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Bipolar I DisorderPhase 4NCT00402324

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

A Phase 4 study testing olanzapine and divalproex in people with Bipolar I Disorder, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Bipolar I Disorder
What is being tested?
olanzapine and divalproex
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
1 siteUnited States
Study dates
Dec 2006to Feb 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • 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

Other trials in United States

About this study

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

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.

Being tested
olanzapine, placebo, divalproex
Keywords
Mixed episode associated with Bipolar I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olanzapineDrug

    Also called LY170053, Zyprexa

    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).

  • placeboDrug

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

  • divalproexDrug

    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).

Study groups in NCT00402324
Study groupRoleWhat they receive
1Experimentalolanzapine and divalproex
Receives: Drug: olanzapine; Drug: divalproex
2Placebo comparatorplacebo and divalproex
Receives: Drug: placebo; Drug: divalproex

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to endpoint (6 weeks)

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

    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.

    Measured: Baseline to endpoint (6 weeks)

Secondary outcomes (11)

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

    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.

    Measured: Baseline to endpoint (6 weeks)

  2. Number of Participants Meeting the Criteria for Mixed Response

    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.

    Measured: baseline to endpoint (6 weeks)

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

    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).

    Measured: Baseline to endpoint (6 weeks)

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

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

    Measured: Baseline to endpoint (6 weeks)

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

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

    Measured: Baseline to endpoint (6 weeks)

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

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

    Measured: Baseline to endpoint (6 weeks)

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

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

    Measured: Baseline to endpoint (6 weeks)

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

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

    Measured: Baseline to endpoint (6 weeks)

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

    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.

    Measured: Baseline to endpoint (6 weeks)

  10. Clinically Significant Vital Signs - Weight Change From Baseline

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

    Measured: Baseline to endpoint (6 weeks)

  11. Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)

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

    Measured: Baseline to endpoint (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402324
Sponsor's protocol ID
10825
Other IDs
F1D-US-HGMO
Status last verified
May 2009
First submitted
17 Nov 2006
Last updated
3 Jun 2009

Publications

  • 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.

    PubMed 21044339

  • 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.

    PubMed 19778495

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olanzapine and divalproex in people with Bipolar I Disorder, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint. (time frame: Baseline to endpoint (6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402324, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.

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