The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
139
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
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.
Time frame: At 1 hour post-dose, Day 2 (50 mg)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 1 hour post-dose, Day 6 (300 mg)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From start of the study treatment to last dose plus 30 days