Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00100776

Purpose

The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Olanzapine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.

Secondary Outcome Measures:

To assess the dose response efficacy of olanzapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS subscores and Clinical Global Impression-Severity(CGI-S) Scale as well as by the absolute score
of CGI-I (Improvement) Scale
To assess the efficacy of olanzapine doses between treatment arms (e.g. 10 mg/day versus 40 mg/day ) in improving the psychopathology of schizophrenia as measured by mean changed from baseline on the PANSS total and subscores and Clinical Global
Impression-Severity (CGI-S) Scale as well as by absolute score of CGI-I (Improvement) Scale
To assess the efficacy of olanzapine doses as measured by efficacy scales in patients who have successfully completed the 2 week titration period
To assess the efficacy of olanzapine doses within the standard range of 10 and 20 mg/day versus high dose 40 mg/day in improving the psychopathology of schizophrenia as measured by mean change from baseline on the PANSS total
To assess the response rate of olanzapine doses in improving the psychopathology of schizophrenia. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score
To compare the time to response among all olanzapine treatment arms. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score. In addition, the cumulative frequency distribution of differential
rates of response reduction in PANSS total score will be assessed at 8 weeks
To compare the dose response efficacy between all olanzapine treatment arms in improving depressive symptoms as measured by a mean change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)
To assess the efficacy between all olanzapine treatment arms in improving patients' overall level of functioning and health-related quality of life as measured by the Global assessment of Functioning (GAF) and the Heinrich Carpenter
Quality of Life Scale (QLS)
To analyze steady-state olanzapine plasma concentrations following 10, 20, and 40 mg daily dosing and examine the associations between state plasma levels, efficacy, and safety measures
To assess the safety between treatment arms and the safety dose-response relationship between the olanzapine treatment groups as determined by:
Treatment-emergent adverse events,
ECG
Vital signs and fasting laboratory analytes (clinical chemistry, hematology, lipid panel, and prolactin)
Appetite as measured by the Eating Behavior Assessment
Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, The Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)

Estimated Enrollment:	600
Study Start Date:	September 2003
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You must be 18 to 60 years old
You must have been diagnosed with schizophrenia or schizoaffective disorder
You must be able to visit the doctor's office 8 times over a 9 week period
You must agree to participate with all tests and examinations that are required for this study

Exclusion Criteria:

You are a woman and are pregnant or breastfeeding
You presently have an acute or unstable medical illness
You have a history of an allergic reaction to olanzapine
You are taking medications that are not permitted in this study. Your physician will discuss these with you
You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100776

Show 33 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lindenmayer JP, Liu-Seifert H, Kulkarni PM, Kinon BJ, Stauffer V, Edwards SE, Chen L, Adams DH, Ascher-Svanum H, Buckley PF, Citrome L, Volavka J. Medication nonadherence and treatment outcome in patients with schizophrenia or schizoaffective disorder with suboptimal prior response. J Clin Psychiatry. 2009 Jul;70(7):990-6. Epub 2009 Jun 2.

Citrome L, Stauffer VL, Chen L, Kinon BJ, Kurtz DL, Jacobson JG, Bergstrom RF. Olanzapine plasma concentrations after treatment with 10, 20, and 40 mg/d in patients with schizophrenia: an analysis of correlations with efficacy, weight gain, and prolactin concentration. J Clin Psychopharmacol. 2009 Jun;29(3):278-83.

ClinicalTrials.gov Identifier:	NCT00100776 History of Changes
Other Study ID Numbers:	8333, F1D-US-HGLF
Study First Received:	January 6, 2005
Last Updated:	January 24, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012