The primary objective of this study was to compare the therapeutic effect of low-dose levosulpiride with pimozide in a representative sample of patients with negative symptoms of schizophrenia. As a secondary objective, possible synergism between haloperidol and levosulpiride was evaluated. The safety of the two drugs in association with haloperidol was also compared. This was a single-masked (the patient), randomized, controlled, clinical study performed on 20 hospitalized patients randomly assigned to one of two groups. The drugs under study were administered orally, during a 60-day period, at the following doses: levosulpiride 200 mg/d or pimozide 4 mg/d. All patients had chronic schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 3rd Edition, Revised, with predominant negative symptoms, following Andreasen's diagnostic criteria, based on rating scales for negative and positive symptoms of schizophrenia. Low-dose levosulpiride showed a definite therapeutic effect on negative symptoms of schizophrenia. The therapeutic activity of levosulpiride was higher than that of pimozide. A particular type of synergism between levosulpiride and haloperidol was also suggested, as negative symptoms of schizophrenia, which are not relieved by haloperidol alone, were significantly ameliorated by adding levosulpiride to the therapeutic schedule. The combination of levosulpiride plus haloperidol did not increase the incidence of side effects; in fact, the incidence of side effects with combination therapy was decreased in comparison with that of haloperidol monotherapy. The total number of side effects was similar during combination therapy with pimozide plus haloperidol and during haloperidol monotherapy.
Levosulpiride vs. pimozide in negative symptoms of schizophrenia
RUGGERI, Mirella;
1996-01-01
Abstract
The primary objective of this study was to compare the therapeutic effect of low-dose levosulpiride with pimozide in a representative sample of patients with negative symptoms of schizophrenia. As a secondary objective, possible synergism between haloperidol and levosulpiride was evaluated. The safety of the two drugs in association with haloperidol was also compared. This was a single-masked (the patient), randomized, controlled, clinical study performed on 20 hospitalized patients randomly assigned to one of two groups. The drugs under study were administered orally, during a 60-day period, at the following doses: levosulpiride 200 mg/d or pimozide 4 mg/d. All patients had chronic schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 3rd Edition, Revised, with predominant negative symptoms, following Andreasen's diagnostic criteria, based on rating scales for negative and positive symptoms of schizophrenia. Low-dose levosulpiride showed a definite therapeutic effect on negative symptoms of schizophrenia. The therapeutic activity of levosulpiride was higher than that of pimozide. A particular type of synergism between levosulpiride and haloperidol was also suggested, as negative symptoms of schizophrenia, which are not relieved by haloperidol alone, were significantly ameliorated by adding levosulpiride to the therapeutic schedule. The combination of levosulpiride plus haloperidol did not increase the incidence of side effects; in fact, the incidence of side effects with combination therapy was decreased in comparison with that of haloperidol monotherapy. The total number of side effects was similar during combination therapy with pimozide plus haloperidol and during haloperidol monotherapy.
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