NCT01288079

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

Terminated Phase 2 Results posted Last updated 14 November 2012

What this trial tests

Phase 2 trial testing TC-5214 in Major Depressive Disorder in 145 participants. Terminated before completion.

Timeline

1 February 2011

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	145
Start date	1 February 2011
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	63 locations across United States, Estonia, Finland, India, Japan

Drugs / interventions tested

• TC-5214 — full drug profile →
• Duloxetine (duloxetine) — full drug profile →
• Placebo

Conditions studied

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

Sponsor

AstraZeneca — full company profile →

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

1. Duloxetine versus other anti-depressive agents for depression.
   Cipriani A, Koesters M, Furukawa TA, Nosè M, et al · · 2012 · cited 56× · PMID 23076926 · DOI 10.1002/14651858.cd006533.pub2
2. Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.
   Sakurai H, Yonezawa K, Tani H, Mimura M, et al · · 2022 · cited 21× · PMID 35045580 · DOI 10.1055/a-1714-9097