EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

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

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

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

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 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.

Age, Customized

Gender, Male/Female

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.

Modified Bond-Lader Visual Analog Scale score after 50-mg dose (Day 2)

Modified Bond-Lader Visual Analog Scale score after 100-mg dose (Day 3)

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.

Modified Bond-Lader Visual Analog Scale score after 200-mg dose (Day 4)

Modified Bond-Lader Visual Analog Scale score after 300-mg dose (Day 5)

Modified Bond-Lader Visual Analog Scale score after 300-mg dose (Day 6)

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

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 to Maximum Intensity Modified Bond-Lader Visual Analog Scale score

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

The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.

Area under the  Modified Bond-Lader Visual Analog Scale-time curve

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.

Change in Simpson-Angus Scale (SAS) total 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.

Change in Barnes Akathisia Rating Scale (BARS) global 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.

Change in Abnormal Involuntary Movement Scale (AIMS) total score

Number of patients with adverse events potentially associated with EPS  collected by MedDRA Preferred Terms as  akathisia, extrapyramidal disorder, restlessness

Number of patients with potential extrapyramidal symptoms (EPS)

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

Number of patients with potential somnolence

Overall Study

Patients must have DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed, and outpatient status at enrollment . Patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

Arms	Assigned Interventions
Active Comparator: Quetiapine Immediate Release (IR) Quetiapine 25, 100, 200 and 300 mg	Drug: Quetiapine Immediate Release Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day Other Name: Seroquel IR
Active Comparator: Quetiapine Extended Release (XR) Quetiapine 50, 200, 300	Drug: Quetiapine Extended Release Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day Other Name: Seroquel XR

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=258&filename=CSR-D1443C00040.pdf

CSR-D1443C00040.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator