Bipolar DisorderPhase 4NCT00767715
A Study in the Treatment of Acute Mania
A Phase 4 study testing olanzapine, haloperidol and zuclopentixol in people with Bipolar Disorder, run by Eli Lilly and Company at 1 site in Sweden.
Trial summary
The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- olanzapine, haloperidol and zuclopentixol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2004to Apr 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
- Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
- Patients must have experienced at least one manic or mixed episode prior to study enrollment
- Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
- Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
- Patients must be considered reliable
- Each patient must understand the nature of the study and signed informed consent
Who cannot join
- Female patients who are pregnant or lactating
- Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
- History of allergic reactions or intolerance to study medications
- DSM-IV substance dependence within the past 30 days at the judgement of the investigator
Show all 10Show fewer
- Judged clinically to be at serious suicidal risk
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2
- Any patient treated with clozapine within 4 weeks prior to visit 2
- Subjects who have received treatment with ECT within one month prior to visit 1
Trial locations and contacts
1 site in 1 country.
Sweden1 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.
Danderyd
About this study
Official title: A Randomized Open Label Study on the Efficacy, Tolerability, and Total Costs of Olanzapine Versus Conventional Antipsychotics in the Treatment of Acute Mania in Sweden
The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
Read the detailed description
The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary efficacy measure. Remission is defined as a Y-MRS score <=12 AND a MADRS-S score <=12 AND CGI-BP = 1 or 2.
Secondary efficacy assessments will include time from baseline to
- Response, as defined as a reduction of Y-MRS score greater than or equal to 50% compared to baseline
- Relapse of mania, as defined as a Y-MRS score >= 16 AND CGI-BP >2 after having met the criteria for remission
- Switch into depression, as defined as a MADRS-S score >=17 AND fulfilled criteria for Major Depression as self-assessed by DSRS.
- Conditions
- Bipolar Disorder
- Being tested
- olanzapine, haloperidol, zuclopentixol
- 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
Also called LY170053, Zyprexa
physician determined dose, oral, daily, 5 months
haloperidolDrug
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
zuclopentixolDrug
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients will be given olanzapine Receives: Drug: olanzapine |
| B | Active comparator | Patients will be given either haloperidol or zuclopentixol Receives: Drug: haloperidol; Drug: zuclopentixol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
Measured: 5 months
Secondary outcomes (11)
Resource utilization Clinical Report Form (RUCRF)
Measured: 5 months
Disability free day assessment (DFDA)
Measured: 5 months
Medication compliance
Measured: 5 months
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Measured: 5 months
Euro Qol instrument
Measured: 5 months
Drug Attitude Inventory (DAI)
Measured: 5 months
Response by Y-MRS
Measured: 5 months
Frequency of and time to relapse into mania by Y-MRS and CGI-BP
Measured: 5 months
Frequency of and time to switch to depression by MADRS-S and DSRS
Measured: 5 months
Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum
Measured: 5 months
Adverse events
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2004
- Primary completionApr 2005
- Study completionApr 2005
Why it stopped: Trial discontinued due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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 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
- NCT00767715
- Sponsor's protocol ID
- 7313
- Other IDs
- F1D-SO-HGLY
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Study on the Efficacy, Tolerability, and Total Costs of Olanzapine Versus Conventional Antipsychotics in the Treatment of Acute Mania in Sweden
- ClinicalTrials.gov ID
- NCT00767715
- Acronym / sponsor ID
- 7313
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial discontinued due to low enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 7 Oct 2008 (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 test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
Detailed description
The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary efficacy measure. Remission is defined as a Y-MRS score <=12 AND a MADRS-S score <=12 AND CGI-BP = 1 or 2.
Secondary efficacy assessments will include time from baseline to
- Response, as defined as a reduction of Y-MRS score greater than or equal to 50% compared to baseline
- Relapse of mania, as defined as a Y-MRS score >= 16 AND CGI-BP >2 after having met the criteria for remission
- Switch into depression, as defined as a MADRS-S score >=17 AND fulfilled criteria for Major Depression as self-assessed by DSRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: olanzapinePatients will be given olanzapine |
| B | Active comparator | Drug: haloperidol, Drug: zuclopentixolPatients will be given either haloperidol or zuclopentixol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
- Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
- Patients must have experienced at least one manic or mixed episode prior to study enrollment
- Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
- Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
Key exclusion criteria (10 listed)
- Female patients who are pregnant or lactating
- Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
- History of allergic reactions or intolerance to study medications
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, Zyprexaphysician determined dose, oral, daily, 5 months | Drug | A |
| haloperidolphysician determined dose, oral, parenteral (<= 3 days), daily, 5 months | Drug | B |
| zuclopentixolphysician determined dose, oral, parenteral (<= 3 days), daily, 5 months | Drug | B |
Primary outcome
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
Time frame: 5 months
11 secondary outcomes
Resource utilization Clinical Report Form (RUCRF)
Time frame: 5 months
Disability free day assessment (DFDA)
Time frame: 5 months
Medication compliance
Time frame: 5 months
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: 5 months
Euro Qol instrument
Time frame: 5 months
Drug Attitude Inventory (DAI)
Time frame: 5 months
Response by Y-MRS
Time frame: 5 months
Frequency of and time to relapse into mania by Y-MRS and CGI-BP
Time frame: 5 months
Frequency of and time to switch to depression by MADRS-S and DSRS
Time frame: 5 months
Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum
Time frame: 5 months
Adverse events
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Trial discontinued due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2008.
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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, haloperidol and zuclopentixol in people with Bipolar Disorder, run by Eli Lilly and Company at 1 site in Sweden.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Oct 2008. 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 Sweden. 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 was stopped early (reason given: Trial discontinued due to low enrollment). Results are not available in the source record.
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?
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2008; AzTrials last refreshed its copy on 7 Nov 2026.