Clinical trial NCT01180400: 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 TC-5214 (S-mecamylamine) in Flexible Doses 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: 2010-08-12
Enrollment: 295
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.

Detailed description: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

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.
* Out-patient 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 the investigational product in this patient population

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 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)
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Site
city: Kutna Hora
country: Czech Republic
facility: Research Site
city: Litomerice
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 10 - Strasnice
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Praha 8
country: Czech Republic
facility: Research Site
city: Praha 9
country: Czech Republic
facility: Research Site
city: Dublin
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tallin
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Voru
country: Estonia
facility: Research Site
city: Dublin
country: Finland
facility: Research Site
city: Espoo
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Toulon
country: France
facility: Research Site
state: La Seyne Sur Mer
city: Douai
country: France
facility: Research Site
city: Dublin
country: France
facility: Research Site
city: Elancourt
country: France
facility: Research Site
city: Jarnac
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Nimes Cedex 9
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
state: Rp
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dublin
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Dublin
country: Hungary
facility: Research Site
city: Dublin
country: Latvia
facility: Research Site
city: Jelgava
country: Latvia
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Sigulda
country: Latvia
facility: Research Site
city: Strenci
country: Latvia
facility: Research Site
city: Ziegzdrai
country: Lithuania
facility: Research Site
state: Kaunas
city: Dublin
country: Lithuania
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Palanga
country: Lithuania
facility: Research Site
city: Silute
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Belchatow
country: Poland
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszczy
country: Poland
facility: Research Site
city: Dublin
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Leszno
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Sosnowiec
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Toru
country: Poland
facility: Research Site
city: Zuromin
country: Poland
facility: Research Site
city: Dublin
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D
name: Hans A. Eriksson, MD, Ph.D, MBA
role: STUDY_DIRECTOR
affiliation: University Hospital Hamburg
name: D. Naber, Professor Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.