Bipolar DepressionPhase 4NCT00926393

Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

A Phase 4 study testing Quetiapine Immediate Release and Quetiapine Extended Release in people with Bipolar Depression, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Bipolar Depression
What is being tested?: Quetiapine Immediate Release and Quetiapine Extended Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: No sites listed yet
Study dates: Jun 2009to Aug 2009
Phase: Phase 4
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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
Outpatient status as enrollment

Who cannot join

Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

About this study

Official title: A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Conditions: Bipolar Depression
Being tested: Quetiapine Immediate Release, Quetiapine Extended Release
Keywords: inpatient, bipolar depression, quetiapine, Seroquel IR, Seroquel XR, safety, tolerability
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 Immediate ReleaseDrug
Also called Seroquel IR
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Quetiapine Extended ReleaseDrug
Also called Seroquel XR
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Study groups in NCT00926393
Study group	Role	What they receive
Quetiapine Immediate Release (IR)	Active comparator	Quetiapine 25, 100, 200 and 300 mg Receives: Drug: Quetiapine Immediate Release
Quetiapine Extended Release (XR)	Active comparator	Quetiapine 50, 200, 300 Receives: Drug: Quetiapine Extended Release

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Measured: At 1 hour post-dose, Day 2 (50 mg)

Secondary outcomes (12)

Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Measured: At 1 hour post-dose, Day 3 (100 mg)
Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Measured: At 1 hour post-dose, Day 4 (200 mg)
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Measured: At 1 hour post-dose, Day 5 (300 mg)
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
Measured: At 1 hour post-dose, Day 6 (300 mg)
Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments
Measured: During Day 2 (50 mg)
Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas
Measured: During Day 2 (50 mg)
Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose
Measured: During Day 2 (50 mg)
Change in Simpson-Angus Scale (SAS) Total Score
SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.
Measured: Randomization to Day 7
Change in Barnes Akathisia Rating Scale (BARS) Global Score
BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.
Measured: Randomization to Day 7
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.
Measured: Randomization to Day 7
Number of Patients With Potential Extrapyramidal Symptoms (EPS)
Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness
Measured: From start of the study treatment to last dose plus 30 days
Number of Patients With Potential Somnolence
Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence
Measured: From start of the study treatment to last dose plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Aug 2009

First posted23 Jun 2009 (estimated)
Study startJun 2009
Primary completionAug 2009
Study completionAug 2009

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 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926393
Sponsor's protocol ID: D1443C00040
Status last verified: May 2011
First submitted: 19 Jun 2009
Last updated: 11 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.
PubMed 23059166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression
ClinicalTrials.gov ID: NCT00926393
Acronym / sponsor ID: D1443C00040
Conditions: Bipolar Depression
Keywords: inpatient, bipolar depression, quetiapine, Seroquel IR, Seroquel XR, safety, tolerability
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 31 Mar 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 the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Quetiapine Immediate Release (IR)	Active comparator	Drug: Quetiapine Immediate ReleaseQuetiapine 25, 100, 200 and 300 mg
Quetiapine Extended Release (XR)	Active comparator	Drug: Quetiapine Extended ReleaseQuetiapine 50, 200, 300

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
Outpatient status as enrollment

Key exclusion criteria (1 listed)

Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

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 Immediate ReleaseAlso: Seroquel IROral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day	Drug	Quetiapine Immediate Release (IR)
Quetiapine Extended ReleaseAlso: Seroquel XROral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day	Drug	Quetiapine Extended Release (XR)

Primary outcome

Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
Time frame: At 1 hour post-dose, Day 2 (50 mg)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.

12 secondary outcomes

Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
Time frame: At 1 hour post-dose, Day 3 (100 mg)
Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
Time frame: At 1 hour post-dose, Day 4 (200 mg)
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
Time frame: At 1 hour post-dose, Day 5 (300 mg)
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
Time frame: At 1 hour post-dose, Day 6 (300 mg)
Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
Time frame: During Day 2 (50 mg)
Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
Time frame: During Day 2 (50 mg)
Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
Time frame: During Day 2 (50 mg)
Change in Simpson-Angus Scale (SAS) Total Score
Time frame: Randomization to Day 7
Change in Barnes Akathisia Rating Scale (BARS) Global Score
Time frame: Randomization to Day 7
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
Time frame: Randomization to Day 7
Number of Patients With Potential Extrapyramidal Symptoms (EPS)
Time frame: From start of the study treatment to last dose plus 30 days
Number of Patients With Potential Somnolence
Time frame: From start of the study treatment to last dose plus 30 days

Results and safety

Results posted to the registry on 31 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quetiapine IR	69	67
Quetiapine XR	70	67

Primary outcome: Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)

Time frame: At 1 hour post-dose, Day 2 (50 mg). Least squares mean (95% Confidence Interval). Unit: units on scale

Measure	Quetiapine IR n = 65	Quetiapine XR n = 69
Value	45.022 (38.287 to 51.758)	32.472 (25.935 to 39.009)

Population analysed: The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quetiapine IR	0 of 69 (0%)	33 of 69 (47.8%)	Not reported
Quetiapine XR	3 of 70 (4.3%)	29 of 70 (41.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23059166Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.

Related trials for Bipolar Depression

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Recruiting
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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.

Catherine Datto, MD study director

AstraZeneca

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quetiapine Immediate Release and Quetiapine Extended Release in people with Bipolar Depression, run by AstraZeneca.

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 2 inclusion and 1 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 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 31 Mar 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?

Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) (time frame: At 1 hour post-dose, Day 2 (50 mg)). 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 NCT00926393, 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 11 May 2011.