Trial Outcomes & Findings for Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (NCT NCT00882518)
NCT ID: NCT00882518
Last Updated: 2012-05-15
Results Overview
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.
COMPLETED
PHASE3
388 participants
Baseline and 6 weeks
2012-05-15
Participant Flow
388 patients from 11 sites were randomised into Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) group or chlorpromazine group.
Participant milestones
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
192
|
|
Overall Study
COMPLETED
|
158
|
148
|
|
Overall Study
NOT COMPLETED
|
38
|
44
|
Reasons for withdrawal
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
18
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
|
Overall Study
Lack of Efficacy
|
12
|
9
|
|
Overall Study
Severe non-compliance to protocol
|
3
|
1
|
|
Overall Study
Incorrect enrolment
|
4
|
2
|
|
Overall Study
Central lab closure for National day
|
1
|
0
|
|
Overall Study
Allocating random number by mistake
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Baseline characteristics by cohort
| Measure |
Seroquel_XR
n=194 Participants
Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
age
|
32.9 years
STANDARD_DEVIATION 10.70 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=159 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=150 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
|
-33.4 scores on a scale
Standard Error 1.45 • Interval 1.45 to
|
-35.9 scores on a scale
Standard Error 1.35 • Interval 1.35 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
|
-9.9 scores on a scale
Standard Error 0.53 • Interval 0.53 to
|
-11.1 scores on a scale
Standard Error 0.51 • Interval 0.51 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
|
-5.9 scores on a scale
Standard Error 0.5 • Interval 0.5 to
|
-6.7 scores on a scale
Standard Error 0.48 • Interval 0.48 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
|
-12.9 scores on a scale
Standard Error 0.74 • Interval 0.74 to
|
-13.9 scores on a scale
Standard Error 0.71 • Interval 0.71 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
|
-4.8 scores on a scale
Standard Error 0.33 • Interval 0.33 to
|
-5.4 scores on a scale
Standard Error 0.32 • Interval 0.32 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
|
-1.8 scores on a scale
Standard Error 0.18 • Interval 0.18 to
|
-1.7 scores on a scale
Standard Error 0.18 • Interval 0.18 to
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
|
57.7 Percentage of participants
|
66.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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".)
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
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
|
87.6 percentage of participants
|
88.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full analysis set was used for secondary outcome
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.
Outcome measures
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=194 Participants
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=190 Participants
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
|
-1.8 scores on a scale
Standard Error 0.12 • Interval 0.12 to
|
-2.1 scores on a scale
Standard Error 0.11 • Interval 0.11 to
|
Adverse Events
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Chlorpromazine
Serious adverse events
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=196 participants at risk
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=192 participants at risk
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/196
|
0.52%
1/192
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/196
|
0.52%
1/192
|
Other adverse events
| Measure |
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
n=196 participants at risk
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
|
Chlorpromazine
n=192 participants at risk
Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
49/196
|
16.1%
31/192
|
|
Nervous system disorders
Extrapyramidal Disorder
|
8.7%
17/196
|
30.2%
58/192
|
|
Nervous system disorders
Dizziness
|
14.3%
28/196
|
14.1%
27/192
|
|
Psychiatric disorders
Insomnia
|
12.8%
25/196
|
14.6%
28/192
|
|
Psychiatric disorders
Agitation
|
12.2%
24/196
|
10.9%
21/192
|
|
Cardiac disorders
Palpitations
|
6.1%
12/196
|
8.3%
16/192
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
6.1%
12/196
|
7.3%
14/192
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
11/196
|
7.8%
15/192
|
|
Cardiac disorders
Tachycardia
|
4.6%
9/196
|
8.9%
17/192
|
|
Cardiac disorders
Heart rate increased
|
4.1%
8/196
|
7.8%
15/192
|
|
Cardiac disorders
Orthostatic Hypotension
|
2.0%
4/196
|
9.4%
18/192
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.6%
11/196
|
4.7%
9/192
|
|
Psychiatric disorders
Somnolence
|
7.7%
15/196
|
2.1%
4/192
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
2.6%
5/196
|
6.8%
13/192
|
|
Nervous system disorders
Akathisia
|
1.5%
3/196
|
7.3%
14/192
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER