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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.

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Official Title

The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder.  This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Effectiveness of Quetiapine XR on the control of symptoms of manic phase of Bipolar Disorder.

300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening
Day 2: Two 300 mg tablet in the evening
Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Research Site

A Phase IV STudy of the Effectiveness of Quetiapine Extended Release 600mg Once a day to control the symptoms of manic phase of bipolar disorder.

Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

Participants were asked for their age in years at V0

Age Continuous

Participants were classified as male or female during V0.

Gender, Male/Female

Young Mania Rating Scale (YMRS) total score at visit 1(day 0). 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0 = normal; 4 or 8 = most abnormal. Total possible score is 0 - 60.

Young Mania Rating Scale (YMRS) total score

Study Specific Characteristic

Clinical Global Impression-Severity (CGI-S) total score at visit 1( day 0). 1 item instrument with scale range 0 to 7. 0 = patients who were not assessed, 1 = Normal 7 = the most extremely ill patients.

Clinical Global Impression-Severity (CGI-S)  total score

European Quality of Life 5 Dimensions (EQ5D) Total possible score is 0-1 (0 = The worst quality of life; 1 = The best quality of life).

European Quality of Life 5 Dimensions (EQ5D) Questionnaire Index

European Quality of Life 5 Dimensions (Eq5D) Visual Analog Scale (VAS) at visit 1(day 0). European Quality of Life 5 Dimensions (EQ5D) questionnaire part 2 has 1 item with continuous scale range 0 to 100, where 0= the worst quality of life and 100 = the best quality of life.

European Quality of Life 5 Dimensions (EQ5D) Questionnaire Visual Analogue Scale (VAS)

Simpson-Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS)total score  at visit 1 (day 0). Simpson-Angus Scale (SAS) for evaluating drug-related extrapyramidal syndromes Questionnaire has 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18. Barnes Akathisia Rating Scale (BARS) Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.

Safety scales

Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.

Change in the Young Mania Rating Scale (YMRS) total score from baseline to end of treatment (day 21)

Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.

Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88).

Change in the Young Mania Rating Scale (YMRS) total score from baseline to visit 2.

Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.

Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88).

Change in the Young Mania Rating Scale (YMRS) total score from baseline to visit 3

Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.

YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

Number of participants with Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)

Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.

YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

Number of participants with Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).

Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.

Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.

Change in the Clinical Global Impression (CGI) Total Score from Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).

Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.

Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).

Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).

Change in the Quality of Life Questionnaire EQ5D Index from Baseline to End of the Study.

Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.

Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) from Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). 

SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18.

Change in the Simpson-Angus Scale (SAS) Total Score from Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.

Change in the Barnes Akathisia Rating Scale (BARS) Total Score from Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change in Weight from Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change in Waist Circumference from Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Number of participants with >7% increase in weight from baseline to end of study.

Effectiveness of Quetiapine XR on the control of symptoms of manic phase of Bipolar Disorder. - EMMY

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

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Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=259&filename=CSR-D1443L00017.pdf

CSR-D1443L00017.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator