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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


, : 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. Journal of Clinical Psychopharmacology 35(1): 77-81

Safety and tolerability are important considerations when selecting patients' treatment for major depressive disorder. We report the long-term safety and tolerability of the nicotinic channel modulator dexmecamylamine (TC-5214), adjunct to selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) in patients with major depressive disorder and who had an inadequate response to antidepressants. This 52-week, double-blind, placebo-controlled study explored the long-term safety and tolerability of dexmecamylamine. Patients were randomized 3:1 to receive flexibly dosed dexmecamylamine 1 to 4 mg adjunct to SSRI/SNRI or placebo plus SSRI/SNRI. The patient population comprised inadequate responders from 2 Phase III acute dexmecamylamine studies (NCT01157078 [study 002], NCT01153347 [study 004]) and de novo patients who responded inadequately during a 6-week open-label antidepressant treatment period preceding randomization. Safety and tolerability were assessed by monitoring adverse events, vital signs, and physical and laboratory parameters. Descriptive statistical analyses were performed on most efficacy-related end points. Sustained efficacy was analyzed using logistic regression. Overall, 813 patients were randomized (610 received dexmecamylamine, 203 received placebo). In total, 82.4% and 84.6% of patients, respectively, experienced an adverse event. Adverse events occurring more frequently with dexmecamylamine vs placebo were constipation (19.6% vs 6.0%), dizziness (12.0% vs 7.0%), and dry mouth (9.7% vs 5.0%). Back pain (2.8% vs 8.5%), weight increase (4.4% vs 7.0%), and fatigue (5.6 % vs 7.5%) occurred more frequently in placebo-treated patients. No notable differences were observed between dexmecamylamine and placebo for any secondary end point. In this long-term study, safety and tolerability of dexmecamylamine were consistent with that reported in acute Phase III studies of dexmecamylamine.

US$19.90

PMID: 25514064

DOI: 10.1097/JCP.0000000000000269


Other references

Dudel, H., 1978: Vergleichende funktionsanatomische Untersuchungen uber die Antennen der Dipteren. 2. Cyclorrhapha (Aschiza und Schizophora - Acalyptratae). Zoologische Jahrbuecher Abteilung fuer Anatomie und Ontogenie der Tiere, 992: 224-298

Cook, R.J.; Dickens, B.M., 2002: Human rights to safe motherhood. Each year an estimated 515000 women die of complications of pregnancy and childbirth, 7 million more suffer serious health problems and 50 million suffer adverse health effects. Over 98% of deaths occur in resource-poor countries. However, poverty...

Adhikari, S.R.; Pradhan, S.N.; Sharma, S.C., 2009: Experiencing stigma: Nepalese perspectives. Experiencing stigma by patients with mental illness in their day to day lives has substantial importance in treatment, compliance and quality of life. There is dearth of information and researches in experiences/ perceptions and coping of stigma i...

Stalin Dhas, T.; Ganesh Kumar, V.; Stanley Abraham, L.; Karthick, V.; Govindaraju, K., 2013: Sargassum myriocystum mediated biosynthesis of gold nanoparticles. Functionalized metal nanoparticles are unique in nature and are being developed for its specificity in drug targeting. In the present study, aqueous extract of Sargassum myriocystum is used for the biosynthesis of gold nanoparticles (AuNPs) by the...

Bindal C.M.; Chittora V.K., 1990: Lithostratigraphy and regional correlation of the Jutogh Formation, Sirmaur District, Himachal Pradesh. Records of the Geological Survey of India 123, Part 8: 209-210

Cuerda, J.; Gracia, F.; Vicens, D., 1991: Dos nuevos yacimientos del Pleistoceno superior marino en Porto Colom (Mallorca). Bolleti de la Societat d'Historia Natural de les Balears. 1989-1990( ); 33: 49-66

Kadnykov, O.H.; Zalyubovs'kyi, I.I.; Kobizs'kyi, V.I.; Vitovtova, T.I., 1978: Magnetic field effects on radical processes in bio membranes. The application of a magnetic field to a biomembrane changes the free radical peroxidation kinetics and tends to modify the viscosity and surface tension of the membrane lipid component. The acceleration of certain redox and radiation-stimulated r...

Preslock, J.P.; Hampton, J.K., 1973: Ornithine decarboxylase stimulation by 3',5'-cyclic AMP in oviduct of Coturnix quail. American Journal of Physiology 225(4): 903-907

Grattagliano, I.; Caraceni, P.; Portincasa, P.; Domenicali, M.; Palmieri, V.O.; Trevisani, F.; Bernardi, M.; Palasciano, G., 2004: Adaptation of subcellular glutathione detoxification system to stress conditions in choline-deficient diet induced rat fatty liver. The response of fatty liver to stress conditions (t-butyl hydroperoxide [t-BH] or 36 h of fasting) was investigated by assessing intracellular glutathione (GSH) compartmentation and redox status, GSH peroxidase (GSH-Px) and reductase (GSSG-Rx) act...

Kottkamp, H.; Hindricks, G.; Chen, X.; Brunn, J.; Willems, S.; Haverkamp, W.; Block, M.; Breithardt, G.; Borggrefe, M., 1995: Radiofrequency catheter ablation of sustained ventricular tachycardia in idiopathic dilated cardiomyopathy. Background: The feasibility of radiofrequency (RF) catheter ablation for the treatment of sustained ventricular tachycardia (VT) in patients with coronary artery disease and remote myocardial infarction has recently been demonstrated. At present,...