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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389908
Recruitment Status : Unknown
Verified June 2011 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Information provided by:
Shalvata Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorders Drug: olanzapine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : June 2011
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. blood pressure and pulse [ Time Frame: 10 minutes prior to the injection ]
    supine and standing blood pressure and pulse will be measured 10 minutes prior to the injection

  2. blood pressure and pulse [ Time Frame: 15 minutes following the injection ]
    supine and standing blood pressure and pulse will be measured 15 minutes following the injection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389908

Shalvata MHC Recruiting
Hod hasharon, Israel
Contact: Ziv Carmel, Dr.    972-9-7478403   
Principal Investigator: Ziv Carmel, Dr.         
Sponsors and Collaborators
Shalvata Mental Health Center

Responsible Party: Dr. Ziv Carmel, Shalvata MHC Identifier: NCT01389908     History of Changes
Other Study ID Numbers: sh-03-11
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents