andrew J. Cutler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.