Clinical trial NCT00402324: A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Official title: A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar I Disorder
Keywords: Mixed episode associated with Bipolar I
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
timeFrame: Baseline to endpoint (6 weeks)
measure: Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.
timeFrame: Baseline to endpoint (6 weeks)
Secondary outcomes:
measure: Number of Participants Meeting the Criteria for Mixed Onset of Action
timeFrame: Baseline to endpoint (6 weeks)
measure: Number of Participants Meeting the Criteria for Mixed Response
timeFrame: baseline to endpoint (6 weeks)
measure: Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint
timeFrame: Baseline to endpoint (6 weeks)
measure: Number of Patients Hospitalized Due to Relapse of Mania or Depression.
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Vital Signs - Body Mass Index Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Vital Signs - Weight Change From Baseline
timeFrame: Baseline to endpoint (6 weeks)
measure: Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)
timeFrame: Baseline to endpoint (6 weeks)
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: 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.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Houston JP, Gatz JL, Degenhardt EK, Jamal HH. Symptoms predicting remission after divalproex augmentation with olanzapine in partially nonresponsive patients experiencing mixed bipolar I episode: a post-hoc analysis of a randomized controlled study. BMC Res Notes. 2010 Nov 2;3:276. doi: 10.1186/1756-0500-3-276.
citation: Houston JP, Tohen M, Degenhardt EK, Jamal HH, Liu LL, Ketter TA. Olanzapine-divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Nov;70(11):1540-7. doi: 10.4088/JCP.08m04895yel. Epub 2009 Sep 22.