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January 1997, Vol 54, No. 1 >
Article | January 1997

Clinical Risk Following Abrupt and Gradual Withdrawal of Maintenance Neuroleptic Treatment

Adele C. Viguera, MD; Ross J. Baldessarini, MD; James D. Hegarty, MD, MPH; Daniel P. van Kammen, MD, PhD; Mauricio Tohen, MD, DrPH
Arch Gen Psychiatry. 1997;54(1):49-55. doi:10.1001/archpsyc.1997.01830130055011
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Background:  Abrupt discontinuation of long-term psychotropic medication can be followed by a high risk of early relapse. This study aimed to quantify the relapse risk over time in patients with schizophrenia following discontinuation of maintenance neuroleptic treatment.

Methods:  Data on the timing of relapses in patients with schizophrenia after withdrawal from neuroleptic therapy were located by a computerized literature search, combined with new data, and evaluated by survival analysis.

Results:  Data were found for 1210 schizophrenic subjects: 1006 (795 inpatients and 211 outpatients) were withdrawn abruptly from oral neuroleptic therapy, and 204 discontinued treatment gradually (≥3 weeks) or stopped treatment with depot neuroleptic drugs. After abrupt discontinuation of oral medication, the risk of relapse reached 50% within 30 weeks, with remarkably little additional risk thereafter to 3.7 years; inpatients relapsed more rapidly than did outpatients (10 vs 18 weeks to a 25% relapse risk). In studies including subjects whose drug therapy was withdrawn abruptly (n=49) vs gradually (n=58), relapse was earlier after abrupt discontinuation (25% risk in 6 vs 10 weeks), with a persistent difference for at least 6 months.

Conclusions:  The relapse risk was high within 6 months of discontinuing oral neuroleptic therapy, particularly in hospitalized patients. Most patients who remained stable for 6 months continued to do so for long periods without medication, indicating clinical heterogeneity. Drug-withdrawal stressors, related to long-term pharmacodynamic adaptations, are implicated. Since the risk was lower after gradually discontinuing oral neuroleptic therapy or stopping depot injections, early relapse may be spared by a slow removal of drugs.

REFERENCES

1 +
Baldessarini RJ. Chemotherapy in Psychiatry: Principles and Practice . Cambridge, Mass; Harvard University Press; 1985;.
2 +
Baldessarini RJ.  Drugs and the treatment of psychiatric disorders: antipsychotic and antianxiety agents . In: Harden W, Rudin W, Molinoff PB, Rall T, eds. Goodman and Gilman's the Pharmacologic Basis of Therapeutics . 9th ed. New York, NY: McGraw-Hill Book Co; 1996;:399-430.
3 +
Gilbert PL, Harris MJ, Jeste DV.  Neuroleptic withdrawal in schizophrenic patients: a review of the literature . Arch Gen Psychiatry . 1995;;52:173-188.
4 +
Baldessarini RJ, Cohen BM, Teicher MH.  Significance of neuroleptic dose and plasma level in the pharmacological treatment of psychoses . Arch Gen Psychiatry . 1988;;45:79-91.
5 +
McEvoy JP, Hogarty GE, Steingard S.  Optimal dose of neuroleptic in acute schizophrenia: controlled study of the neuroleptic threshold and higher haloperidol dose . Arch Gen Psychiatry . 1991;;48:739-745.
6 +
Inderbitzen LB, Lewine RRJ, Scheller-Gilkey G, Swofford CD, Egan GJ, Gloersen BA, Vidanagama BP, Waternaux C.  A double-blind dosage reduction trial of fluphenazine decanoate in chronic, unstable schizophrenic patients . Am J Psychiatry . 1994;;151:1753-1759.
7 +
Smith RC.  Lower-dose therapy with traditional neuroleptics in chronically hospitalized schizophrenic patients . Arch Gen Psychiatry . 1994;;51:427-429.
8 +
Carpenter WT, Hanlon TE, Heinrichs DW, Summerfelt AT, Kirkpatrick B, Levine J, Buchanan RW.  Continuous vs targeted medication in schizophrenic outpatients: outcome results . Am J Psychiatry . 1990;;147:1138-1148.
9 +
Herz MI, Glazer WM, Mostert MA, Sheard MA, Szymanski HV, Hafez H, Mirza M, Vana J.  Intermittent vs maintenance medication in schizophrenia: two-year results . Arch Gen Psychiatry . 1991;;48:333-339.
10 +
Jolley AG, Hirsch SR.  Continuous vs intermittent neuroleptic therapy in schizophrenia . Drug Saf . 1993;;8:331-339.
11 +
Baldessarini RJ, Frankenburg FR.  Clozapine—a novel antipsychotic agent . N Engl J Med . 1991;;324:746-754.
12 +
Meltzer HY.  Atypical antipsychotic drugs . In: Bloom FE, Kupfer DJ, eds. Psychopharmacology: the Fourth Generation of Progress . New York, NY: Raven Press; 1995;:1277-1286.
13 +
Rothman KJ, Michels KB.  The continuing unethical use of placebo controls . N Engl J Med . 1994;;331:294-298.
14 +
Taubes G.  Use of placebo controls in clinical trials disputed . Science . 1995;;267:25-26.
15 +
Baldessarini RJ, Viguera AC.  Neuroleptic withdrawal in schizophrenic patients . Arch Gen Psychiatry . 1995;;52:189-192.
16 +
Jeste DV, Gilbert PL, McAdams LA, Harris MJ.  Considering neuroleptic maintenance and taper on a continuum: need for individual rather than dogmatic approach . Arch Gen Psychiatry . 1995;;52:209-212.
17 +
Baldessarini RJ, Suppes T, Tondo L.  Lithium withdrawal in bipolar disorder: implications for clinical practice and experimental therapeutics research . Am J Ther . 1996;;3:492-496.
18 +
Lader M.  Benzodiazepines: a risk-benefit profile . CNS Drugs . 1994;;1:377-387.
19 +
Dilsaver SC.  Heterocyclic antidepressant, monoamine oxidase inhibitor and neuroleptic withdrawal phenomena . Prog Neuropsychopharmacol Biol Psychiatry . 1990;;14:137-161.
20 +
Suppes T, Baldessarini RJ, Faedda GL, Tohen M.  Risk of recurrence following discontinuation of lithium treatment in bipolar disorder . Arch Gen Psychiatry . 1991;;48:1082-1088.
21 +
Faedda GL, Tondo L, Baldessarini RJ, Suppes T, Tohen M.  Outcome after rapid vs gradual discontinuation of lithium in bipolar mood disorders . Arch Gen Psychiatry . 1993;;50:448-455.
22 +
Suppes T, Baldessarini RJ, Faedda GL, Tondo L, Tohen M.  Discontinuing maintenance treatment in bipolar manic-depression: risks and implications . Harvard Rev Psychiatry . 1993;;1:131-144.
23 +
Kupfer DJ, Frank E, Perel JM, Cornes C, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ.  Five-year outcome for maintenance therapies in recurrent depression . Arch Gen Psychiatry . 1992;;49:769-773.
24 +
Baldessarini RJ, Tondo L, Faedda G, Floris G, Suppes T, Rudas N.  Effects of the rate of discontinuing lithium maintenance treatment in bipolar disorders . J Clin Psychiatry . 1996;;57:441-448.
25 +
Olson GW, Peterson DB.  Sudden removal of tranquilizing drugs from chronic psychiatric patients . J Nerv Ment Dis . 1960;;131:252-255.
26 +
Whittaker CB, Hoy RM.  Withdrawal of perphenazine in chronic schizophrenia . Br J Psychiatry . 1963;;109:422-427.
27 +
Caffey EM, Diamond LS, Frank TV, Grasberger JC, Herman L, Klett CJ, Rothstein C.  Discontinuation or reduction of chemotherapy in chronic schizophrenics . J Chronic Dis . 1964;;17:347-358.
28 +
Greenberg LM, Roth S.  Differential effects of abrupt vs gradual withdrawal of chlorpromazine in hospitalized schizophrenic patients . Am J Psychiatry . 1966;;123:221-226.
29 +
Engelhardt DM, Rosen B, Freedman N, Margolis R.  Phenothiazines in prevention of psychiatric hospitalization: delay or prevention of hospitalization, a reevaluation . Arch Gen Psychiatry . 1967;;16:98-101.
30 +
Prien RF, Cole JO, Belkin NF.  Relapse in chronic schizophrenics following abrupt withdrawal of tranquilizing medication . Br J Psychiatry . 1969;;115:679-686.
