A Randomized, Open-Label Study Comparing the Effectiveness of Olanzapine Pamoate Depot with Haloperidol Decanoate in the Treatment of Schizophrenia

• Conditions: Schizophrenia

• Registration Number: EUCTR2007-003342-15-HU
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following 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 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV?; APA 1994) or Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR?; APA 2000) for a period of at least 2 years (diagnostic codes 295.10, 295.20, 295.30, 295.60, or 295.90); and must be an outpatient (that is, not be in need of acute inpatient stabilization) at the time of study entry and randomization.
[4]Patients must:
•have a PANSS score more than or equal to 60 at Visit 1 and Visit 2; and
•have a history of unsatisfactory clinical response to antipsychotic treatment for schizophrenia (except when treated with olanzapine or haloperidol). For this study, unsatisfactory clinical response is defined as persistent hallucinations, delusions, or thought disorder after at least 6 weeks of contiguous treatment (as supported by patient, medical, or family reports), with a therapeutic dose of at least 1 antipsychotic used for schizophrenia, not including haloperidol or olanzapine; and
•have demonstrated poor functioning in the past year in at least 2 areas of the patient’s life, such as occupational (work/school/vocational), social (interpersonal relations, whether problems within the family or outside the home), or self care.
[5]Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, understand the nature of the study, and have given informed consent.
[6]Patients must have experienced at least 2 episodes of clinical worsening of schizophrenia symptoms in the past 12 months such that hospitalization or increased levels of care were required. Increased levels 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.
[7]Patients must have experienced AEs to current antipsychotic treatment or have been nonadherent to current antipsychotic therapy (this includes patient nonadherent to haloperidol or oral olanzapine) such that the patient and the treating physician desire a change to 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

Patients will be excluded from the study if they meet any of the following criteria:
[8]Are investigator site personnel or are immediate family of investigator site personnel. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[9]Are employed by Lilly
[10]Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for that indication
[11]Have previously completed or withdrawn from the study after randomization, or have participated in previous OP Depot studies.
[12]Patients who have used olanzapine (any formulation) or haloperidol (any formulation) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine or haloperidol
[13]Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (56 days) prior to Visit 2.
[14]Patients with DSM-IV – or DSM-IV-TR–defined substance (except nicotine and caffeine) dependence within the past 30 days.
[15]Patients who received treatment with remoxipride within 6 months prior to Visit 2.
[16]Patients who require concomitant treatment with any other medication with primarily central nervous system (CNS) activity,
[17]Patients who are actively suicidal (for example, any suicide attempts within the past month or any current suicidal intent, including plan) in the opinion of the investigator.
[18]Patients with a history of allergic reaction to study drug(s) in any formulation.
[19]Patients with known Human Immunodeficiency Virus positive (HIV+) status.
[20]Female patients who are either pregnant or nursing.
[21]Patients with known, uncorrected, narrow-angle glaucoma.
[22]Patients who have experienced one or more seizures without a clear and resolved etiology.
[23]Patients who have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient’s lifetime.
[24]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.
[25]Patients with acute, serious, or unstable medical conditions, including, but not limited to, inadequately controlled diabetes ; severe hypertriglyceridemia; hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accident (CVA); uncontrolled seizure disorders; serious acute systemic infection or immunologic disease; unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic (eg, thyrotoxicosis), neurologic (eg, toxic CNS conditions), or hematologic diseases.
[26]Patients with a history of non-response to previous clozapine therapy within 6 months prior to Visit 1.
[27]Patients with ALT/SGPT values more than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory, or AST/SGOT values more than or equal to 3 times the ULN of the performing laboratory, or total bilirubin values more than or equal to 1.5 times the ULN of the performing laboratory at Visit 1.
[28]Patients not being treated with an antipsychotic drug known to elevate prolactin with a prolactin level more than 200 ng/mL; and patients presently treated with antipsychotic drugs (includin

Study & Design

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