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

European Neuropsychopharmacology

Volumn 24, Issue 4, 2014, Pages 564-574

  Vieta, Eduard ^a   Thase, Michael E ^b   Naber, Dieter ^c   D'Souza, Bernadette ^d   Rancans, Elmars ^e   Lepola, Ulla ^f   Olausson, Bengt ^g   Szamosi, Johan ^g   Wilson, Ellis ^h   Hosford, David ⁱ   Dunbar, Geoffrey ⁱ   Tummala, Raj ^h   Eriksson, Hans ^g  

^a INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^d Midwest Clinical Research   (United States)

^e RIGA STRADINS UNIVERSITY   (Latvia)

^f Kuopio Psychiatric Research Clinic   (Finland)

^g ASTRAZENECA R AND D   (Sweden)

^h ASTRAZENECA   (United Kingdom)

ⁱ TARGACEPT INC   (United States)

Author keywords

Adjunct therapy; Major depressive disorder; Nicotinic channel modulator; TC 5214

Indexed keywords

DEXMECAMYLAMINE; PLACEBO; ANTIDEPRESSANT AGENT; MECAMYLAMINE; NICOTINIC RECEPTOR BLOCKING AGENT; SEROTONIN UPTAKE INHIBITOR; CITALOPRAM; DULOXETINE; ESCITALOPRAM; FLUOXETINE; PAROXETINE; SERTRALINE; VENLAFAXINE;

ADULT; AGED; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DRUG EFFICACY; DRUG TOLERABILITY; EUROPE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MIDDLE AGED; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; THERAPY EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; UNITED STATES; ADOLESCENT; ADVERSE EFFECTS; CLINICAL TRIAL; COHORT ANALYSIS; COMBINATION DRUG THERAPY; DEPRESSIVE DISORDER, MAJOR; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DOUBLE BLIND PROCEDURE; DRUG MONITORING; DRUG RESISTANCE; FOLLOW UP; PSYCHOLOGICAL RATING SCALE; YOUNG ADULT; AGITATION; ANTIDEPRESSANT ACTIVITY; ANXIETY; ASTHENIA; ATTENTION DISTURBANCE; DIZZINESS; DRUG RESPONSE; DRUG WITHDRAWAL; HAMILTON DEPRESSION RATING SCALE; HYPOTENSION; NAUSEA; OPEN STUDY; PAIN; PATIENT COMPLIANCE; SEXUAL DYSFUNCTION; SHEEHAN DISABILITY SCALE; SIDE EFFECT; SOMNOLENCE; SUICIDAL IDEATION; TREATMENT OUTCOME; TREMOR; UPPER ABDOMINAL PAIN; UTERUS CANCER; VERTIGO;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; COHORT STUDIES; DEPRESSIVE DISORDER, MAJOR; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DOUBLE-BLIND METHOD; DRUG MONITORING; DRUG RESISTANCE; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; LOST TO FOLLOW-UP; MALE; MECAMYLAMINE; MIDDLE AGED; NICOTINIC ANTAGONISTS; PSYCHIATRIC STATUS RATING SCALES; SEROTONIN UPTAKE INHIBITORS; YOUNG ADULT;

EID: 84895875391     PISSN: 0924977X     EISSN: 18737862     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2013.12.008     Document Type: Article

References (32)

1. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 2000, American Psychiatric Association, Washington, DC, (Text Revision). 4th edition.
2. Barnes T.R. A rating scale for drug-induced akathisia. Br. J. Psychiatry 1989, 154:672-676.
3. Clayton A.H., McGarvey E.L., Clavet G.J. The Changes in Sexual Functioning Questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol. Bull. 1997, 33:731-745.
4. Dunbar G., Hosford D. The potential of the nicotinic channel blocker TC-5214 as augmentation treatment in patients with major depression. Eur. Neuropsychopharmacol. 2010, 20:S334.
5. Dunlop B.W., Thase M.E., Wun C.C., Fayyad R., Guico-Pabia C.J., Musgnung J., Ninan P.T. A meta-analysis of factors impacting detection of antidepressant efficacy in clinical trials: the importance of academic sites. Neuropsychopharmacology 2012, 37:2830-2836.
6. Endicott J., Nee J., Harrison W., Blumenthal R. Quality of life enjoyment and satisfaction questionnaire: a new measure. Psychopharmacol. Bull. 1993, 29:321-326.
7. EuroQol Group EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
8. Guy, W., 1976a. Abnormal Involuntary Movement Scale (AIMS), William Guy (ed), In: ECDEU Assessment Manual for Psychopharmacology - Revised (DHEW Publ. no. ADM 766-338). US Department of Health, Education and Welfare, Public Health Service, Alcohol, Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs, Rockville, MD, pp. 534-537.
9. Guy W. Clinical global impressions. William Guy (ed), In: ECDEU Assessment Manual for Psychopharmacology Publication 1976, 218-222. Department of Health, Education and Welfare, Washington, DC, US.
10. Hamilton M. A rating scale for depression. J. Neurol. Neurosurg. Psychiatry 1960, 23:56-62.
11. Keller M., Montgomery S., Ball W., Morrison M., Snavely D., Liu G., Hargreaves R., Hietala J., Lines C., Beebe K., Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol. Psychiatry 2006, 59:216-223.
12. Knoth R.L., Bolge S.C., Kim E., Tran Q.V. Effect of inadequate response to treatment in patients with depression. Am. J. Manag. Care 2010, 16:e188-e196.
13. Kobak K.A., Leuchter A., DeBrota D., Engelhardt N., Williams J.B., Cook I.A., Leon A.C., Alpert J. Site versus centralized raters in a clinical depression trial: impact on patient selection and placebo response. J. Clin. Psychopharmacol. 2010, 30:193-197.
14. Kramer M.S., Cutler N., Feighner J., Shrivastava R., Carman J., Sramek J.J., Reines S.A., Liu G., Snavely D., Wyatt-Knowles E., Hale J.J., Mills S.G., MacCoss M., Swain C.J., Harrison T., Hill R.G., Hefti F., Scolnick E.M., Cascieri M.A., Chicchi G.G., Sadowski S., Williams A.R., Hewson L., Smith D., Carlson E.J., Hargreaves R.J., Rupniak N.M. Distinct mechanism for antidepressant activity by blockade of central substance P receptors. Science 1998, 281:1640-1645.
15. Lippiello P.M., Beaver J.S., Gatto G.J., James J.W., Jordan K.G., Traina V.M., Xie J., Bencherif M. TC-5214 (S-(+)-mecamylamine): a neuronal nicotinic receptor modulator with antidepressant activity. CNS Neurosci. Ther. 2008, 14:266-277.
16. Mineur Y.S., Picciotto M.R. Nicotine receptors and depression: revisiting and revising the cholinergic hypothesis. Trends Pharmacol. Sci. 2010, 31:580-586.
17. Mitchell A.J. The role of corticotropin releasing factor in depressive illness: a critical review. Neurosci. Biobehav. Rev. 1998, 22:635-651.
18. Montgomery S.A., Åsberg M. A new depression scale designed to be sensitive to change. Br. J. Psychiatry 1979, 134:382-389.
19. Nemeroff C.B. Prevalence and management of treatment-resistant depression. J. Clin. Psychiatry 2007, 68(Suppl. 8):17-25.
20. Perona M.T., Waters S., Hall F.S., Sora I., Lesch K.P., Murphy D.L., Caron M., Uhl G.R. Animal models of depression in dopamine, serotonin, and norepinephrine transporter knockout mice: prominent effects of dopamine transporter deletions. Behav. Pharmacol. 2008, 19:566-574.
21. Perry D.C., Kellar K.J. [3H]epibatidine labels nicotinic receptors in rat brain: an autoradiographic study. J. Pharmacol. Exp. Ther. 1995, 275:1030-1034.
22. Posner, K., Oquendo, M., Stanley, B., Gould, M. (2005) Suicidality Classification Project. http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4065S1_06_FDA-Posner.ppt.
23. Rosenbaum J.F., Fava M., Hoog S.L., Ascroft R.C., Krebs W.B. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol. Psychiatry 1998, 44:77-87.
24. Rush A.J. Limitations in efficacy of antidepressant monotherapy. J. Clin. Psychiatry 2007, 68(Suppl. 10):8-10.
25. Sheehan D.V. Sheehan Disability Scale. In: Handbook of Psychiatric Measures 2000, 113-115. American Psychiatric Association.
26. Sheehan D.V., Lecrubier Y., Sheehan K.H., Amorim P., Janavs J., Weiller E., Hergueta T., Baker R., Dunbar G.C. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J. Clin. Psychiatry 1998, 59(Suppl. 20):22-33.
27. Shytle R.D., Silver A.A., Lukas R.J., Newman M.B., Sheehan D.V., Sanberg P.R. Nicotinic acetylcholine receptors as targets for antidepressants. Mol. Psychiatry 2002, 7:525-535.
28. Trivedi M.H., Corey-Lisle P.K., Guo Z., Lennox R.D., Pikalov A., Kim E. Remission, response without remission, and nonresponse in major depressive disorder: impact on functioning. Int. Clin. Psychopharmacol. 2009, 24:133-138.
29. Undurraga J., Baldessarini R.J. Randomized, placebo-controlled trials of antidepressants for acute major depression: thirty-year meta-analytic review. Neuropsychopharmacology 2012, 37:851-864.
30. Vieta E., Pappadopulos E., Mandel F.S., Lombardo I. Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study. Int. J. Neuropsychopharmacol. 2011, 14:1017-1027.
31. Wade A.G., Haring J A review of the costs associated with depression and treatment noncompliance: the potential benefits of online support. Int. Clin. Psychopharmacol. 2010, 25:288-296.
32. Yildiz A., Vieta E., Tohen M., Baldessarini R.J. Factors modifying drug and placebo responses in randomized trials for bipolar mania. Int. J. Neuropsychopharmacol. 2011, 14:863-875.