Drug Therapy in the Prevention of Recurrences in Uinpolar and Bipolar

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Drug Therapy in the Prevention of Recurrences in Uinpolar and Bipolar l.i Drug Therapyin the Preventionof Recurrencesin tJnipolarand BipolarAffeetive Disorders Report of the NIMII CollaborativeStudy GroupComparir:rg Lithium Carbonate, Imipraririne,and a Lithiurii Carbonate-Imipi'amineCornbination Robert F. Prien, PhD; David J. Iiupfer, MD; Petel A" l{ansky, MD; JoyceG. Small, l'{D; Vicente B. Ttrason,MD; Cai'lyleB. Voss,MD; l4rayneE. Johnson c ln a double-blind, long-term follow-up study, 117bipolar f-\uring the pasttrvo decades, it h;,r becomeincreasingll patients received lithium carbonate, imipramine hydrochlo- LJ clear that niajor affective illness should be viewer ride, or both and 150 unipolar patients received lithium car- longitudinally rather than solely iir telms of the acutt bonate,imipramine, both lithiumcarbonate and imipramine, or episode.There is convincingeviden:e from studieson thr placebo. With bipolar patients, lithium carbonate and the courseof affective disorders that the majority of patientr combinationtreatment were superiorto imipraminein prevent- who havean initial episodeof major ciepressionor maniawil ing manic recurrencer and were as effectiveas imipramine in suffei' recurrences.L' Horvevef, maintenance pharmaco preventing manic recurrenees and were as elfective as im- therapy aimedat preventingthe occlli'renceofnew episodei ipramine in preventingdepressive episodes. The combination continuesto be studied far less adecluatelythan treatmen' treatment provided no advantage over lithium carbonate clirectedat the acuteepisode. As a result, there aremajor alone.With unipolar patients,imipramine and the combination gaps in knorvledgeregarding the long-term treatment anr treatment were more effective than lithiurn carbonate and managementof affectivedisolclers. placebo in preventingdepressive recurrences. The combina- The only conclusivefinding regarclinglong-tet'm preven tion treatment provided no advantageover imipraminealone. tive drug treatment is that lithium carbonateis effectiveit The lithium carbonale-treated group had fewer manic epi- preventingmanic lecurrencesin patients lvith bipolar clis sodes than the other groups. Treatmentoutcome, which was otder'.toThe effectivenessof lithium carbonale and anti evaluatedprimarily in terms ol the occurrenceol major depres- depressantdlugs in preventingdepressive reculrences it sion or manic episodes,was significantlyrelated lo character- bipolarand unipolardisorders is lessclear. istics of the index episode, ie, the episode that brought the A revien' of the six studies comparingIithium carbonatt patient into the study. against placeboin bipolar disordeCshowecl that lithiun (Arch Gen Psychiatry1984;41 :1096-1104) carbonate-trea.ledpatients had ferver deplessive tecui' lencesthan placebo-treatedpatients in eachof the trials Acceptedfor publicationApril 12, 1981. but that in only one study was tlie difference bet*'eei From the Pharniacologicancl Somatic t'eatments Rese:LrchBrarrch, treatments statistically significant at the \Vo level. Otrt Division of Extramural ResearchPrograms, National Institute of l\lenlal problemin interpleting the results for depressiverecur Health,Rochville, I'Id (Dr Prienand l{rJohnson); Department ofPsychia- rencesis that raost of the failui'esin placebo-tleatetlpa try, University of Piltsburgh Schoolof Medicine(Dr Kupfpr); Department of Psychiatry,Albanl, (NY) Medical College1Dr Mansky);Department of tients occurreclin those who had had a manic episocle llental Health, LaRue D. Carter MemorialHospital, Indianapolis (Dr leavinga relatively small clatabase from which to establisl Small); Department of Psychiatry, St Paul (Minn)-RamseyHospital and statisticalsignificince for ciepressiverecurrences. The onll Medical Center (Dr Tuason);and the Department of Psychiatry, iVlaine controlieclevaluation of an antidepressantin bipolardisor lledical Center,Portland (Dr \toss). ar Reprint requeststo l.lationalInstitute of Mental Health, Room 10C-06, cle15indicated that imipramineh;'drochloride was equally. ParklarvnBuilding, 5600 Fishers Lane, Rockville, MD 20857(Dr Prien). effective as iithium carbouate in preventing depresstvt 1096 Arch Gen Psvchiatrv-Vol41, Nov 1984 Unipolarand Bipolarlllness-Prien et a episoclesbut v;assiguiiiceirtly less effective in prevetiting invoh'eda two-yeardouble-blind coinpalison of the study treat- manlcr"ec!rrl.enceS. lnents. Studiescomparing lithium carbonateagainst placebo in PreliminaryPhase the mainteuancetreatrnent of unipolarillness suggest an advantageI'or lithium ,:arbonaie.""Horvever, the smalltotal During the index episodethe patient receivedthe treatment of numbefofplacebo-treated patients evaluated in thesetlials choiceof the psychiatrist lesponsiblefor preliminary phasecare. (92 in