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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00402324
First received: November 17, 2006
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Bipolar I Disorder
Drug: olanzapine
Drug: placebo
Drug: divalproex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint. [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]
  • Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint. [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Meeting the Criteria for Mixed Onset of Action [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]
  • Number of Participants Meeting the Criteria for Mixed Response [ Time Frame: baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]
  • Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]
  • Number of Patients Hospitalized Due to Relapse of Mania or Depression. [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: No ]
  • Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Vital Signs - Body Mass Index Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Vital Signs - Weight Change From Baseline [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]
  • Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%) [ Time Frame: Baseline to endpoint (6 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 202
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olanzapine and divalproex
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).
Other Names:
  • LY170053
  • Zyprexa
Drug: 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).
Placebo Comparator: 2
placebo and divalproex
Drug: placebo
placebo, capsules, by mouth every evening, daily, for 6 weeks.
Drug: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402324

Locations
United States, Florida
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, United States, 33016
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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00402324     History of Changes
Other Study ID Numbers: 10825, F1D-US-HGMO
Study First Received: November 17, 2006
Results First Received: February 13, 2009
Last Updated: May 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Mixed episode associated with Bipolar I

Additional relevant MeSH terms:
Valproic Acid
Olanzapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on August 18, 2014