NCT01152554

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study 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

Completed Phase 3 Results posted Last updated 14 March 2014

What this trial tests

Phase 3 trial testing TC-5214 in Major Depressive Disorder in 813 participants. Completed in 1 February 2012.

Timeline

1 June 2010

Primary endpoint
1 February 2012

1 February 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	813
Start date	1 June 2010
Primary completion	1 February 2012
Estimated completion	1 February 2012
Sites	94 locations across United States, Puerto Rico

Drugs / interventions tested

• TC-5214 — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• MDD — all drugs for MDD →
• Depression — all drugs for Depression →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or MDD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Frequency of Patients Experiencing at Least One Adverse Event (AE)
  Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
  The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
• Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
  Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
  The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
• Frequency of Patients Experiencing Serious Adverse Events (SAEs)
  Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
  The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.

Sponsor's own description

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 for 52 weeks with another antidepressant medicine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Functioning outcomes with adjunctive treatments for major depressive disorder: a systematic review of randomized placebo-controlled studies.
   Weiller E, Weiss C, Watling CP, Edge C, et al · · 2018 · cited 12× · PMID 29343962 · DOI 10.2147/ndt.s146840