Clinical trial NCT01288079: A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Monotherapy
Inadequate Response to Antidepressant Therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 145
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 assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.


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.
* Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
* 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.
* Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
* History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
* Pregnancy or lactation.

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:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Chino
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Coral Springs
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: St Petersburg
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Mason
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Tallinn
country: Estonia
facility: Research Site
city: Tallin
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Jyväskylä
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Visakhapatnam
country: India
facility: Research Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Kamataka
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Nashik
country: India
facility: Research Site
state: Mahara
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Varanasi
country: India
facility: Research Site
state: Uttar Prad
city: Kanpur
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Ichikawa
country: Japan
facility: Research Site
state: Chiba
city: Noda City
country: Japan
facility: Research Site
state: Chiba
city: Fukuoka-city
country: Japan
facility: Research Site
state: Fukuoka
city: Omuta-City
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Sapproro
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yatsushiro-city
country: Japan
facility: Research Site
state: Kumamoto
city: Yatsushiro
country: Japan
facility: Research Site
state: Kumamoto
city: Ukyo-ku ,Kyoto
country: Japan
facility: Research Site
state: Kyoto
city: Kurashiki-shi
country: Japan
facility: Research Site
state: Okayama
city: Kodaira-shi
country: Japan
facility: Research Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kumamoto
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Hans A Eriksson, MD, PhD, MBA
role: STUDY_DIRECTOR
References: