Bipolar DepressionPhase 3NCT00811473
Pediatric Bipolar Depression
A Phase 3 study testing Quetiapine XR in people with Bipolar Depression, run by AstraZeneca at 48 sites in 7 countries.
Trial summary
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Quetiapine XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 48 sitesin 7 countries
- Study dates
- Jan 2009to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
- Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
- Patients must be able to swallow the study medication tablets.
Who cannot join
- The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
- Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
- The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
- Patients who in your doctors judgement pose a current suicidal or homicidal risk.
Trial locations and contacts
48 sites in 7 countries.
48 sites in 7 countries
United States31 sites
Research Site
Atlanta, Georgia
Research Site
Bothell, Washington
Research Site
Bradenton, Florida
Research Site
Charleston, South Carolina
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Clinton Township, Michigan
Research Site
Dothan, Alabama
Research Site
Eagle, Idaho
Research Site
Escondido, California
Research Site
Flowood, Mississippi
Research Site
Gainsville, Florida
Research Site
Hoffman Estates, Illinois
Research Site
Lincoln, Nebraska
Research Site
Little Rock, Arkansas
Research Site
Mason, Ohio
Research Site
Memphis, Tennessee
Research Site
Milwaukee, Wisconsin
Research Site
Minneapolis, Minnesota
Research Site
North Miami, Florida
Research Site
Oklahoma City, Oklahoma
Research Site
Overland Park, Kansas
Research Site
Rochester, New York
Research Site
Scottsdale, Arizona
Research Site
Smyrna, Georgia
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
Terre Haute, Indiana
Research Site
Virginia Beach, Virginia
Research Site
Wharton, Texas
Research Site
Wichita, Kansas
Colombia4 sites
Research Site
Bello
Research Site
Bogotá
Research Site
Bogota D.c, Cundinamarca
Research Site
Medellín
India4 sites
Research Site
Ahmedabad, Gujarat
Research Site
Vadodara, Gujarat
Research Site
Varanasi, Uttar Prad
Research Site
Vijaywada, Andh Prad
Taiwan3 sites
Research Site
Changhua
Research Site
Taipei
Research Site
Taoyuan, Taiwan
South Africa2 sites
Research Site
Cape Town, W Cape
Research Site
Pretoria, Gauteng
About this study
Official title: An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
- Conditions
- Bipolar Depression
- Being tested
- Quetiapine XR, Placebo
- Keywords
- Bipolar Depression, Depression, Children, Adolescents, Seroquel, Bipolar Depression in Children and Adolescents
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
Also called Seroquel XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
PlaceboDrug
Oral treatment once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine XR | Experimental | Not described Receives: Drug: Quetiapine XR |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
Measured: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Secondary outcomes (5)
Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
Measured: Days 8 to 57
The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score
The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
Measured: Days 8 to 57
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.
Measured: Change from Baseline to Day 57
CGI-BP-C Score at Final Assessment (Day 57)
The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.
Measured: Change from Baseline to day 57
The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment.
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies 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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Castiglione, Study director, AstraZenecaRobert L. Findling, Principal investigator, University Hospitals Case Medical CenterCase Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811473
- Sponsor's protocol ID
- D144AC00001
- Status last verified
- Jul 2014
- First submitted
- 18 Dec 2008
- Last updated
- 15 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Findling RL, Pathak S, Earley WR, Liu S, DelBello MP. Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2014 Aug;24(6):325-35. doi: 10.1089/cap.2013.0105. Epub 2014 Jun 23.
PubMed 24956042
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression
- ClinicalTrials.gov ID
- NCT00811473
- Acronym / sponsor ID
- D144AC00001
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, Depression, Children, Adolescents, Seroquel, Bipolar Depression in Children and Adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 1 Dec 2011
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 if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
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 |
|---|---|---|
| Quetiapine XR | Experimental | Drug: Quetiapine XR |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
- Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
- Patients must be able to swallow the study medication tablets.
Key exclusion criteria (4 listed)
- The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
- Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
- The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
- Patients who in your doctors judgement pose a current suicidal or homicidal risk.
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 XRAlso: Seroquel XROral treatment with 150 up to 300 mg/day once daily in the evening | Drug | Quetiapine XR |
| PlaceboOral treatment once daily in the evening | Drug | Placebo |
Primary outcome
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
Time frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
5 secondary outcomes
Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
Time frame: Days 8 to 57
The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score
Time frame: Days 8 to 57
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
Time frame: Change from Baseline to Day 57
CGI-BP-C Score at Final Assessment (Day 57)
Time frame: Change from Baseline to day 57
The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
Time frame: Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24956042Findling RL, Pathak S, Earley WR, Liu S, DelBello MP. Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2014 Aug;24(6):325-35. doi: 10.1089/cap.2013.0105. Epub 2014 Jun 23.
- CSR-D144AC00001.pdfLink provided by the sponsor.
- D144AC00001\_Redacted\_Study\_ProtocolLink provided by the sponsor.
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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.
Michael Castiglione study director
AstraZeneca
Robert L. Findling principal investigator
University Hospitals Case Medical CenterCase Western Reserve University School of Medicine
48 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine XR in people with Bipolar Depression, run by AstraZeneca at 48 sites in 7 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 4 inclusion and 4 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 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Colombia, India, Taiwan, Mexico and 2 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) (time frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57). 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 NCT00811473, 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 15 Jul 2014.