NCT01157078

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 With 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 319 participants. Completed in 1 November 2011.

Timeline

1 June 2010

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	319
Start date	1 June 2010
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	51 locations across United States, India

Drugs / interventions tested

• TC-5214 — full drug profile →
• Placebo

Conditions studied

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

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or Depression. 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.

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
  Time frame: Randomization (Week 8) to end of treatment (Week 16)
  A 10-item scale for the evaluation of depressive symptoms. Each 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.

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 together with another antidepressant.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant.
   Vieta E, Thase ME, Naber D, D'Souza B, et al · · 2014 · cited 31× · PMID 24507016 · DOI 10.1016/j.euroneuro.2013.12.008
2. 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
3. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study.
   Tummala R, Desai D, Szamosi J, Wilson E, et al · · 2015 · cited 6× · PMID 25514064 · DOI 10.1097/jcp.0000000000000269