NCT00926393

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 31, 2011

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

June 19, 2009

Results QC Date

May 4, 2010

Last Update Submit

May 10, 2011

Conditions

Bipolar Depression

Keywords

inpatientbipolar depressionquetiapineSeroquel IRSeroquel XRsafetytolerability

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    At 1 hour post-dose, Day 3 (100 mg)

  • Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)

    At 1 hour post-dose, Day 4 (200 mg)

  • Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)

    At 1 hour post-dose, Day 5 (300 mg)

  • Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)

    At 1 hour post-dose, Day 6 (300 mg)

  • Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

    During Day 2 (50 mg)

  • +7 more secondary outcomes

Study Arms (2)

Quetiapine Immediate Release (IR)

ACTIVE COMPARATOR

Quetiapine 25, 100, 200 and 300 mg

Drug: Quetiapine Immediate Release

Quetiapine Extended Release (XR)

ACTIVE COMPARATOR

Quetiapine 50, 200, 300

Drug: Quetiapine Extended Release

Interventions

Quetiapine Immediate ReleaseDRUG

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Also known as: Seroquel IR
Quetiapine Immediate Release (IR)
Quetiapine Extended ReleaseDRUG

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Also known as: Seroquel XR
Quetiapine Extended Release (XR)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23059166DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Catherine Datto, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 23, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 11, 2011

Results First Posted

March 31, 2011

Record last verified: 2011-05