Bipolar DisorderPhase 2NCT00771134
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
A Phase 2 study testing Lu AA39959 and Quetiapine in people with Bipolar Disorder, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lu AA39959 and Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Aug 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
- Moderate to severe depression
- History of at least one documented mania or hypomania episode
- Absence of current mania or hypomania
Who cannot join
- Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
- Any substance disorder with the previous 6 months
- Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
- ECT within 6 months before the study
- Female of childbearing potential and not using adequate contraception
- Other protocol-defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Read the detailed description
Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.
Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Lu AA39959, Placebo, Quetiapine
- Keywords
- Depression, Bipolar I Disorder, Bipolar II Disorder, Placebo-controlled, Double-blind, Randomised controlled, Multicenter, Clinical study, Mania
- Medical subject headings
- Bipolar Disorder, Depression, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA39959Drug
30mg/day; 15mg B.I.D. for 8 weeks
PlaceboDrug
B.I.D. for 8 weeks
QuetiapineDrug
Also called Seroquel
300mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lu AA39959 | Experimental | Not described Receives: Drug: Lu AA39959 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Quetiapine | Active comparator | Not described Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms as measured by the change from baseline in total MADRS score
Measured: 8 weeks
Secondary outcomes (1)
Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: Study was previously suspended and is now terminated
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 H. Lundbeck A/SThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771134
- Sponsor's protocol ID
- 12601A
- Status last verified
- May 2014
- First submitted
- 10 Oct 2008
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder
- ClinicalTrials.gov ID
- NCT00771134
- Acronym / sponsor ID
- 12601A
- Conditions
- Bipolar Disorder
- Keywords
- Depression, Bipolar I Disorder, Bipolar II Disorder, Placebo-controlled, Double-blind, Randomised controlled, Multicenter, Clinical study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was previously suspended and is now terminated
- Enrolment
- 105 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 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.
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Detailed description
Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.
Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lu AA39959 | Experimental | Drug: Lu AA39959 |
| Placebo | Placebo comparator | Drug: Placebo |
| Quetiapine | Active comparator | Drug: Quetiapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
- Moderate to severe depression
- History of at least one documented mania or hypomania episode
- Absence of current mania or hypomania
Key exclusion criteria (6 listed)
- Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
- Any substance disorder with the previous 6 months
- Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
- ECT within 6 months before the study
- Female of childbearing potential and not using adequate contraception
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 |
|---|---|---|
| Lu AA3995930mg/day; 15mg B.I.D. for 8 weeks | Drug | Lu AA39959 |
| PlaceboB.I.D. for 8 weeks | Drug | Placebo |
| QuetiapineAlso: Seroquel300mg/day for 8 weeks | Drug | Quetiapine |
Primary outcome
Depressive symptoms as measured by the change from baseline in total MADRS score
Time frame: 8 weeks
1 secondary outcome
Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Study was previously suspended and is now terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AA39959 and Quetiapine in people with Bipolar Disorder, run by H. Lundbeck A/S 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 6 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 28 May 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study was previously suspended and is now terminated). 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?
Depressive symptoms as measured by the change from baseline in total MADRS score (time frame: 8 weeks). 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 28 May 2014.