Schizophrenia: Ziprasidone is indicated for the management of schizophrenia and other psychotic disorders and for maintenance of clinical improvement and prevention of relapse during continuation therapy.
The efficacy of ziprasidone in the treatment of the positive and negative symptoms of schizophrenia was established in four- and six-week placebo- and active-controlled clinical trials of hospitalized patients experiencing an acute exacerbation of the illness.
In a 52-week placebo-controlled clinical trial of chronic stable inpatients, ziprasidone demonstrated continuing improvement in primary negative symptoms and in global (psychological, social and occupational) functioning in this study of inpatient population over a 52-week period.
An analysis of the effect of ziprasidone on patients with clinically significant depressive symptoms, defined as ≥14 on the Montgomery-Asberg Depression Rating Scale (MADRS), was conducted in two multicenter placebo-controlled studies in acute schizophrenia. A statistically significant improvement versus placebo (p <0.05) in the MADRS was observed in these two studies in patients receiving 60 mg and 80 mg twice daily.
Bipolar Mania: Ziprasidone is indicated for the treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
Treatment of mania with ziprasidone for more than 3 weeks and prophylactic use in bipolar disorder have not been systematically evaluated in controlled clinical trials.
Bipolar I Disorder: Ziprasidone is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy studies in adult patients.
Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. Efficacy was established in a maintenance trail in adult patients. The efficacy of Ziprasidone as monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials.