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Completed

NCT Number: NCT00926393

Study Comparing the Tolerability of Seroquel IR With Seroquel XR 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.

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Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Quetiapine Immediate Release

Drug

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

Other names: Seroquel IR

Quetiapine Extended Release

Drug

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

Other names: Seroquel XR

Primary outcomes

  1. 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.

Secondary outcomes

  1. Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)

    Time frame: At 1 hour post-dose, Day 3 (100 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.

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

    Time frame: At 1 hour post-dose, Day 4 (200 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.

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

    Time frame: At 1 hour post-dose, Day 5 (300 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.

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

    Time frame: At 1 hour post-dose, Day 6 (300 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.

  5. Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

    Time frame: During Day 2 (50 mg)

    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

  6. Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

    Time frame: During Day 2 (50 mg)

    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

  7. Area Under the Modified Bond-Lader Visual Analog Scale-time Curve

    Time frame: During Day 2 (50 mg)

    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

  8. Change in Simpson-Angus Scale (SAS) Total Score

    Time frame: Randomization to Day 7

    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.

  9. Change in Barnes Akathisia Rating Scale (BARS) Global Score

    Time frame: Randomization to Day 7

    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.

  10. Change in Abnormal Involuntary Movement Scale (AIMS) Total Score

    Time frame: Randomization to Day 7

    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.

  11. 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 adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness

  12. Number of Patients With Potential Somnolence

    Time frame: From start of the study treatment to last dose plus 30 days

    Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2009
Registry last updated
May 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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