seven siudies) arrd diagnostit-allyheterogeneous Aftel the acute syrnptomswere controlled, the patient received populaticnspose diffici,rlties for interpreling findingsancl the ccmbinationof lilhium carbonateand imipranine at mainte- nance levels. Imipramine h,ydlochloridewas lhe r€asorrswhy lithiurncirlbonate has nct dose maintained at are 1;i'ilnai'/ been 150 mg/day. Patients rn-howere unable to tolerate 150 mg/day approvedby LheFood and Drug Administration for the long- becauseof adversereactions or medicalcomplications could have term naintenancetreatment of unipolar disorder.DFive theil dosagereduced to a minimurnof 75mg/day. The serumlevel of stucliescorrrparing litj:iurn calbonateagainst a.nlidepres- lithiurnivas targel.ecl at 0.6to 0.9mEq/L. Thepatient was assigned santsfoirncl litliium cat'bonateto be equallyas effectiveas to double-blindmerlication (ie, enteredthe maintenancephase) imiprart'rinetand arniti'iptylinehydrochloride'n ancl ntore after trvoconditions ivere satisfied: (1) the patient had remainedon effectivelhari imipra-ntine,"maprotiline hydrochloride,'3 stable maintenancecloses (at least 75 mg/day of imipramine andmianserirr l.ivdrocirloride.'" Ttwo of t-hesesluclies'r" did hydrochloride and a serum lithium level of 0.6 mEq/L) for trvo (2) not use a placeboconirol ancltwo others'nuusetl placebo consecutivemonths, and the patient had a scoleof more than 60 the an li and gl'oupsconsisting of onl;7six atrdseven patients. on GASand SDX{total depressionscore a total mania scoreof lessthan ?. The fact that neithel lithiunrcalbonate nol anticleoi'es- santssrrch as imiplam,ne and amitliptylir.reale conipletely MaintenancePhase satisfactoi'yrnainteneitce tleahments foi' bipolai' and Bipolar and unipolar patients r,vererandomized separately to unipolar tlisoi'clershas led lo a search for albeirrat,ive maintenancetreatment regimens.Bipolar patientsli'ere randomly treatments.One altelniitiveis the combinationof lithiurn assignedto receiveone of three treatments:lithium carbonate, carbonateancl an antidepressant.The rabionalefor the imipramine, or the combination of ljthiuur cai'bonatearrd im- combinationis that litl,iurn carbonatewill ltrevent manic ipramine. Unipolar patients ruele raritlomly assignedto leceive recuri'encesanrl that t,he antideplessantr"rill prevent oneof four treatnrents:lithiurn carbonate, imipramine, the combi- depressiverecurl'ence:s. Although a recent cornllarisorr nation of lithium calhoirateand inriplanline,or placebo.Dosage betweenlithium carl.rolreteand the cornbinationof lithium was maintainedat tlie level establishedduling the preliminary phase. assigning carbonateand i:riilti'amine in with bipolarclisorcler In mairrtenancemi-.digrlbn, a "double-substitu- liatients tion" techniquewas usedto ensurepatient and ratel blindness. showecino significantdit'ference betu'een the two tleat- Patientsassigned to the combinationtleatrnent group continueclto ntettts,'"iirr: i-tr-,rnLiinatlr'ti len-rains a pci;ula.i'ti.catirlr:nt. lecei',,etlre rnaintenanceregimen establishe,l during the prelimi- To pro..,idernole clefinilive data regaldingthe lorrg-term nary phase.Patients assigned to the lithiurr carbonatetreatment prever-rtivetreatment cf recnli'ent affective illness, the group continuedon their lithium calbonateregimen and had an Pharmacologicancl Scrnatic Tlealn.rents Resear"ch Branch iraipramine placebo substituted for active inripramine. Those ofthe NationalInstitute of MentalHealth sponsorc,d a five- assignedlo the imiplaminetreatment gi'oup contiuued to receive hospitalcollaborillive pr'oject evaluating several long-telm imipraminervith a lithiurnplacebo substituted fr,)r active lithium maintenatr,:edrtrg trealments. The airrr of the cai'bonate.P:rtients assigned to receiveplacebo hatl an imiplamine lrlirnary placebo lithiurnplacebo rneclications. studyu,as to determine1,he compa.rative efficacies lithium and substitutedfor active of I\'ealments lr,ereadministered years. Patients carbonat,e, for t,r'o were seen imipramine, and the cornbinationof lithium at fcur- to six-weekintervals, u-ith inore frequent visits if there carbonateancl imipramirLe in lecurrentbipolar and unipolar rvasiircreased affective disturbance or adversereactiotrs to rnedi- disordei'.This article is the initial report of the study cation. Blood for determining sel'uinlithium levelswas drawn at findings. eachi'i-.it. Patients wele evaluatedat eachvisit by a psychiatrist ''blind" u'horvas to the iclentityof tire patie;rt'streatment. Neces- SUBJHCTSAND METHODS sary closageadjustments were made by :, nonblind psychiatlist who was rot involvedin the psychiatrice','aluation of the patient. Patierrts the stL:,'ivduring an epi-ocde enleled ol major unipolai' Outcome Measuresfor MaintenancePhase depression,rnajor bipolal ilepression,or mania (hereafter leferred to as the inder episode).To
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