Schizophrenia Clinical Trial
The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP) Depot in patients diagnosed with schizophrenia or schizoaffective disorder.
Since its introduction in the United States and Europe in the mid-1990s, olanzapine has been
distinguished from other antipsychotic medications (including other "atypical" compounds) by
its superior efficacy and safety profiles (Beasley et al. 1996a, 1996b; Tollefson et al.
1997).
Only older "typical" antipsychotics have been available in long-acting (depot) formulations.
They are most frequently prescribed to enhance compliance and, to a lesser degree, for
convenience, as the need for daily oral dosing is eliminated. The popularity of depot
formulations has diminished since the introduction of highly effective oral atypical
antipsychotics with vastly reduced side effects. However, long-acting injections remain an
important treatment option for many patients with psychotic disorders, and the need to
provide a safer, more effective depot formulation to this population is compelling.
Accordingly, an "atypical" depot of olanzapine, which can be administered every 2 to 4
weeks, has been developed to enhance convenience and compliance with antipsychotic therapy.
The depot formulation of olanzapine (LY170053) to be evaluated in this study is olanzapine
pamoate monohydrate (OPM) (the salt of pamoic acid and olanzapine), suitable for deep
intramuscular injection. Olanzapine Pamoate (OP) Depot (formerly referred to as IM
olanzapine depot in previous versions of protocol) consists of OPM powder, which is
suspended in an aqueous vehicle immediately prior to use. Several pamoate salts of other
registered drug products are currently approved for chronic oral administration in the
United States (for example, hydroxyzine pamoate and imipramine pamoate). Another pamoate
salt depot for intramuscular injection has also been approved in the US (TrelstarTM LA,
triptorelin pamoate for injectable suspension) for the treatment of prostate cancer.
As of March 2002, the pamoate formulation of OP Depot has been tested in 12 healthy subjects
and approximately 250 patients with schizophrenia in 2 clinical pharmacology studies,
F1D-EW-LOAZ and F1D-EW-LOBE, respectively, and one receptor occupancy (positron emission
tomography) study, F1D-EW-HGJW. Dosages included single doses up to 450mg and multiple doses
up to 405mg every 4weeks.
This open-label study will assess long-term efficacy 280 mg to 405mg of OP Depot
administered on a 3-week interval in patients with schizophrenia or schizoaffective disorder
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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