A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01288079
• Other study ID #: D4131C00001
• Status: Terminated
• Phase: Phase 2
• First received: January 26, 2011
• Last updated: November 14, 2012
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineFinland: Finnish Medicines AgencyIndia: Drugs Controller General of IndiaJapan: Pharmaceuticals and Medical Devices AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• TC-5214
Tablet, oral, twice daily for 8 weeks
• Duloxetine
Capsule, oral, once daily
• Placebo
Tablet, oral, twice daily for 8 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  India,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment	A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.	Randomization (Week 8) to end of treatment (Week 16)	No