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Olanzapine Treatment of Patients With Bipolar I Disorder
This study is ongoing, but not recruiting participants.
First Received: July 30, 2007   Last Updated: January 8, 2010   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00510146
  Purpose

The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.


Condition Intervention Phase
Depression, Bipolar
 Drug: Olanzapine
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo

Resource links provided by NLM:

MedlinePlus related topics: Depression
Drug Information available for: Olanzapine
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess whether olanzapine is superior to placebo in patients with bipolar depression based on improvements in overall symptomatology, measured by the mean change in the Montgomery-Åsberg Depression Rating Scale total score. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess olanzapine compared with placebo in terms of rate of response. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of remission of depression. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of improvement in clinical symptomatology, based on reductions from baseline in scores of the Clinical Global Impressions-Bipolar Version Severity of Illness scale. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the rate of recovery, defined as a reduction in the Montgomery-Åsberg Depression Rating Scale total score for at least 4 weeks of treatment (post-baseline) and completion of the double-blind treatment. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the improvement in clinical symptomology, based on the reductions of scores from baseline on the Young Mania Rating Scale. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the improvement in clinical symptomatology, based on reductions from baseline in the Hamilton Depression Rating Scale-17 items scores. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms the presence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview major depressive episode (or major depressive episode with melancholic features) module. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the presence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview manic episode module. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the presence or absence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview psychotic disorders module. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in Mini International Neuropsychiatric Interview alcohol dependence/abuse module. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the presence or absence of specific syndromic criteria, assessed by the Mini International Neuropsychiatric Interview substance dependence/abuse module. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: No ]
  • Assess olanzapine compared with placebo in terms of the emergence of mania, defined as an increase in the Young Mania Rating Scale total score. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of the incidence and severity of extrapyramidal symptoms as measured by the Drug-Induced Extrapyramidal Symptoms Scale. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of safety as measured by treatment-emergent adverse events. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of safety as measured by changes in vital signs. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of safety as measured by changes in laboratory analytes. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of safety as measured by changes in Electrocardiograms. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess olanzapine compared with placebo in terms of suicidality or serious suicide risk, as determined by an investigator's clinical judgement or increase on the suicidality module of the Mini International Neuropsychiatric Interview. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of the rate of response with response defined as a reduction (from baseline to endpoint) of 50% or more in the Montgomery-Åsberg Depression Rating Scale total score. [ Time Frame: 14 weeks (open-label extension period) ] [ Designated as safety issue: No ]
  • Assess open-label olanzapine in terms of the rate of remission of depression as defined as a score of less than or equal to 12 in the Montgomery-Åsberg Depression Rating Scale total score. [ Time Frame: 14 weeks (open-label extension period) ] [ Designated as safety issue: No ]
  • Assess open-label olanzapine in terms of the rate of recovery as defined as a value of less than or equal to 12 in the Montgomery-Åsberg Depression Rating Scale total score for at least 4 weeks of treatment (post-baseline). [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: No ]
  • Assess open-label olanzapine in terms of the rate of improvement in clinical symptomatology, based on reductions of Young Mania Rating Scale scale scores from baseline. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: No ]
  • Assess open-label olanzapine in terms of the rate of emergence of mania, defined as a Young Mania Rating Scale total score greater than or equal to 15. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of the rate of the incidence and severity of extra-pyramidal symptoms as measured by the Drug-Induced Extrapyramidal Symptoms Scale. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of safety, as measured by Treatment Emergent Adverse Events. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of safety, as measured by change in vital signs. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of safety as measured by electrocardiograms. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]
  • Assess open-label olanzapine in terms of suicidality rate or serious suicide risk, determined by an investigator's clinical judgement or by a score greater than or equal to 17 on the Mini International Neuropsychiatric Interview suicidality module. [ Time Frame: 14 weeks (open-label extension) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 510
Study Start Date: August 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
olanzapine, double-blind treatment
Drug: Olanzapine
5-20 mg, oral, once daily, for 24 weeks (pts randomized to olanzapine in SPII) or 18 weeks (pts randomized to placebo in SPII).
2: Placebo Comparator
Placebo, double-blind treatment
Drug: Placebo
placebo tablets, oral, once daily at bedtime, 6 weeks
3: Experimental
Olanzapine, open label extension
Drug: Olanzapine
5-20 mg, oral, once daily, for 24 weeks (pts randomized to olanzapine in SPII) or 18 weeks (pts randomized to placebo in SPII).

Detailed Description:
  1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day

  2. Duration:

    1. Screening phase is 2-28 days.
    2. Double-blind treatment phase is 6 weeks
    3. Open-label extension phase is 18 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent
  • All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
  • Patients must fulfill the criteria for a major depressive episode according to the DSM-IV-TR as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the MINI, at study entry
  • Patients must have a current HAMD-17 score greater than or equal to 18 at V1 and V2
  • Patients must have a current YMRS total score less than or equal to 8 at V2.

Exclusion Criteria:

  • Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
  • Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry
  • Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available SSRI
  • Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration
  • Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI was prescribed at an appropriate dose and duration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510146

Locations
China
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.
Beijing, China, 100088
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.
Changsha, China, 410008
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.
Chengdu, China, 610041
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.
Guang Zhou, China, 510370
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.
Nanjing, China, 210029
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.
Harbin, China, 150001
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.
Kunming, China, 650032
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.
Hangzhou, China, 310003
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.
Shanghai, China, 200030
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.
Wu Han, China, 430060
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.
Xi'An, China, 710032
Japan
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.
Hiroshima, Japan, 731-0501
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.
Shiga, Japan, 525-0037
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.
Tokyo, Japan, 170-0002
Korea, Republic of
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.
Seongnam-Si, Korea, Republic of, 463-707
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.
Seoul, Korea, Republic of, 110-744
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 - 5 PM Eastern Time (UTC/GMT - 5hrs, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11218, F1D-MC-HGMP
Study First Received: July 30, 2007
Last Updated: January 8, 2010
ClinicalTrials.gov Identifier: NCT00510146     History of Changes
Health Authority: United States: Food and Drug Administration;   Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Depressants
 Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010



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