A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

Bipolar I Disorder Clinical Trial

Official title:

A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402324
• Other study ID #: 10825
• Secondary ID: F1D-US-HGMO
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2006
• Last updated: May 28, 2009
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosed with a mixed episode of bipolar I disorder.

• Have had at least one previous manic or mixed episode associated with bipolar disorder

• You must be between 18 and 60 years old.

• You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.

• If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.

Exclusion Criteria:

• You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.

• You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.

• Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).

• You are allergic to any of the medications involved in this study.

Study Design

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• olanzapine
15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
• placebo
placebo, capsules, by mouth every evening, daily, for 6 weeks.
• divalproex
dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).

Locations

Country	Name	City	State
United States	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.	Hialeah	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.		Baseline to endpoint (6 weeks)	No
Primary	Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.		Baseline to endpoint (6 weeks)	No
Secondary	Number of Participants Meeting the Criteria for Mixed Onset of Action		Baseline to endpoint (6 weeks)	No
Secondary	Number of Participants Meeting the Criteria for Mixed Response		baseline to endpoint (6 weeks)	No
Secondary	Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint		Baseline to endpoint (6 weeks)	No
Secondary	Number of Patients Hospitalized Due to Relapse of Mania or Depression.		Baseline to endpoint (6 weeks)	No
Secondary	Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Vital Signs - Body Mass Index Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Vital Signs - Weight Change From Baseline		Baseline to endpoint (6 weeks)	Yes
Secondary	Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)		Baseline to endpoint (6 weeks)	Yes

External Links

•   Lilly Clinical Trial Registry