31 +
Leff JP, Wing JK.  Trial of maintenance therapy in schizophrenia . Br J Psychiatry . 1971;;11:599-604.
32 +
Hogarty GE, Goldberg SC, Schooler NR, Ulrich RF.  Drug and sociotherapy in the aftercare of schizophrenic patients: two-year relapse rate . Arch Gen Psychiatry . 1974;;31:603-608.
33 +
Clark ML, Huber WK, Hill D, Wood F, Costiloe JP.  Pimozide in chronic schizophrenic outpatients . Dis Nerv Syst . 1975;;36:137-141.
34 +
Levine J, Schooler NR, Severe J, Escobar J, Gelenberg AJ, Mandel M, Sovner R, Steinbook R.  Discontinuation of oral and depot fluphenazine in schizophrenic patients after one year of continuous medication . Adv Biochem Psychopharmacol . 1980;;24:483-495.
35 +
Cheung HK.  Schizophrenics fully remitted on neuroleptics for 3-5 years—to stop or continue drugs? Br J Psychiatry . 1981;;138:490-494.
36 +
van Kammen DP, Agren H, Yao JK, O'Connor DT, Gurklis J, Peters JL.  Noradrenergic activity and prediction of psychotic relapse following haloperidol withdrawal in schizophrenia . Am J Psychiatry . 1994;;51:379-384.
37 +
van Kammen DP, Kelley ME, Gurklis JA, Gilbertson MW, Yao JK, Condray R, Peters JL. Predicting duration of clinical stability following haloperidol withdrawal in schizophrenia. Neuropsychopharmacology. In press.
38 +
Branchey MH, Branchey LB, Richardson MA.  Effects of neuroleptic adjustment on clinical condition in tardive dyskinesia in schizophrenic patients . Am J Psychiatry . 1981;;138:608-612.
39 +
Crow TJ, MacMillan JF, Johnson AL, Johnstone EC.  Randomized controlled trial of prophylactic neuroleptic treatment . Br J Psychiatry . 1986;;148:120-127.
40 +
Dencker SJ, Lepp M, Malm U.  Do schizophrenics well adapted in the community need neuroleptics? a depot withdrawal study . Acta Psychiatr Scand . 1980;;61( (suppl 279) ):64-76.
41 +
Wistedt B.  A depot neuroleptic withdrawal study: a controlled study of the withdrawal of depot fluphenazine decanoate and depot flupenthixol decanoate in chronic schizophrenic patients . Acta Psychiatr Scand . 1981;;64:65-84.
42 +
Sampath G, Shah A, Krska J, Soni SD.  Discontinuation in the very stable schizophrenic patient: relapse rates and serum neuroleptic levels . Hum Psychopharmacol . 1992;;7:255-264.
43 +
Cox DR.  Regression models and life tables . J R Stat Soc Ser B . 1972;;34:187-220.
44 +
Kahn HA, Sempos CT. Statistical Methods in Epidemiology . New York, NY: Oxford University Press Inc; 1989;.
45 +
Hegarty JD, Baldessarini RJ, Tohen M, Waternaux CM, Oepen G.  One hundred years of schizophrenia: a meta-analysis of the outcome literature . Am J Psychiatry . 1994;;151:1409-1416.
46 +
Fenton WS, McGlashan TH.  Natural history of schizophrenia subtypes . Arch Gen Psychiatry . 1991;;48:969-977.
47 +
Ram R, Bromet EJ, Eaton WW, Pato C, Schwartz JE.  The natural course of schizophrenia: a review of first-admission studies . Schizophr Bull . 1992;;18:185-207.
48 +
Cohen BM, Tsuneizumi T, Baldessarini RJ, Campbell A, Babb S.  Differences between antipsychotic drugs in persistence of brain levels and behavioral effects . Psychopharmacology (Berl) . 1992;;108:338-344.
49 +
Baldessarini RJ, Tarsy D.  Relationship of the actions of neuroleptic drugs to the pathophysiology of tardive dyskinesia . Int Rev Neurobiol . 1979;;21:1-45.
50 +
Müller P, Seeman P.  Dopaminergic supersensitivity after neuroleptics: timecourse and specificity . Psychopharmacology (Berl) . 1978;;60:1-11.
