Depression in Patients With Bipolar DisorderPhase 2NCT00622245
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
A Phase 2 study testing Lu AA34893 and Quetiapine fumarate in people with Depression in Patients With Bipolar Disorder, run by H. Lundbeck A/S at 50 sites in 18 countries.
Trial summary
This study will evaluate the efficacy and safety of different doses of Lu AA34893 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
- Depression in Patients With Bipolar Disorder
- What is being tested?
- Lu AA34893 and Quetiapine fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 50 sitesin 18 countries
- Study dates
- Jan 2008to Nov 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 I or bipolar II 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
50 sites in 18 countries.
50 sites in 18 countries
Lithuania5 sites
LT005
Kaunas, 50185
LT003
Kaunas Region, 53136
LT004
Klaipėda, 91251
LT001
Vilnius, 10204
LT002
Vilnius, 10204
Sweden5 sites
SE006
Halmstad, 302 27
SE003
Lund, 223 61
SE005
Malmö, 211 22
SE002
Sollentuna, 191 35
SE001
Stockholm, 112 34
France4 sites
FR001
Clermont-Ferrand, 63003
FR007
Orvault, 44700
FR004
Paris, 75571
FR002
Sartrouville, 78500
Romania4 sites
RO001
Arad, 310022
RO002
Bucharest, 41914
RO003
Cluj-Napoca, 400012
RO005
Craiova, 200260
South Korea4 sites
KR004
Inchon, 403-720
KR003
Jeonju, 561-712
KR005
Kyunggi-do, 431-720
KR002
Seoul, 110-744
Australia3 sites
AU001
Brisbane, 4000
AU003
Dandenong, 3175
AU002
Malvern, 3144
Canada3 sites
CA303
London, N6A 4H1
CA301
Montreal, H3M 3A9
CA302
Orléans, K1C 1E9
Germany3 sites
DE004
Berlin, 10245
DE003
Bochum, 44892
DE002
Gelsenkirchen, 45879
Malaysia3 sites
MY004
Klang, 43000
MY005
Kota Kinabalu, 88815
MY002
Kuala Lumpur, 59100
Philippines3 sites
PH002
Las Piñas, 1701
PH003
Mandaluyong
PH001
Mandaue City, 6014
About this study
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
Read the detailed description
Bipolar disorder is a common lifelong psychiatric disorder. It is 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 medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim.
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 AA34893, in treatment of depression in patients with bipolar disorder.
- Being tested
- Lu AA34893, Quetiapine fumarate, Placebo
- Keywords
- Depression, Bipolar disorder, Placebo-controlled, Double-blind, Multicenter, Clinical study, Mania
- Medical subject headings
- Depression, Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA34893Drug
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Quetiapine fumarateDrug
per oral, once daily, during 12 weeks, followed by a one-week tapering period
PlaceboDrug
per oral doses, twice daily as capsules during 13 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lu AA34893: 4 mg | Experimental | Not described Receives: Drug: Lu AA34893 |
| Lu AA34893: 12 mg | Experimental | Not described Receives: Drug: Lu AA34893 |
| Lu AA34893: 18 mg | Experimental | Not described Receives: Drug: Lu AA34893 |
| Quetiapine fumarate | Other | Active reference 300 mg Receives: Drug: Quetiapine fumarate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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)
HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionNov 2009
Why it stopped: Human metabolite not yet covered sufficiently by nonclinical data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Patients With 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622245
- Sponsor's protocol ID
- 12022A
- Other IDs
- 2007-002551-17
- Status last verified
- Sep 2010
- First submitted
- 12 Feb 2008
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder
- ClinicalTrials.gov ID
- NCT00622245
- Acronym / sponsor ID
- 12022A
- Keywords
- Depression, Bipolar disorder, Placebo-controlled, Double-blind, Multicenter, Clinical study, Mania
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Human metabolite not yet covered sufficiently by nonclinical data
- Enrolment
- 166 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Feb 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 different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
Detailed description
Bipolar disorder is a common lifelong psychiatric disorder. It is 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 medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim.
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 AA34893, 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Lu AA34893: 4 mg | Experimental | Drug: Lu AA34893 |
| Lu AA34893: 12 mg | Experimental | Drug: Lu AA34893 |
| Lu AA34893: 18 mg | Experimental | Drug: Lu AA34893 |
| Quetiapine fumarate | Other | Drug: Quetiapine fumarateActive reference 300 mg |
| Placebo | Placebo comparator | Drug: Placebo |
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 I or bipolar II 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 AA34893per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period | Drug | Lu AA34893: 12 mg, Lu AA34893: 18 mg, Lu AA34893: 4 mg |
| Quetiapine fumarateper oral, once daily, during 12 weeks, followed by a one-week tapering period | Drug | Quetiapine fumarate |
| Placeboper oral doses, twice daily as capsules during 13 weeks | Drug | Placebo |
Primary outcome
Depressive symptoms as measured by the change from baseline in total MADRS score
Time frame: 8 weeks
1 secondary outcome
HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Human metabolite not yet covered sufficiently by nonclinical data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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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
50 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AA34893 and Quetiapine fumarate in people with Depression in Patients With Bipolar Disorder, run by H. Lundbeck A/S at 50 sites in 18 countries.
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 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Lithuania, Sweden, France, Romania, South Korea and 13 more countries. 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: Human metabolite not yet covered sufficiently by nonclinical data). 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 27 Sep 2010.