Phase 4 N=202 Randomized Quadruple-blind Treatment

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

Bipolar I Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00402324 ↗

Enrolled (actual)

202

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint. — -10.15; -7.68 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: olanzapine (Drug); placebo (Drug); divalproex (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.	-10.15; -7.68	<0.001 sig
PRIMARY Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.	-9.37; -7.69	0.022 sig
SECONDARY Number of Participants Meeting the Criteria for Mixed Onset of Action	81; 71	0.100
SECONDARY Number of Participants Meeting the Criteria for Mixed Response	54; 40	0.048 sig
SECONDARY Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint	-1.34; -1.06	0.056
SECONDARY Number of Patients Hospitalized Due to Relapse of Mania or Depression.	1; 0	—
SECONDARY Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline	191.37; 192.25; -7.80; -8.72; 115.32; 111.01	0.657
SECONDARY Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline	111.46; 139.75; 22.91; 16.80	0.293
SECONDARY Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline	91.81; 91.90; 6.93; -0.55	0.007 sig
SECONDARY Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline	6.50; 6.65; -1.56; -0.74	0.046 sig
SECONDARY Clinically Significant Vital Signs - Body Mass Index Change From Baseline	1.18; 0.26	<0.001 sig
SECONDARY Clinically Significant Vital Signs - Weight Change From Baseline	3.34; 0.70	<0.001 sig
SECONDARY Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)	22; 3	<0.001 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00402324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.