Bipolar DisorderPhase 3NCT00129220
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
A Phase 3 study testing olanzapine and haloperidol in people with Bipolar Disorder, run by Eli Lilly and Company at 16 sites in Japan.
Trial summary
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- olanzapine and haloperidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 16 sitesJapan
- Study dates
- Jul 2005to Jan 2009
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
- Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
Who cannot join
- Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
- The duration of the current episode is more than 90 days at Visit 1.
- Have a history or a diagnosis of diabetes mellitus.
- Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
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.
Aichi, 470-1168
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Akita, 010-1654
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Chiba, 283-0062
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Fukuoka, 807-8555
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Gunma, 370-2455
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Hokkaido, 004-0841
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Hyōgo, 663-8501
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Kanagawa, 236-0037
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Kumamoto, 861-0002
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Nagano, 384-8540
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Okayama, 700-8558
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Okinawa, 904-2222
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Osaka, 561-0803
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Saga, 842-0192
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Saitama, 343-0032
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, 160-0023
About this study
Official title: Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
- Conditions
- Bipolar Disorder
- Being tested
- olanzapine, haloperidol, placebo
- Keywords
- Manic or mixed episode associated with bipolar I disorder
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called LY170053, Zyprexa
5-20 mg, oral, once daily (evening), for 6 weeks
haloperidolDrug
2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
placeboDrug
placebo, oral tablets, twice daily (morning and evening), for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | olanzapine: 5 to 20 mg per day for 6 weeks Receives: Drug: olanzapine |
| Haloperidol | Active comparator | haloperidol: 2.5 to 10 mg per day for 6 weeks Receives: Drug: haloperidol |
| Placebo | Placebo comparator | placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
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, 3 weeks
Secondary outcomes (10)
Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)
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, 6 weeks
Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)
Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
Measured: 6 weeks
Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness
A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline, 6 weeks
Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline, 3 weeks, 6 weeks
Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. 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. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.
Measured: Baseline, 3 weeks, 6 weeks
Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
Measured: 3 weeks, 6 weeks
Percentage of Participants Who Switched to Symptomatic Depression
Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Measured: 3 weeks, 6 weeks
Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.
Measured: Baseline, 3 weeks, 6 weeks
Percentage of Participants Who Switched to Syndromic Depression
Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).
Measured: 3 weeks, 6 weeks
Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129220
- Sponsor's protocol ID
- 9636
- Other IDs
- F1D-JE-BMAC
- Status last verified
- Dec 2010
- First submitted
- 8 Aug 2005
- Last updated
- 28 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Katagiri H, Takita Y, Tohen M, Higuchi T, Kanba S, Takahashi M. Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. J Affect Disord. 2012 Feb;136(3):476-84. doi: 10.1016/j.jad.2011.10.045. Epub 2011 Nov 30.
PubMed 22134043
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00129220
- Acronym / sponsor ID
- 9636
- Conditions
- Bipolar Disorder
- Keywords
- Manic or mixed episode associated with bipolar I disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 15 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: olanzapineolanzapine: 5 to 20 mg per day for 6 weeks |
| Haloperidol | Active comparator | Drug: haloperidolhaloperidol: 2.5 to 10 mg per day for 6 weeks |
| Placebo | Placebo comparator | Drug: placeboplacebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
- Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
Key exclusion criteria (4 listed)
- Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
- The duration of the current episode is more than 90 days at Visit 1.
- Have a history or a diagnosis of diabetes mellitus.
- Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapineAlso: LY170053, Zyprexa5-20 mg, oral, once daily (evening), for 6 weeks | Drug | Olanzapine |
| haloperidol2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks. | Drug | Haloperidol |
| placeboplacebo, oral tablets, twice daily (morning and evening), for 3 weeks | Drug | Placebo |
Primary outcome
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline, 3 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.
10 secondary outcomes
Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)
Time frame: Baseline, 6 weeks
Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)
Time frame: 6 weeks
Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness
Time frame: Baseline, 6 weeks
Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
Time frame: Baseline, 3 weeks, 6 weeks
Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Time frame: Baseline, 3 weeks, 6 weeks
Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Time frame: 3 weeks, 6 weeks
Percentage of Participants Who Switched to Symptomatic Depression
Time frame: 3 weeks, 6 weeks
Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 3 weeks, 6 weeks
Percentage of Participants Who Switched to Syndromic Depression
Time frame: 3 weeks, 6 weeks
Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22134043Katagiri H, Takita Y, Tohen M, Higuchi T, Kanba S, Takahashi M. Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. J Affect Disord. 2012 Feb;136(3):476-84. doi: 10.1016/j.jad.2011.10.045. Epub 2011 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olanzapine and haloperidol in people with Bipolar Disorder, run by Eli Lilly and Company at 16 sites in Japan.
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 2 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Feb 2010). 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?
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score (time frame: Baseline, 3 weeks). 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 NCT00129220, which also lists 1 linked publication.
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 28 Dec 2010.