Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-27T13:44:09.549Z Has data issue: false hasContentIssue false
  • English
  • Français

Olanzapine plus carbamazepine v. carbamazepine alone in treating manic episodes

Published online by Cambridge University Press:  02 January 2018

Mauricio Tohen ,
Charles L. Bowden ,
Anatoly B. Smulevich ,
Richard Bergstrom ,
Tonya Quinlan ,
Olawale Osuntokun ,
Wei V. Wang ,
Heather S. Oliff ,
Ferenc Martenyi  and
Ludmila A. Kryzhanovskaya
...Show all authors
Mauricio Tohen*
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana, and McLean Hospital, Harvard Medical School, Belmont, Massachusetts, USA
Charles L. Bowden
Affiliation:
Department of Psychiatry, University of Texas Health Science Center, San Antonio, Texas, USA
Anatoly B. Smulevich
Affiliation:
National Mental Health Research Center, Moscow, Russia
Richard Bergstrom
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana, USA
Tonya Quinlan
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana, USA
Olawale Osuntokun
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana, USA
Wei V. Wang
Affiliation:
Eli Lilly Canada, Danforth, Canada
Heather S. Oliff
Affiliation:
Science Consulting Group, North Tustin, California, USA
Ferenc Martenyi
Affiliation:
Eli Lilly and Company, Area Medical Center, Vienna, Austria
Ludmila A. Kryzhanovskaya
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana, USA
Waldemar Greil
Affiliation:
University of Munich, Germany
*
Dr M. Tohen, Lilly Research Laboratories, Indianapolis, IN 46285, USA. Email: m.tohen@lilly.com
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Background

Combinations of olanzapine and carbamazepine are often used in clinical practice in the management of mania.

Aims

To assess the efficacy and safety of olanzapine plus carbamazepine in mixed and manic bipolar episodes.

Method

Randomised, double-blind, 6-week trial of olanzapine (10–30 mg/day) plus carbamazepine (400–1200 mg/day; n=58) v. placebo plus carbamazepine (n=60) followed by open-label, 20-week olanzapine (10–30 mg/day) plus carbamazepine (400–1200 mg/day, n=86), with change in manic symptoms as main outcome measure. Safety and pharmacokinetics were also evaluated.

Results

There were no significant differences (baseline to endpoint) in efficacy measures between treatment groups, but at 6 weeks triglyceride levels were significantly higher (P=0.008) and potentially clinically significant weight gain (⩾7%) occurred more frequently (24.6% v. 3.4%, P=0.002) in the combined olanzapine and carbamazepine group. Carbamazepine reduced olanzapine concentrations but olanzapine had no effect on carbamazepine concentrations.

Conclusions

The combination of olanzapine and carbamazepine did not have superior efficacy to carbamazepine alone. The increases in weight and triglycerides observed during combination treatment are a matter of concern.

Type
Papers
Information
The British Journal of Psychiatry , Volume 192 , Issue 2 , February 2008 , pp. 135 - 143
Copyright
Copyright © Royal College of Psychiatrists, 2008 

