Bipolar DisorderPhase 3NCT00254774
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
A Phase 3 study testing quetiapine fumarate or valproate in people with Bipolar Disorder, run by AstraZeneca at 3 sites in Germany.
Trial summary
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling. 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?
- quetiapine fumarate or valproate
- How many people
- 44 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2002to Mar 2006
- Phase
- Phase 3
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
- Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling.
Who cannot join
- Substance or alcohol dependence, female patients who are pregnant, lactating or at risk of pregnancy, diagnosis of schizophrenia or borderline personality disorder or antisocial personality disorder, history of seizure disorder, acute suicidal or external aggressive behaviour, legal incapacity or indication for treatment against the will of the patient by law.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Research Site
Berlin
Research Site
Freiburg im Breisgau
Research Site
München
About this study
Official title: Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
- Conditions
- Bipolar Disorder
- Being tested
- quetiapine fumarate or valproate
- Keywords
- Bipolar Disorder I or II with Rapid Cycling
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine fumarate or valproateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps.
Secondary outcomes (1)
Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startJan 2002
- Study completionMar 2006
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 AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Germany Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254774
- Sponsor's protocol ID
- 5077/9061
- Other IDs
- D1441C09061
- Status last verified
- Dec 2007
- First submitted
- 15 Nov 2005
- Last updated
- 18 Dec 2007
- Results posted
- No