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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

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)

Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Efficacy and safety of quetiapine fumarate in the treatment of schizophrenic patients

Research Site

A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients with Acute Episode

6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.

Age Continuous

Gender, Male/Female

Per-protocol population was used as the analysis set for primary outcome, because this is  a non-inferior design study.

Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42

6 weeks minus baseline
PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

Full analysis set was used for secondary outcome

Change from baseline in PANSS positive subscale score at the end of treatment at Day 42

6 weeks minus baseline
PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme
The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

Change from baseline in PANSS negative subscale score at the end of treatment at Day 42

The PANSS psychopathological subscale score is the sum of 16 item scores(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), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

Change from baseline in PANSS General Psychopathological Subscale Score at the end of treatment at Day 42

6 weeks minus baseline
PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).
1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme

Change from baseline in PANSS aggression, hostility clusters score at the end of treatment at Day 42

Change from baseline in PANSS depression clusters score at the end of treatment at Day 42

6 weeks minus baseline
PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.
1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme.

Number of patients achieving a reduction of at least 30% from baseline PANSS total score at the end of treatment at Day 42

6 weeks minus baseline.  The number of patients with CGI Global Improvement (CGI-I) rating at least “minimally improved” at the end of treatment at Day 42  was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient’s change from baseline CGI on a seven-point scale (1=”Very much improved”, 7=”Very much worse".)

Percentage of patients with Clinical Global Impression (CGI) Global Improvement rating less than or equal to 3 at the end of treatment at Day 42

6 weeks minus baseline
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Change in the CGI Severity of Illness score from baseline at the end of treatment at Day 42

Overall Study

388 patients from 11 sites were randomised into Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
group or chlorpromazine group.

Arms	Assigned Interventions
Experimental: 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)	Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) 200 mg or 300 mg, oral, single dose Other Name: Seroquel_XR (Quetiapine Fumarate XR)
Active Comparator: 2-Chlorpromazine Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)	Drug: Chlorpromazine 50 mg, oral, double dose

Efficacy and safety of quetiapine fumarate in the treatment of schizophrenic patients - ESPRIT

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=274&filename=CSR-D1444C00008.pdf

CSR-D1444C00008.pdf

Trial Results Summaries

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