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Cited by 45Treatment of Major DepressionTryptophan and brain disordersBipolar Disorder and Treatment

Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant

Vieta, Eduard, Thase, Michael E., Naber, Dieter, D’Souza, Bernadette, Rancans, Elmars, Lepola, Ulla, Olausson, Bengt, Szamosi, Johan +5 more·2014·European Neuropsychopharmacology
DOI 10.1016/j.euroneuro.2013.12.008
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Abstract

This paper reports the efficacy and tolerability of the nicotinic channel modulator TC-5214 (dexmecamylamine) as adjunct therapy for patients with major depressive disorder who have an inadequate response to initial antidepressant treatment in 2 Phase III studies. These double-blind, placebo-controlled studies (NCT01157078, D4130C00002 [Study 002] conducted in the US and India; NCT01180400, D4130C00003 [Study 003] conducted in Europe) comprised 8 weeks of open-label antidepressant treatment followed by 8 weeks of active treatment during which patients were randomized to flexibly-dosed TC-5214 1-4 mg twice daily (BID) or placebo as an adjunct to ongoing therapy with SSRI/SNRI. The primary efficacy endpoint in both studies was change in Montgomery Åsberg Depression Rating Scale (MADRS) total score from randomization (week 8) to treatment end (week 16). Secondary endpoints included change in Sheehan Disability Scale and Hamilton Depression Rating Scale 17-item scores. Study 002 randomized 319 patients and Study 003 randomized 295 patients to TC-5214 or placebo. At treatment end, no significant differences were seen for change in MADRS total score with TC-5214 versus placebo. Furthermore, there were no significant differences in any of the secondary endpoints. The most commonly reported (≥ 10%) adverse events with TC-5214 in these studies were constipation and headache. In these 2 flexibly-dosed studies, no specific therapeutic effects were observed for TC-5214 (1-4 mg BID) adjunct to antidepressant in the primary endpoint or any secondary endpoint; however, TC-5214 was generally well tolerated. In conclusion, no antidepressant effect of TC-5214 was observed in these studies.

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Authors
Vieta, E., Thase, M. E., Naber, D., D’Souza, B., Rancans, E., Lepola, U., Olausson, B., Szamosi, J., Wilson, E., Hosford, D., Dunbar, G., Tummala, R., & Eriksson, H.
Affiliations
  • Centro de Investigación Biomédica en Red de Salud Mental (ES)
  • University of Pennsylvania (US)
  • University Medical Center Hamburg-Eppendorf (DE)
  • Kuopio University Hospital (FI)
  • AstraZeneca (Sweden) (SE)
  • AstraZeneca (United States) (US)
Corresponding author
Vieta, Eduard
ORCID
Venue
European Neuropsychopharmacology
Publisher
Elsevier BV
Published
2014-04
Volume
24
Issue
4
Pages
564-574
ISSN
0924-977X (ISSN-L)
DOI
10.1016/j.euroneuro.2013.12.008
OpenAlex
W1984036736
Cited by
43
References
31
Citations by year
2026: 2 · 2025: 1 · 2024: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 2 · 2018: 5 · 2017: 4 · 2016: 6 · 2015: 10 · 2014: 4
FWCI
5.14
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • European Neuropsychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Funders
AstraZeneca Pharmaceuticals in co-development with Targacept, Inc., and registered at ClinicalTrials.gov (NCT01157078, NCT01180400)
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Keywords
major depressive disorder, adjunctive therapy, flexible dosing, inadequate response to antidepressants, antidepressant efficacy, tolerability, constipation, headache
MeSH terms
Adolescent, Adult, Aged, Antidepressive Agents, Major Depressive Disorder, Double-Blind Method, Drug Resistance, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Mecamylamine, Middle Aged, Psychiatric Status Rating Scales, Cohort Studies, Drug Monitoring, Selective Serotonin Reuptake Inhibitors, Nicotinic Antagonists, Diagnostic and Statistical Manual of Mental Disorders, Young Adult, Lost to Follow-Up

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