51 +
Eklund K, Forsman A.  Minimal effective dose and relapse—double-blind trial: haloperidol decanoate vs placebo . Clin Neuropharmacol . 1991;;14( (suppl 2) ):S7-S17.
52 +
Baldessarini RJ, Gardner DM, Garver DL.  Conversions from clozapine to other antipsychotics . Arch Gen Psychiatry . 1995;;52:000-000.
53 +
Lieberman JA, Alvir J, Geisler S, Ramos-Lorenzi J, Woerner M, Novacenko H, Cooper T, Kane JM.  Methylphenidate response, psychopathology and tardive dyskinesia as predictors of relapse in schizophrenia . Neuropsychopharmacology . 1994;;11:107-118.
54 +
Chou J C-Y.  Recent advances in the treatment of acute mania . J Clin Psychopharmacol . 1991;;11:3-21.
55 +
Sernyk MJ, Woods SW.  Chronic neuroleptic use in manic depressive illness . Psychopharmacol Bull . 1993;;29:375-381.

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1 +
Baldessarini RJ. Chemotherapy in Psychiatry: Principles and Practice . Cambridge, Mass; Harvard University Press; 1985;.
2 +
Baldessarini RJ.  Drugs and the treatment of psychiatric disorders: antipsychotic and antianxiety agents . In: Harden W, Rudin W, Molinoff PB, Rall T, eds. Goodman and Gilman's the Pharmacologic Basis of Therapeutics . 9th ed. New York, NY: McGraw-Hill Book Co; 1996;:399-430.
3 +
Gilbert PL, Harris MJ, Jeste DV.  Neuroleptic withdrawal in schizophrenic patients: a review of the literature . Arch Gen Psychiatry . 1995;;52:173-188.
4 +
Baldessarini RJ, Cohen BM, Teicher MH.  Significance of neuroleptic dose and plasma level in the pharmacological treatment of psychoses . Arch Gen Psychiatry . 1988;;45:79-91.
5 +
McEvoy JP, Hogarty GE, Steingard S.  Optimal dose of neuroleptic in acute schizophrenia: controlled study of the neuroleptic threshold and higher haloperidol dose . Arch Gen Psychiatry . 1991;;48:739-745.
6 +
Inderbitzen LB, Lewine RRJ, Scheller-Gilkey G, Swofford CD, Egan GJ, Gloersen BA, Vidanagama BP, Waternaux C.  A double-blind dosage reduction trial of fluphenazine decanoate in chronic, unstable schizophrenic patients . Am J Psychiatry . 1994;;151:1753-1759.
7 +
Smith RC.  Lower-dose therapy with traditional neuroleptics in chronically hospitalized schizophrenic patients . Arch Gen Psychiatry . 1994;;51:427-429.
8 +
Carpenter WT, Hanlon TE, Heinrichs DW, Summerfelt AT, Kirkpatrick B, Levine J, Buchanan RW.  Continuous vs targeted medication in schizophrenic outpatients: outcome results . Am J Psychiatry . 1990;;147:1138-1148.
9 +
Herz MI, Glazer WM, Mostert MA, Sheard MA, Szymanski HV, Hafez H, Mirza M, Vana J.  Intermittent vs maintenance medication in schizophrenia: two-year results . Arch Gen Psychiatry . 1991;;48:333-339.
10 +
Jolley AG, Hirsch SR.  Continuous vs intermittent neuroleptic therapy in schizophrenia . Drug Saf . 1993;;8:331-339.
11 +
Baldessarini RJ, Frankenburg FR.  Clozapine—a novel antipsychotic agent . N Engl J Med . 1991;;324:746-754.
12 +
Meltzer HY.  Atypical antipsychotic drugs . In: Bloom FE, Kupfer DJ, eds. Psychopharmacology: the Fourth Generation of Progress . New York, NY: Raven Press; 1995;:1277-1286.
13 +
Rothman KJ, Michels KB.  The continuing unethical use of placebo controls . N Engl J Med . 1994;;331:294-298.
14 +
Taubes G.  Use of placebo controls in clinical trials disputed . Science . 1995;;267:25-26.
15 +
Baldessarini RJ, Viguera AC.  Neuroleptic withdrawal in schizophrenic patients . Arch Gen Psychiatry . 1995;;52:189-192.
16 +
Jeste DV, Gilbert PL, McAdams LA, Harris MJ.  Considering neuroleptic maintenance and taper on a continuum: need for individual rather than dogmatic approach . Arch Gen Psychiatry . 1995;;52:209-212.
17 +
Baldessarini RJ, Suppes T, Tondo L.  Lithium withdrawal in bipolar disorder: implications for clinical practice and experimental therapeutics research . Am J Ther . 1996;;3:492-496.
18 +
Lader M.  Benzodiazepines: a risk-benefit profile . CNS Drugs . 1994;;1:377-387.
19 +
Dilsaver SC.  Heterocyclic antidepressant, monoamine oxidase inhibitor and neuroleptic withdrawal phenomena . Prog Neuropsychopharmacol Biol Psychiatry . 1990;;14:137-161.
20 +
Suppes T, Baldessarini RJ, Faedda GL, Tohen M.  Risk of recurrence following discontinuation of lithium treatment in bipolar disorder . Arch Gen Psychiatry . 1991;;48:1082-1088.
21 +
Faedda GL, Tondo L, Baldessarini RJ, Suppes T, Tohen M.  Outcome after rapid vs gradual discontinuation of lithium in bipolar mood disorders . Arch Gen Psychiatry . 1993;;50:448-455.
22 +
Suppes T, Baldessarini RJ, Faedda GL, Tondo L, Tohen M.  Discontinuing maintenance treatment in bipolar manic-depression: risks and implications . Harvard Rev Psychiatry . 1993;;1:131-144.
23 +
Kupfer DJ, Frank E, Perel JM, Cornes C, Mallinger AG, Thase ME, McEachran AB, Grochocinski VJ.  Five-year outcome for maintenance therapies in recurrent depression . Arch Gen Psychiatry . 1992;;49:769-773.
24 +
Baldessarini RJ, Tondo L, Faedda G, Floris G, Suppes T, Rudas N.  Effects of the rate of discontinuing lithium maintenance treatment in bipolar disorders . J Clin Psychiatry . 1996;;57:441-448.
25 +
Olson GW, Peterson DB.  Sudden removal of tranquilizing drugs from chronic psychiatric patients . J Nerv Ment Dis . 1960;;131:252-255.
26 +
Whittaker CB, Hoy RM.  Withdrawal of perphenazine in chronic schizophrenia . Br J Psychiatry . 1963;;109:422-427.
27 +
Caffey EM, Diamond LS, Frank TV, Grasberger JC, Herman L, Klett CJ, Rothstein C.  Discontinuation or reduction of chemotherapy in chronic schizophrenics . J Chronic Dis . 1964;;17:347-358.
28 +
Greenberg LM, Roth S.  Differential effects of abrupt vs gradual withdrawal of chlorpromazine in hospitalized schizophrenic patients . Am J Psychiatry . 1966;;123:221-226.
29 +
Engelhardt DM, Rosen B, Freedman N, Margolis R.  Phenothiazines in prevention of psychiatric hospitalization: delay or prevention of hospitalization, a reevaluation . Arch Gen Psychiatry . 1967;;16:98-101.
30 +
Prien RF, Cole JO, Belkin NF.  Relapse in chronic schizophrenics following abrupt withdrawal of tranquilizing medication . Br J Psychiatry . 1969;;115:679-686.
31 +
Leff JP, Wing JK.  Trial of maintenance therapy in schizophrenia . Br J Psychiatry . 1971;;11:599-604.
32 +
Hogarty GE, Goldberg SC, Schooler NR, Ulrich RF.  Drug and sociotherapy in the aftercare of schizophrenic patients: two-year relapse rate . Arch Gen Psychiatry . 1974;;31:603-608.
33 +
Clark ML, Huber WK, Hill D, Wood F, Costiloe JP.  Pimozide in chronic schizophrenic outpatients . Dis Nerv Syst . 1975;;36:137-141.
34 +
Levine J, Schooler NR, Severe J, Escobar J, Gelenberg AJ, Mandel M, Sovner R, Steinbook R.  Discontinuation of oral and depot fluphenazine in schizophrenic patients after one year of continuous medication . Adv Biochem Psychopharmacol . 1980;;24:483-495.
35 +
Cheung HK.  Schizophrenics fully remitted on neuroleptics for 3-5 years—to stop or continue drugs? Br J Psychiatry . 1981;;138:490-494.
36 +
van Kammen DP, Agren H, Yao JK, O'Connor DT, Gurklis J, Peters JL.  Noradrenergic activity and prediction of psychotic relapse following haloperidol withdrawal in schizophrenia . Am J Psychiatry . 1994;;51:379-384.
37 +
van Kammen DP, Kelley ME, Gurklis JA, Gilbertson MW, Yao JK, Condray R, Peters JL. Predicting duration of clinical stability following haloperidol withdrawal in schizophrenia. Neuropsychopharmacology. In press.
38 +
Branchey MH, Branchey LB, Richardson MA.  Effects of neuroleptic adjustment on clinical condition in tardive dyskinesia in schizophrenic patients . Am J Psychiatry . 1981;;138:608-612.
39 +
Crow TJ, MacMillan JF, Johnson AL, Johnstone EC.  Randomized controlled trial of prophylactic neuroleptic treatment . Br J Psychiatry . 1986;;148:120-127.
40 +
Dencker SJ, Lepp M, Malm U.  Do schizophrenics well adapted in the community need neuroleptics? a depot withdrawal study . Acta Psychiatr Scand . 1980;;61( (suppl 279) ):64-76.
41 +
Wistedt B.  A depot neuroleptic withdrawal study: a controlled study of the withdrawal of depot fluphenazine decanoate and depot flupenthixol decanoate in chronic schizophrenic patients . Acta Psychiatr Scand . 1981;;64:65-84.
42 +
Sampath G, Shah A, Krska J, Soni SD.  Discontinuation in the very stable schizophrenic patient: relapse rates and serum neuroleptic levels . Hum Psychopharmacol . 1992;;7:255-264.
43 +
Cox DR.  Regression models and life tables . J R Stat Soc Ser B . 1972;;34:187-220.
44 +
Kahn HA, Sempos CT. Statistical Methods in Epidemiology . New York, NY: Oxford University Press Inc; 1989;.
45 +
Hegarty JD, Baldessarini RJ, Tohen M, Waternaux CM, Oepen G.  One hundred years of schizophrenia: a meta-analysis of the outcome literature . Am J Psychiatry . 1994;;151:1409-1416.
46 +
Fenton WS, McGlashan TH.  Natural history of schizophrenia subtypes . Arch Gen Psychiatry . 1991;;48:969-977.
47 +
Ram R, Bromet EJ, Eaton WW, Pato C, Schwartz JE.  The natural course of schizophrenia: a review of first-admission studies . Schizophr Bull . 1992;;18:185-207.
48 +
Cohen BM, Tsuneizumi T, Baldessarini RJ, Campbell A, Babb S.  Differences between antipsychotic drugs in persistence of brain levels and behavioral effects . Psychopharmacology (Berl) . 1992;;108:338-344.
49 +
Baldessarini RJ, Tarsy D.  Relationship of the actions of neuroleptic drugs to the pathophysiology of tardive dyskinesia . Int Rev Neurobiol . 1979;;21:1-45.
50 +
Müller P, Seeman P.  Dopaminergic supersensitivity after neuroleptics: timecourse and specificity . Psychopharmacology (Berl) . 1978;;60:1-11.
51 +
Eklund K, Forsman A.  Minimal effective dose and relapse—double-blind trial: haloperidol decanoate vs placebo . Clin Neuropharmacol . 1991;;14( (suppl 2) ):S7-S17.
52 +
Baldessarini RJ, Gardner DM, Garver DL.  Conversions from clozapine to other antipsychotics . Arch Gen Psychiatry . 1995;;52:000-000.
53 +
Lieberman JA, Alvir J, Geisler S, Ramos-Lorenzi J, Woerner M, Novacenko H, Cooper T, Kane JM.  Methylphenidate response, psychopathology and tardive dyskinesia as predictors of relapse in schizophrenia . Neuropsychopharmacology . 1994;;11:107-118.
54 +
Chou J C-Y.  Recent advances in the treatment of acute mania . J Clin Psychopharmacol . 1991;;11:3-21.
55 +
Sernyk MJ, Woods SW.  Chronic neuroleptic use in manic depressive illness . Psychopharmacol Bull . 1993;;29:375-381.

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