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OpenTrials
Completed

NCT Number: NCT00402324

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

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.

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, 33016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olanzapine

Drug

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

Placebo

Drug

placebo, capsules, by mouth every evening, daily, for 6 weeks.

divalproex

Drug

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).

Primary outcomes

  1. Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.

    Time frame: Baseline to endpoint (6 weeks)

    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  2. Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.

    Time frame: Baseline to endpoint (6 weeks)

    The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.

Secondary outcomes

  1. Number of Participants Meeting the Criteria for Mixed Onset of Action

    Time frame: Baseline to endpoint (6 weeks)

    The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.

  2. Number of Participants Meeting the Criteria for Mixed Response

    Time frame: baseline to endpoint (6 weeks)

    The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.

  3. Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint

    Time frame: Baseline to endpoint (6 weeks)

    CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  4. Number of Patients Hospitalized Due to Relapse of Mania or Depression.

    Time frame: Baseline to endpoint (6 weeks)

    Number of participants hospitalized as a result of relapse of mania or depression.

  5. Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.

  6. Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.

  7. Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.

  8. Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.

  9. Clinically Significant Vital Signs - Body Mass Index Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.

  10. Clinically Significant Vital Signs - Weight Change From Baseline

    Time frame: Baseline to endpoint (6 weeks)

    Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.

  11. 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)

    Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2006
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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