Bipolar DisorderPhase 4NCT00050206
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
A Phase 4 study testing Olanzapine in people with Bipolar Disorder, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
- Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
- Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
Who cannot join
- Female patients who are either pregnant or nursing.
- Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
- Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
- Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
- Patients who have been judged clinically to be serious suicidal risks.
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 hrs, EST), or speak with your personal physician.
Indianapolis, Indiana
About this study
The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
- Conditions
- Bipolar Disorder
- Being tested
- Olanzapine, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
Secondary outcomes (4)
Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2002 (estimated)
- Study startNov 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 130 participants
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 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050206
- Sponsor's protocol ID
- 4360
- Other IDs
- F1D-MC-HGIU
- Status last verified
- Jun 2007
- First submitted
- 26 Nov 2002
- Last updated
- 12 Jun 2007
- Results posted
- No
Publications
Xiao L, Ganocy SJ, Findling RL, Chang K, DelBello MP, Kane JM, Tohen M, Xiang YT, Correll CU. Baseline Characteristics and Early Response at Week 1 Predict Treatment Outcome in Adolescents With Bipolar Manic or Mixed Episode Treated With Olanzapine: Results From a 3-Week, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1158-e1166. doi: 10.4088/JCP.16m10923.
PubMed 28922591Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. doi: 10.4088/jcp.08m03538. Epub 2009 Feb 10.
PubMed 19210948Tohen M, Kryzhanovskaya L, Carlson G, Delbello M, Wozniak J, Kowatch R, Wagner K, Findling R, Lin D, Robertson-Plouch C, Xu W, Dittmann RW, Biederman J. Olanzapine versus placebo in the treatment of adolescents with bipolar mania. Am J Psychiatry. 2007 Oct;164(10):1547-56. doi: 10.1176/appi.ajp.2007.06111932.
PubMed 17898346
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00050206
- Acronym / sponsor ID
- 4360
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- May 2005 (actual)
- First posted
- 27 Nov 2002 (estimated)
- Results
- Not posted in the source record
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 determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
- Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
- Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
Key exclusion criteria (5 listed)
- Female patients who are either pregnant or nursing.
- Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
- Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
- Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
- Patients who have been judged clinically to be serious suicidal risks.
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 |
|---|---|---|
| Olanzapine | Drug | – |
| Placebo | Drug | – |
Primary outcome
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
4 secondary outcomes
Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2007.
- Derived from this study: PubMed 28922591Xiao L, Ganocy SJ, Findling RL, Chang K, DelBello MP, Kane JM, Tohen M, Xiang YT, Correll CU. Baseline Characteristics and Early Response at Week 1 Predict Treatment Outcome in Adolescents With Bipolar Manic or Mixed Episode Treated With Olanzapine: Results From a 3-Week, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1158-e1166. doi: 10.4088/JCP.16m10923.
- Derived from this study: PubMed 19210948Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. doi: 10.4088/jcp.08m03538. Epub 2009 Feb 10.
- Derived from this study: PubMed 17898346Tohen M, Kryzhanovskaya L, Carlson G, Delbello M, Wozniak J, Kowatch R, Wagner K, Findling R, Lin D, Robertson-Plouch C, Xu W, Dittmann RW, Biederman J. Olanzapine versus placebo in the treatment of adolescents with bipolar mania. Am J Psychiatry. 2007 Oct;164(10):1547-56. doi: 10.1176/appi.ajp.2007.06111932.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine in people with Bipolar 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 4 inclusion and 5 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 12 Jun 2007. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents. 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 NCT00050206, which also lists 3 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 12 Jun 2007.