A Randomized, Open-Label Study Comparing the Effects of Olanzapine Pamoate Depot with Oral Olanzapine on Treatment Outcomes in Outpatients with Schizophrenia - HGLQ

Phase 1

• Conditions: Schizophrenia

• Registration Number: EUCTR2005-004157-99-SK
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

[1] Male or female patients aged at least 18 and no more than 65 years.
[2] All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
[3] Patients must have schizophrenia that meets disease diagnostic criteria as defined in the DSM-IV or DSM-IV-TR (Sections 295.10, 295.20, 295.30, 295.60, or 295.90) and must be an outpatient at the time of study entry and randomization.
[4] Patients must:- have a CGI-S score d4 at Visits 1 and 2- have a PANSS score <70 at Visits 1 and 2- be an outpatient who has not been hospitalized for psychosis in the 8 weeks prior to Visit 1. Day hospitalization is allowed.
[5] Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol.
[6] Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an ICD.
[7] Patients who have experienced at least two episodes of clinical worsening of schizophrenia symptoms in the past 24 months such that hospitalization or an increased level of care surrounding the episode was required. Increased level of care can include the addition of or change to any of the following from a lower level of care: day hospital program; outpatient crisis management; short-term psychiatric treatment in an emergency room; or an addition, increase, or switch of medication. Medical history can be provided by patient, family member, or caregiver.
[8] Patients with unsatisfactory clinical response or experiencing AEs or who are nonadherent on current antipsychotic therapy such that the patient and the treating physician desire to change the patient’s therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[9] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
[10] Are employed by Lilly Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility.
[11] Have received treatment within the last 30 days with a drug that has not received regulatory approval for that indication at the time of study entry.
[12] Patients who have previously completed or withdrawn from this study after randomization, or patients who have participated in previous OPD studies.
[13] Patients who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, olanzapine orally disintegrating tablets, and/or OPD) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, who have exhibited a lack of efficacy/response to treatment, including treatment resistance, or who have a condition that would preclude use of a long-acting depot formulation.
[14] Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (60 days) prior to Visit 2.
[15] Patients with DSM-IV– or DSM-IV-TR–defined substance (except nicotine and caffeine) dependence within the past 30 days.
[16] Patients who received treatment with remoxipride within 6 months (180 days) prior to Visit 2.
[17] Patients who require concomitant treatment with any other medication with primarily central nervous system (CNS) activity, other than those allowed
[18] Patients who are actively suicidal (for example, any suicide attempts within the past month [30 days] or any current suicidal intent, including plan) in the opinion of the investigator.
[19] Patients with a history of allergic reaction to study drug(s) in any formulation.[20] Patients with known Human Immunodeficiency Virus positive (HIV+) status.
[21] Female patients who are either pregnant or nursing.
[22] Patients with known, uncorrected, narrow-angle glaucoma.
[23] Patients who have experienced one or more seizures without a clear and resolved etiology.
[24] Patients who have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis (absolute neutrophil count <500mm3) during the patient’s lifetime.
[25] Patients with serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit (ICU) hospitalization for the disease is anticipated within 6 months.
[26] Patients with acute, serious, or unstable medical conditions, including, but not limited to, inadequately controlled diabetes (glycated hemoglobin [HbA1c] >8%); severe hypertriglyceridemia (fasting triglycerides e500 mg/dL); hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accident (CVA); uncontrolled seizure disorders; serious acute systemic infection orimmunologic disease; unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (specificallycurrent absolute neutrophil count <1,500 mm3).
[27] Patients who received treatment with clozapine within 6 months prior to Visit 1.[28] Patients with alanine transaminase (ALT/SGPT) values e2 times the upper limit of normal (ULN) of the performing laboratory, or aspartate transaminase (AST/SGOT) values e3 times the

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified