TerminatedPhase 2

Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Stopped: Study was previously suspended and is now terminated

United States105 participantsStarted 2008-12

Plain-language summary

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depressive symptoms as measured by the change from baseline in total MADRS score

Timeframe: 8 weeks

Trial details

NCT IDNCT00771134

SponsorH. Lundbeck A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Bipolar Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.