Bipolar I DisorderPhase 3NCT00107731
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Phase 3 study testing quetiapine fumarate, lithium and divalproex in people with Bipolar I Disorder, run by AstraZeneca at 166 sites in 18 countries.
Trial summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- quetiapine fumarate, lithium and divalproex
- How many people
- 710 participants
- Where
- 166 sitesin 18 countries
- Study dates
- Apr 2004to Oct 2006
- 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
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
Who cannot join
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
Trial locations and contacts
166 sites in 18 countries.
166 sites in 18 countries
United States36 sites
Research Site
Beverly Hills, California
Research Site
Birmingham, Alabama
Research Site
Brooklyn, New York
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Chula Vista, California
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Conroe, Texas
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Gainesville, Florida
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Glen Burnie, Maryland
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Granite City, Illinois
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Havertown, Pennsylvania
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Houston, Texas
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Jacksonville, Florida
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Kalamazoo, Michigan
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Libertyville, Illinois
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Media, Pennsylvania
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Metairie, Louisiana
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Miami, Florida
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Milwaukee, Wisconsin
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Morganton, North Carolina
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Oklahoma City, Oklahoma
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Olean, New York
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Philadelphia, Pennsylvania
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Portland, Oregon
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Raleigh, North Carolina
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Redlands, California
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Richmond, Virginia
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Rochester, New York
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Saint Charles, Missouri
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San Francisco, California
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Santa Ana, California
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Sarasota, Florida
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Schaumburg, Illinois
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Seattle, Washington
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St Louis, Missouri
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Tampa, Florida
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Wichita, Kansas
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Winter Park, Florida
Poland17 sites
Research Site
Bialystok
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Bydgoszcz
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Choroszcz
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Gdansk
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Gorlice
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Janów Lubelski
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Krakow
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Lipno
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Lodz
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Lublin
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Nowy Targ
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Poznan
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Starogard Gdański
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Szczecin
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Torun
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Warsaw
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Zubki
Italy15 sites
Research Site
Bari
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Bergamo
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Brescia
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Cagliari
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Civitanova Marche
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Florence
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Genova
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La Spezia
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Milan
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Naples
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Padova
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Pisa
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Roma
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Siena
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Trieste
Spain13 sites
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Barcelona, Barcelona
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Bilbao
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Granada, Granada
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Guadalajara
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Langreo, Principality of Asturias
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Madrid, Madrid
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Oviedo, Oviedo
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Oviedo, Principality of Asturias
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Puerto Real, Cádiz
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Santiago de Compostela
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Seville, Sevilla
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Terrassa, Barcelona
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Vigo
Australia9 sites
Research Site
Box Hill, Victoria
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Brisbane, Queensland
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Dandenong, Victoria
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Epping, Victoria
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Everton Park, Queensland
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Glenside, South Australia
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Greenwich, New South Wales
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Richmond, Victoria
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Southport, Queensland
France9 sites
Research Site
Besançon
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Bourg-en-Bresse
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La Rochelle
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Marseille
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Montpellier
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Nîmes
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Paris
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Strasbourg
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Toulouse
Germany8 sites
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Augsburg
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Berlin
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Cologne
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Heidelberg
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Homburg
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München
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Regensburg
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Saarbrücken
Belgium7 sites
Research Site
Assebroek
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Brussels
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Ghent
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Kortenberg
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Manage
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St-Denijs-Westrem
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Waregem
Norway7 sites
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Bergen
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Bodø
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Bryne
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Namsos
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Oslo
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Ottestad
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Skien
United Kingdom7 sites
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Birmingham
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London
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Oxford
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Runcorn
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Ryhope
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Surbiton
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Welwyn Garden City
Hungary6 sites
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Budapest
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Füzesabony
Research Site
Győr
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Kecskemét
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Kistarcsa
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Pécs
Sweden6 sites
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Falköping
Research Site
Linköping
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Ludvika
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Sollentuna
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Stockholm
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Sundsvall
Czechia5 sites
Research Site
Jeseník
Research Site
Litomolice
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Olomouc
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Prague
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Pterova
Finland5 sites
Research Site
Espoo
Research Site
Harjavalta
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Helsinki
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Kellokoski
Research Site
Seinäjoki
South Africa5 sites
Research Site
Bloemfontein
Research Site
Durban
Research Site
Johannesburg
Research Site
Krugersdorp
Research Site
Pretoria
Bulgaria4 sites
Research Site
Kardzhali
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Turkey (Türkiye)4 sites
Research Site
Adana
Research Site
Ankara
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Istanbul
Research Site
Izmir
Russia3 sites
Research Site
Moscow
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Saint Petersburg
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Saratov
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
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 I Disorder
- Being tested
- quetiapine fumarate, lithium, divalproex
- Keywords
- Bipolar I Disorder, Manic Depressive Disorder, Manic Depression
- 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
lithiumDrug
divalproexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Secondary outcomes (1)
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2005 (estimated)
- Study startApr 2004
- Study completionOct 2006
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 I 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 710 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107731
- Sponsor's protocol ID
- D1447C00126
- Status last verified
- Mar 2009
- First submitted
- 7 Apr 2005
- Last updated
- 25 Mar 2009
- Results posted
- No
Publications
Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
PubMed 23761037
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
- ClinicalTrials.gov ID
- NCT00107731
- Acronym / sponsor ID
- D1447C00126
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Manic Depressive Disorder, Manic Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Apr 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 purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
Key exclusion criteria (3 listed)
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
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 fumarate | Drug | – |
| lithium | Drug | – |
| divalproex | Drug | – |
Primary outcome
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
1 secondary outcome
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic 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 25 Mar 2009.
- Derived from this study: PubMed 23761037Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
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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 Seroquel Medical Science Director, MD study director
AstraZeneca
166 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine fumarate, lithium and divalproex in people with Bipolar I Disorder, run by AstraZeneca at 166 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 3 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: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 166 sites in United States, Poland, Italy, Spain, Australia 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. 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?
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time 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 NCT00107731, 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 25 Mar 2009.