Treatment-resistant bipolar depression: A STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone

American Journal of Psychiatry

Volumn 163, Issue 2, 2006, Pages 210-216

  Nierenberg, Andrew A ^a   Ostacher, Michael J ^b   Calabrese, Joseph R ^b   Ketter, Terence A ^b   Marangell, Lauren B ^b   Miklowitz, David J ^b   Miyahara, Sachiko ^b   Bauer, Mark S ^b   Thase, Michael E ^b   Wisniewski, Stephen R ^b   Sachs, Gary S ^b  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; CARBAMAZEPINE; FLUOXETINE; INOSITOL; LAMOTRIGINE; LITHIUM; MONOAMINE OXIDASE INHIBITOR; MOOD STABILIZER; OLANZAPINE; PRAMIPEXOLE; QUETIAPINE; RILUZOLE; RISPERIDONE; TRANQUILIZER; TRAZODONE; TRICYCLIC ANTIDEPRESSANT AGENT; VALPROIC ACID; ANTICONVULSIVE AGENT; NEUROLEPTIC AGENT; TRIAZINE DERIVATIVE; VITAMIN B COMPLEX;

ADULT; ARTICLE; BIPOLAR DEPRESSION; BIPOLAR I DISORDER; BIPOLAR II DISORDER; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED MEDICINE; HUMAN; MAJOR CLINICAL STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; BIPOLAR DISORDER; COMPARATIVE STUDY; DRUG ADMINISTRATION; DRUG COMBINATION; FEMALE; MAJOR DEPRESSION; MALE; MIDDLE AGED; MULTICENTER STUDY; PSYCHOLOGICAL ASPECT; PSYCHOLOGICAL RATING SCALE;

ADULT; ANTICONVULSANTS; ANTIDEPRESSIVE AGENTS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; DEPRESSIVE DISORDER, MAJOR; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INOSITOL; MALE; MIDDLE AGED; PSYCHIATRIC STATUS RATING SCALES; RISPERIDONE; TREATMENT OUTCOME; TRIAZINES; VITAMIN B COMPLEX;

EID: 33645005906     PISSN: 0002953X     EISSN: None     Source Type: Journal    
DOI: 10.1176/appi.ajp.163.2.210     Document Type: Article

References (38)

1. Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, Leon AC, Rice JA, Keller MB: The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 2002; 59:530-537
2. Judd LL, Akiskal HS, Schettler PJ, Coryell W, Endicott J, Maser JD, Solomon DA, Leon AC, Keller MB: A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry 2003; 60:261-269
3. Altshuler LL, Gitlin MJ, Mintz J, Leight KL, Frye MA: Subsyndromal depression is associated with functional impairment in patients with bipolar disorder. J Clin Psychiatry 2002; 63:807-811
4. Post RM, Denicoff KD, Leverich GS, Altshuler LL, Frye MA, Suppes TM, Rush AJ, Keck PE, McElroy SL, Luckenbaugh DA, Pollio C, Kupka M, Nolen WA: Morbidity in 258 bipolar outpatients followed for 1 year with daily prospective ratings on the NIMH Life Chart Method. J Clin Psychiatry 2003; 64:680-690
5. Post RM, Leverich GS, Nolen WA, Kupka RW, Altshuler LL, Frye MA, Suppes T, McElroy S, Keck P, Grunze H, Walden J: A re-evaluation of the role of antidepressants in the treatment of bipolar depression: data from the Stanley Foundation Bipolar Network. Bipolar Disord 2003; 5:396-406
6. Joffe RT, MacQueen GM, Marriott M, Young TL: A prospective, longitudinal study of percentage of time spent ill in patients with bipolar I or bipolar II disorders. Bipolar Disord 2004; 6:61-66
7. American Psychiatric Association: Practice Guideline for the Treatment of Patients With Bipolar Disorder (Revision). Am J Psychiatry 2002; 159(April suppl)
8. Goodwin GM (Consensus Group of the British Association for Psychopharmacology): Evidence-based guidelines for treating bipolar disorder: recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2003; 2:149-173
9. Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines Team for Bipolar Disorder: Australian and New Zealand clinical practice guidelines for the treatment of bipolar disorder. Aust NZ J Psychiatry 2004; 38:280-305
10. Calabrese JR, Kasper S, Johnson G, Tajima O, Vieta E, Yatham LN, Young AH: International Consensus Group on Bipolar I Depression Treatment Guidelines. J Clin Psychiatry 2004; 65:571-579
11. Suppes T, Dennehy EB, Hirschfeld RM, Altshuler LL, Bowden CL, Calabrese JR, Crismon ML, Ketter TA, Sachs GS, Swann AC: The Texas Implementation of Medication Algorithms: update to the algorithms for treatment of bipolar I disorder. J Clin Psychiatry 2005; 66:870-886
12. Gijsman HJ, Geddes JR, Rendell JM, Nolen WA, Goodwin GM: Antidepressants for bipolar depression: a systematic review of randomized, controlled trials. Am J Psychiatry 2004; 161:1537-1547
13. Kraemer HC, Gardner C, Brooks JO, Yesavage JA: Advantages of excluding underpowered studies in meta-analysis: inclusionist versus exclusionist viewpoints. Psychol Methods 1998; 3:23-31
14. Prien RF, Klett CJ, Caffey EM: Lithium carbonate and imipramine in prevention of affective episodes: a comparison in recurrent affective illness. Arch Gen Psychiatry 1973; 29:420-425
15. Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD: Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry 2001; 158:906-912
16. Yatham LN, Kennedy SH, O'Donovan C, Parikh S, MacQueen G, McIntyre R, Sharma V, Silverstone P, Alda M, Baruch P, Beaulieu S, Daigneault A, Milev R, Young LT, Ravindran A, Schaffer A, Connolly M, Gorman CP: Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: consensus and controversies. Bipolar Disord 2005; 3(suppl 7):5-69
17. Homan S, Lachenbruch PA, Winkur G, Clayton P: An efficacy study of electroconvulsive therapy and antidepressants in the treatment of primary depression. Psychol Med 1982; 12:615-624
18. Himmelhoch JM, Thase ME, Mallinger AG, Houck P: Tranylcypromine versus imipramine in anergic bipolar depression. Am J Psychiatry 1991; 148:910-916
19. Thase ME, Mallinger AG, McKnight D, Himmelhoch JM: Treatment of imipramine-resistant recurrent depression, IV: a double-blind crossover study of tranylcypromine for anergic bipolar depression. Am J Psychiatry 1992; 149:195-198
20. Young LT, Joffe RT, Robb JC, MacQueen GM, Marriott M, Patelis-Siotis I: Double-blind comparison of addition of a second mood stabilizer versus an antidepressant to an initial mood stabilizer for treatment of patients with bipolar depression. Am J Psychiatry 2000; 157:124-126
21. Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, Mitchell PB, Centorrino F, Risser R, Baker RW, Evans AR, Beymer K, Dube S, Tollefson GD, Breier A: Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003; 60:1079-1088
22. Calabrese JR, Keck PE Jr, Macfadden W, Minkwitz M, Ketter TA, Weisler RH, Cutler AJ, McCoy R, Wilson E, Mullen J (BOLDER Study Group): A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005; 162:1351-1360
23. Goldberg JF, Burdick KE, Endick CJ: Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry 2004; 161:564-566
24. Zarate CA Jr, Payne JL, Singh J, Quiroz JA, Luckenbaugh DA, Denicoff KD, Charney DS, Manji HK: Pramipexole for bipolar II depression: a placebo-controlled proof of concept study. Biol Psychiatry 2004; 56:54-60
25. Zarate CA Jr, Quiroz JA, Singh JB, Denicoff KD, De Jesus G, Luckenbaugh DA, Charney DS, Manji HK: An open-label trial of the glutamate-modulating agent riluzole in combination with lithium for the treatment of bipolar depression. Biol Psychiatry 2005; 57:430-432
26. Bowden CL, Calabrese JR, Sachs G, Yatham LN, Asghar SA, Hompland M, Montgomery P, Earl N, Smoot TM, DeVeaugh-Geiss J (Lamictal 606 Study Group): A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. Arch Gen Psychiatry 2003; 60:392-100
27. Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, Rudd GD (Lamictal 602 Study Group): A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. J Clin Psychiatry 1999; 2:79-88
28. Calabrese JR, Suppes T, Bowden CL, Sachs GS, Swann AC, McElroy SL, Kusumakar V, Ascher JA, Earl NL, Greene PL, Monaghan ET (Lamictal 614 Study Group): A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. J Clin Psychiatry 2000; 11:841-850
29. Calabrese JR, Bowden CL, Sachs G, Yatham LN, Behnke K, Mehtonen OP, Montgomery P, Ascher J, Paska W, Earl N, DeVeaugh-Geiss J (Lamictal 605 Study Group): A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. J Clin Psychiatry 2003; 9:1013-1024
30. Goodwin GM, Bowden CL, Calabrese JR, Grunze H, Kasper S, White R, Greene P, Leadbetter R: A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. J Clin Psychiatry 2004; 3:432-141
31. Chengappa KN, Levine J, Gershon S, Mallinger AG, Hardan A, Vagnucci A, Pollock B, Luther J, Buttenfield J, Verfaule S, Kupfer DJ: Inositol as an add-on treatment for bipolar depression. Bipolar Disord 2000; 2:47-55
32. Hirschfeld RMA, Keck PE Jr, Kramer M, Karcher K, Canuso C, Eerdekens M, Grossman F: Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry 2004; 161:1057-1065
33. Sachs GS, Thase ME, Otto MW, Bauer M, Miklowitz D, Wisniewski SR, Lavori P, Lebowitz B, Rudorfer M, Frank E, Nierenberg AA, Fava M, Bowden C, Ketter T, Marangell L, Calabrese J, Kupfer D, Rosenbaum JF: Rationale, design, and methods of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Biol Psychiatry 2003; 53:1028-1042
34. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The Mini-International Neuropsychiatric Interview (MINI): 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
35. Sachs GS, Guille C, McMurrich SL: A clinical monitoring form for mood disorders. Bipolar Disord 2002; 4:323-327
36. Montgomery SA, Åsberg M: A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389
37. Young RC, Biggs JT, Ziegler VE, Meyer DA: A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133:429-435
38. Lavori PW, Dawson R, Rush AJ: Flexible treatment strategies in chronic disease: clinical and research implications. Biol Psychiatry 2000; 48:605-614