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Olanzapine Treatment of Patients With Bipolar I Disorder

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression, Bipolar

Intervention: Olanzapine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5hrs, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.

Clinical Details

Official title: Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)

Secondary outcome:

Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)

Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)

Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)

Percentage of Participants With Recovery (Acute Phase)

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)

Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)

Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)

Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)

Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)

Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)

Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)

Percentage of Participants With Emergence of Mania During the Study (Acute Phase)

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)

Change From Baseline to Endpoint in Blood Pressure (Acute Phase)

Change From Baseline to Endpoint in Weight (Acute Phase)

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)

Change From Baseline to Endpoint in Albumin (Acute Phase)

Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)

Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)

Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)

Change From Baseline to Endpoint in Hematocrit (Acute Phase)

Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)

Change From Baseline to Endpoint in Hemoglobin (Acute Phase)

Change From Baseline to Endpoint in Prolactin (Acute Phase)

Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)

Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)

Change From Baseline to Endpoint in Heart Rate (Acute Phase)

Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)

Number of Participants With Adverse Events (Acute Phase)

Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)

Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)

Percentage of Participants With Recovery (Open-Label Phase)

Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)

Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)

Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)

Change From Baseline to Endpoint in Weight (Open-Label Phase)

Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)

Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)

Change From Baseline to Endpoint in Chloride (Open-Label Phase)

Change From Baseline to Endpoint in Creatinine (Open-Label Phase)

Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)

Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)

Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)

Change From Baseline to Endpoint in Prolactin (Open-Label Phase)

Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)

Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)

Change From Baseline to Endpoint in ECG (Open-Label Phase)

Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)

Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)

Number of Participants With Adverse Events (Open-Label Phase)

Detailed description:

1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day

2. Duration: 1. Screening phase is 2-28 days. 2. Double-blind treatment phase is 6 weeks 3. Open-label extension phase is 18 weeks

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Each patient must be reliable, have a level of understanding sufficient to perform

all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent

- All female patients must test negative for pregnancy and females of breast-feeding

potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug

- Patients must fulfill the criteria for a major depressive episode according to the

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry

- Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score

greater than or equal to 18 at Visit 1 and Visit 2

- Patients must have a current Young Mania Rating Scale (YMRS) total score less than or

equal to 8 at Visit 2. Exclusion Criteria:

- Has received treatment within the past 30 days with a drug (not including study drug)

that has not received regulatory approval for any indication at the time of study entry

- Has participated in a clinical trial of another investigational drug, including

olanzapine, within 1 month (30 days) before study entry

- Was previously treated with olanzapine and had bipolar depression considered to be

treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI)

- Is experiencing (at the time of study entry) a current episode of bipolar depression

that is greater than 90 days in duration

- Has been treatment-resistant to any therapy prescribed for bipolar depression when

olanzapine alone or with an SSRI prescribed at an appropriate dose and duration

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beijing 100088, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Changsha 410008, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chengdu 610041, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Guang Zhou 510370, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hangzhou 310003, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Harbin 150001, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kunming 650032, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nanjing 210029, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Shanghai 200030, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wu Han 430060, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Xi'An 710032, China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hiroshima 731-0501, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Shiga 525-0037, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo 170-0002, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seongnam-Si 463-707, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seoul 110-744, Korea, Republic of

Additional Information

Starting date: August 2007
Last updated: April 26, 2011

Page last updated: August 23, 2015

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