Lithium augmentation fails to reduce symptoms in poorly responsive schizophrenic outpatients

Background: Nearly one third of patients suffering from schizophrenia do no t fully respond to antipsychotic medication. Safe, effective, and cost-effi cient methods to reduce symptoms are clearly needed; therefore, lithium as an adjunct to fluphenazine decanoate was tested in a placebo-controlled tri al in outpatients who were part of the Treatment Strategies of Schizophreni a (TSS) study. Method: Forty-one patients with DSM-III schizophrenia or schizoaffective di sorder were assigned to either adjunctive lithium or placebo after at least 6 months of fluphenazine decanoate treatment to stabilize symptoms had fai led. The trial was designed for 8 weeks of treatment, and patients assigned to placebo could afterward be administered lithium in an 8-week, open-labe l study. Results: Assessment of the intent-to-treat analysis revealed no significant differences in demographic variables between the lithium and placebo group s. Although both groups showed significant (p = .00135) improvement as meas ured by total scores on the Brief Psychiatric Rating Scale (BPRS), there we re no significant differences in response between the lithium and placebo g roups. Patients originally treated with placebo added to neuroleptic did no t have significantly greater improvement when receiving open-label adjuncti ve lithium. Conclusion: Although success with lithium augmentation therapy for persiste nt psychosis has been reported in the past, this study of well-characterize d patients showed no benefit for this common strategy, thus indicating that care be used in utilizing lithium augmentation.