Bipolar DisorderPhase 4NCT00139074
Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
A Phase 4 study testing Quetiapine fumarate and sodium valproate in people with Bipolar Disorder, run by AstraZeneca at 7 sites in Denmark.
Trial summary
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Quetiapine fumarate and sodium valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesDenmark
- Study dates
- Jul 2005to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from a manic or mixed episode.
Who cannot join
- Patients who have not provided personal informed consent,
- Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
- Involuntary admittance/detainment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Research Site
Copenhagen
Research Site
Esbjerg
Research Site
Frederikssund
Research Site
Haderslev
Research Site
Hellerup
Research Site
Kolding
Researcg Site
Svendborg
About this study
Official title: Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Bipolar Disorder
- Being tested
- Quetiapine fumarate, sodium valproate
- Keywords
- Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
- 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 fumarateDrug
Also called Seroquel
oral variable dose
sodium valproateDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | quetiapine fumarate monotherapy Receives: Drug: Quetiapine fumarate |
| 2 | Experimental | Quetiapine + sodium valproate Receives: Drug: Quetiapine fumarate; Drug: sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
Measured: after 2 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: terminated due to very low recruitment rate (27 June 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Rasmus Wenzer Licht, Principal investigator, AstraZenecaAstraZeneca Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139074
- Sponsor's protocol ID
- D1449L00010
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2005
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
- ClinicalTrials.gov ID
- NCT00139074
- Acronym / sponsor ID
- D1449L00010
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to very low recruitment rate (27 June 2006)
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 31 Aug 2005 (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 primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Quetiapine fumaratequetiapine fumarate monotherapy |
| 2 | Experimental | Drug: Quetiapine fumarate, Drug: sodium valproateQuetiapine + sodium valproate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from a manic or mixed episode.
Key exclusion criteria (3 listed)
- Patients who have not provided personal informed consent,
- Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
- Involuntary admittance/detainment.
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 |
|---|---|---|
| Quetiapine fumarateAlso: Seroqueloral variable dose | Drug | 1, 2 |
| sodium valproateoral | Drug | 2 |
Primary outcome
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
Time frame: after 2 weeks treatment
Results and safety
The study was stopped early (reason given: terminated due to very low recruitment rate (27 June 2006)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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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.
Dr. Rasmus Wenzer Licht principal investigator
AstraZeneca
AstraZeneca Seroquel Medical Science Director, MD study director
AstraZeneca
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine fumarate and sodium valproate in people with Bipolar Disorder, run by AstraZeneca at 7 sites in Denmark.
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 1 inclusion and 3 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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: terminated due to very low recruitment rate (27 June 2006)). 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?
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) (time frame: after 2 weeks treatment). 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 Jan 2013.