EU Clinical Trial Information System (CTIS)

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

Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.

The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.

Efficacy and safety of SEROQUEL extended release (XR) in acute schizophrenia

Research Site

A 3 weeks open label study to evaluate the efficacy in agitation and safety of Quetiapine fumarate XR in treatment of patients with acute schizophrenia

PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from ‘absent’ to ‘extremely severe’ (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.

Age Categorical

Age Continuous

Gender, Male/Female

Region of Enrollment

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.

Change from baseline in positive and negative syndrome scale excited component (PANSS-EC) score

Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation,  Uncooperativeness, Unusual thought content,  Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy. 
Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.

Change from baseline to final visit at Day 21 in PANSS Positive, general psychopathological scores.

Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation,  Uncooperativeness, Unusual thought content,  Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.

Change from baseline to final visit at Day 21 in PANSS Negative, General Psychopathological scores

Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject’s mental illness. A reduction in score indicates an improvement in the subject’s condition. The CGI-S assessment should be based upon the subject’s symptoms during the previous week. 
Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point.

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.

Change from baseline in Clinical Global Impression-Severity Scale  (CGI-S)

Baseline

Day 21

Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject’s mental. A reduction in score indicates an improvement in the subject’s condition. This assessment is based on the improvement since initiation of the study treatment. 
Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score.

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.

Change from baseline in absolute Clinical Global Impression-Improvement (CGI-I) scale

Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.
Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.
Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). 
This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation).

ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.

Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score compared from baseline to Day 21.

Overall Study

40 patients enrolled, 35 patients randomised and 28 patients completed the study

Efficacy and safety of SEROQUEL extended release (XR) in acute schizophrenia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=271&filename=CSR-D1443L00074.pdf

CSR-D1443L00074.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator