Bipolar DisorderPhase 3SPaRCLeNCT00314184
Quetiapine Fumarate Bipolar Maintenance Monotherapy
A Phase 3 study testing quetiapine fumarate in people with Bipolar Disorder, run by AstraZeneca at 95 sites in 15 countries.
Trial summary
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. 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
- How many people
- 1,255 participants
- Where
- 95 sitesin 15 countries
- Study dates
- Mar 2005to Jul 2007
- Phase
- Phase 3
- 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
- Signed informed consent
- 18 years or older
- A diagnosis of Bipolar I Disorder
- Have a current manic, depressed or mixed episode
- Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
- Female patients of childbearing potential must be using a reliable method of contraception
Who cannot join
- Pregnancy
- Substance or alcohol dependence at enrollment
- Unstable thyroid function
- Unstable Diabetes
- Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
- Use of an experimental drug within 30 days of enrollment
Trial locations and contacts
95 sites in 15 countries.
95 sites in 15 countries
United States30 sites
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Bellevue, Washington
Research Site
Cerritos, California
Research Site
Clementon, New Jersey
Research Site
Eagle, Idaho
Research Site
Fargo, North Dakota
Research Site
Flowood, Mississippi
Research Site
Gainesville, Florida
Research Site
Hoffman Estates, Illinois
Research Site
Jacksonville, Florida
Research Site
Kirkland, Washington
Research Site
Lake Jackson, Texas
Research Site
Las Vegas, Nevada
Research Site
Memphis, Tennessee
Research Site
North Miami, Florida
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Richmond, Virginia
Research Site
Rochester, New York
Research Site
Saint Charles, Missouri
Research Site
Salem, Oregon
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Seattle, Washington
Research Site
Shreveport, Louisiana
Research Site
Terre Haute, Indiana
Research Site
Washington D.C., District of Columbia
Romania12 sites
Research Site
Arad
Research Site
Brasov
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Com Jebel
Research Site
Craiova
Research Site
Iași
Research Site
Oradea
Research Site
Piteşti
Research Site
Sibiu
Research Site
Targoviste
Research Site
Târgu Mureş
India10 sites
Research Site
Ahmedabad
Research Site
Chennai
Research Site
Jaipur
Research Site
Kanpur
Research Site
Lucknow
Research Site
Mangalore
Research Site
Manipal
Research Site
Mumbai
Research Site
New Delhi
Research Site
Visakhapatnam
Ukraine8 sites
Research Site
Dnipro
Research Site
Kharkiv
Research Site
Kiev
Research Site
Kyiv
Research Site
Lviv
Research Site
Odesa
Research Site
Simferopol
Research Site
Vinnitsa
Argentina6 sites
Research Site
Capital Federal
Research Site
Córdoba
Research Site
La Plata
Research Site
Lanus
Research Site
Mendoza
Research Site
Rosario
Philippines5 sites
Research Site
Cebu City
Research Site
Davao City
Research Site
Mandaluyong
Research Site
Manila
Research Site
Quezon City
Colombia4 sites
Research Site
Antioquia
Research Site
Barranquilla
Research Site
Bogotá
Research Site
Pereira
Taiwan4 sites
Research Site
Kaohsiung Hsien
Research Site
Taipei
Research Site
Taoyuan City
Research Site
Taoyuan Hsien
Lithuania3 sites
Research Site
Kaunas
Research Site
Klaipėda
Research Site
Vilnius
Mexico3 sites
Research Site
León
Research Site
México
Research Site
San Luis Potosí City
Russia3 sites
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
About this study
Official title: Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.
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
- Keywords
- Bipolar I disorder.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to recurrence of a mood event
Secondary outcomes (2)
Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startMar 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca CNS Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314184
- Sponsor's protocol ID
- D1447C00144
- Other IDs
- EUDRACT 2004-000915-25
- Acronym
- SPaRCLe
- Status last verified
- Dec 2008
- First submitted
- 11 Apr 2006
- Last updated
- 22 Dec 2008
- Results posted
- No
Publications
Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.
PubMed 22054050
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
- ClinicalTrials.gov ID
- NCT00314184
- Acronym / sponsor ID
- SPaRCLe / D1447C00144
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I disorder.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Apr 2006 (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 is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.
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)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- 18 years or older
- A diagnosis of Bipolar I Disorder
- Have a current manic, depressed or mixed episode
- Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
Key exclusion criteria (6 listed)
- Pregnancy
- Substance or alcohol dependence at enrollment
- Unstable thyroid function
- Unstable Diabetes
- Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
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: Seroquel | Drug | – |
Primary outcome
Time from randomization to recurrence of a mood event
2 secondary outcomes
Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2008.
- Derived from this study: PubMed 22054050Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.
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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.
AstraZeneca CNS Medical Science Director, MD study director
AstraZeneca
95 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine fumarate in people with Bipolar Disorder, run by AstraZeneca at 95 sites in 15 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 6 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: finished, as of the sponsor's last update on 22 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Romania, India, Ukraine, Argentina and 10 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from randomization to recurrence of a mood event. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314184, which also lists 1 linked publication.
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 22 Dec 2008.