References

1 Tohen, M, Sanger, TM, McElroy, SL, Tollefson, GD, Chengappa, KN, Daniel, DG, Petty, F, Centorrino, F, Wang, R, Grundy, SL, Greaney, MG, Jacobs, TG, David, SR, Toma, V. Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am J Psychiatry 1999; 156: 702–9.Google Scholar
2 Tohen, M, Jacobs, TG, Grundy, SL, McElroy, SL, Banov, MC, Janicak, PG, Sanger, T, Risser, R, Zhang, F, Toma, V, Francis, J, Tollefson, GD, Breier, A. Efficacy of olanzapine in acute bipolar mania. A double-blind, placebo-controlled study. Arch Gen Psychiatry 2000; 57: 841–9.CrossRefGoogle Scholar
3 Weisler, RH, Keck, PE Jr, Swann, AC, Cutler, AJ, Ketter, TA, Kalali, AH on behalf of the SPD417 Study Group. Extended-release carbamazepine capsules as monotherapy for acute mania in bipolar disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2005; 66: 323–30.Google Scholar
4 Weisler, RH, Kalali, AH, Ketter, TA on behalf of the SPD417 Study Group. A multicenter, randomized, double-blind, placebo-controlled trial of extended-release carbamazepine capsules as monotherapy for bipolar disorder patients with manic or mixed episodes. J Clin Psychiatry 2004; 65: 478–84.Google Scholar
5 Zarate, CA, Tohen, M. Carbamazapine. In Comprehensive Textbook of Psychiatry (eds Sadock, BJ, Sadock, VA): 2282–8. Lippincott, Williams and Wilkins, 1999.Google Scholar
6 Goodwin, GM. Evidence-based guidelines for treating bipolar disorder: recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2003; 17: 149–73.Google Scholar
7 Licht, RW, Vestergaard, P, Kessing, LV, Larsen, JK, Thomsen, PH on behalf of the Danish Psychiatric Association and the Child and Adolescent Psychiatric Association in Denmark. Psychopharmacological treatment with lithium and antiepileptic drugs: suggested guidelines from the Danish Psychiatric Association and the Child and Adolescent Psychiatric Association in Denmark. Acta Psychiatr Scand Suppl 2003; 419: 1–22.Google Scholar
8 Vestergaard, P. Guidelines for maintenance treatment of bipolar disorder: are there discrepancies between European and North American recommendations? Bipolar Disord 2004; 6: 519–22.Google Scholar
9 Lucas, RA, Gilfillan, DJ, Bergstrom, RF. A pharmacokinetic interaction between carbamazepine and olanzapine: observations on possible mechanism. Eur J Clin Pharmacol 1998; 54: 639–43.Google Scholar
10 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (4th edn) (DSM–IV). APA, 2000.Google Scholar
11 First, MBB, Spitzer, RL, Williams, JB. Structured Clinical Interview for DSM–IV AXIS I Disorders (Clinical Version) SCID–I Administration Booklet. American Psychiatric Publishing, 1997.Google Scholar
12 Young, RC, Biggs, JT, Ziegler, VE, Meyer, DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429–35.Google Scholar
13 Montgomery, SA, Åsberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382–9.Google Scholar
14 Spearing, MK, Post, RM, Leverich, GS, Brandt, D, Nolen, W. Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI–BP. Psychiatry Res 1997; 73: 159–71.CrossRefGoogle Scholar
15 Simpson, GM, Angus, JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 1970; 212: 11–19.Google Scholar
16 Barnes, TR. A rating scale for drug-induced akathisia. Br J Psychiatry 1989; 154: 672–6.CrossRefGoogle ScholarPubMed
17 Guy, W. ECDEU Assessment Manual for Psychopharmacology, Revised. US Department of Health, Education and Welfare, 1976.Google Scholar
18 National Cholesterol Education Program Expert Panel. Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Heart, Lung, and Blood Institute, National Institutes of Health, 2002. NIH Publication number: 02–5215.Google Scholar
19 American Diabetes Association. Position statements and American Diabetes Association statements. Diabetes Care 2006; 29 (suppl 1): S75–7.Google Scholar
20 Gex-Fabry, M, Balant-Gorgia, AE, Balant, LP. Therapeutic drug monitoring of olanzapine: the combined effect of age, gender, smoking, and comedication. Ther Drug Monit 2003; 25: 46–53.CrossRefGoogle ScholarPubMed
21 Skogh, E, Reis, M, Dahl, ML, Lundmark, J, Bengtsson, F. Therapeutic drug monitoring data on olanzapine and its N-demethyl metabolite in the naturalistic clinical setting. Ther Drug Monit 2002; 24: 518–26.CrossRefGoogle ScholarPubMed
22 Tegretol package insert. http://www.pharma.us.novartis.com/product/pi/pdf/tegretol.pdf. Novartis Pharmaceutical Corporation, 2003.Google Scholar
23 Hennen, J, Perlis, RH, Sachs, G, Tohen, M, Baldessarini, RJ. Weight gain during treatment of bipolar I patients with olanzapine. J Clin Psychiatry 2004; 65: 1679–87.Google Scholar
24 Tohen, M, Ketter, TA, Zarate, CA, Suppes, T, Frye, M, Altshuler, L, Zajecka, J, Schuh, LM, Risser, RC, Brown, E, Baker, RW. Olanzapine versus divalproex sodium for the treatment of acute mania and maintenance of remission: a 47-week study. Am J Psychiatry 2003; 160: 1263–71.Google Scholar
25 Weisler, RH, Hirschfeld, R, Cutler, AJ, Gazda, T, Ketter, TA, Keck, PE, Swann, A, Kalali, A on behalf of the SPD417 Study Group. Extended-release carbamazepine capsules as monotherapy in bipolar disorder: pooled results from two randomised, double-blind, placebo-controlled trials. CNS Drugs 2006; 20: 219–31.Google Scholar
26 Breier, A, Berg, PH, Thakore, JH, Naber, D, Gattaz, WF, Cavazzoni, P, Walker, DJ, Roychowdhury, SM, Kane, JM. Olanzapine versus ziprasidone: results of a 28-week double-blind study in patients with schizophrenia. Am J Psychiatry 2005; 162: 1879–87.Google Scholar
27 Ketter, TA, Kalali, AH, Weisler, RH on behalf of the SPD417 Study Group. A 6-month, multicenter, open-label evaluation of beaded, extended-release carbamazepine capsule monotherapy in bipolar disorder patients with manic or mixed episodes. J Clin Psychiatry 2004; 65: 668–73.Google Scholar
28 Zyprexa package insert. http://pi.lilly.com/us/zyprexa-pi.pdf. Eli Lilly Corporation, 2006.Google Scholar
29 Bowden, CL, Calabrese, JR, McElroy, SL, Gyulai, L, Wassef, A, Petty, F, Pope, HG Jr, Chou, JC, Keck, PE Jr, Rhodes, LJ, Swann, AC, Hirschfeld, RM, Wozniak, PJ. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Arch Gen Psychiatry 2000; 57: 481–9.Google Scholar
30 Yatham, LN, Vieta, E, Young, AH, Möller, HJ, Paulsson, B, Vågerö, M. A double blind, randomized, placebo-controlled trial of quetiapine as an add-on therapy to lithium or divalproex for the treatment of bipolar mania. Int Clin Psychopharmacol 2007; 22: 212–20.Google Scholar
31 Vieta, E, Carné, X. The use of placebo in clinical trials on bipolar disorder: a new approach for an old debate. Psychother Psychosom 2005; 74: 10–16.Google Scholar
32 Yatham, LN, Grossman, F, Augustyns, I, Vieta, E, Ravindran, A. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. Br J Psychiatry 2003; 182: 141–7.Google Scholar
Supplementary material: PDF

Tohen et al. supplementary material

Supplementary Table S1-S3

Download Tohen et al. supplementary material(PDF)
PDF 40.3 KB
Supplementary material: File

Tohen et al. supplementary material

Supplementary Material

Download Tohen et al. supplementary material(File)
File 473 Bytes
Submit a response

eLetters

No eLetters have been published for this article.