A Follow up Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizoaffective Disorders
• Intervention / Treatment: Drug: olanzapine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hod hasharon, Israel
    • Recruiting
    • Shalvata MHC
    • Contact: Ziv Carmel, Dr.; Phone Number: 972-9-7478403; Email: zivca@clalit.org.il
    • Principal Investigator: Ziv Carmel, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Two patients that have been stabilized on OP Depot will be enrolled to the follow-up study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: schizophrenia; schizophrenia or schizoaffective patients	Drug: olanzapine; Patients will receive doses within the range of 280 mg to 405mg OP Depot, according the physician's judgment, on a 3-week interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure and pulse	supine and standing blood pressure and pulse will be measured 10 minutes prior to the injection	10 minutes prior to the injection
blood pressure and pulse	supine and standing blood pressure and pulse will be measured 15 minutes following the injection	15 minutes following the injection

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: sh-03-11