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Trial record 47 of 450 for:    QUETIAPINE

Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (ESPRIT)

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ClinicalTrials.gov Identifier: NCT00882518
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Drug: Chlorpromazine
Enrollment 388
Recruitment Details  
Pre-assignment Details 388 patients from 11 sites were randomised into Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) group or chlorpromazine group.
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 196 192
Completed 158 148
Not Completed 38 44
Reason Not Completed
Adverse Event             9             18
Withdrawal by Subject             9             13
Lack of Efficacy             12             9
Severe non-compliance to protocol             3             1
Incorrect enrolment             4             2
Central lab closure for National day             1             0
Allocating random number by mistake             0             1
Arm/Group Title Seroquel_XR Chlorpromazine Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 194 190 384
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
age Number Analyzed 194 participants 190 participants 384 participants
32.9  (10.70) 32.0  (10.33) 32.5  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 190 participants 384 participants
Female
102
  52.6%
100
  52.6%
202
  52.6%
Male
92
  47.4%
90
  47.4%
182
  47.4%
1.Primary Outcome
Title Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 159 150
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-33.4  (1.45) -35.9  (1.35)
2.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-9.9  (0.53) -11.1  (0.51)
3.Secondary Outcome
Title Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-5.9  (0.5) -6.7  (0.48)
4.Secondary Outcome
Title Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-12.9  (0.74) -13.9  (0.71)
5.Secondary Outcome
Title Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
Hide Description

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

Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-4.8  (0.33) -5.4  (0.32)
6.Secondary Outcome
Title Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
Hide Description

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

Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.8  (0.18) -1.7  (0.18)
7.Secondary Outcome
Title Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
Hide Description

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.

Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Measure Type: Number
Unit of Measure: Percentage of participants
57.7 66.3
8.Secondary Outcome
Title 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
Hide Description 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".)
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Measure Type: Number
Unit of Measure: percentage of participants
87.6 88.9
9.Secondary Outcome
Title Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set was used for secondary outcome
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 194 190
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.8  (0.12) -2.1  (0.11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Hide Arm/Group Description 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 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.
All-Cause Mortality
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/196 (0.00%)   2/192 (1.04%) 
Nervous system disorders     
Grand Mal Convulsion  1  0/196 (0.00%)  1/192 (0.52%) 
Psychiatric disorders     
Suicide Attempt  1  0/196 (0.00%)  1/192 (0.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Chlorpromazine
Affected / at Risk (%) Affected / at Risk (%)
Total   142/196 (72.45%)   166/192 (86.46%) 
Cardiac disorders     
Palpitations  12/196 (6.12%)  16/192 (8.33%) 
Tachycardia  9/196 (4.59%)  17/192 (8.85%) 
Heart rate increased  8/196 (4.08%)  15/192 (7.81%) 
Orthostatic Hypotension  4/196 (2.04%)  18/192 (9.38%) 
Gastrointestinal disorders     
Constipation  1  49/196 (25.00%)  31/192 (16.15%) 
Diarrhea  11/196 (5.61%)  15/192 (7.81%) 
Hepatobiliary disorders     
Hepatic Function Abnormal  11/196 (5.61%)  9/192 (4.69%) 
Nervous system disorders     
Extrapyramidal Disorder  17/196 (8.67%)  58/192 (30.21%) 
Dizziness  28/196 (14.29%)  27/192 (14.06%) 
Akathisia  3/196 (1.53%)  14/192 (7.29%) 
Psychiatric disorders     
Insomnia  25/196 (12.76%)  28/192 (14.58%) 
Agitation  24/196 (12.24%)  21/192 (10.94%) 
Somnolence  15/196 (7.65%)  4/192 (2.08%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  12/196 (6.12%)  14/192 (7.29%) 
Nasopharyngitis  5/196 (2.55%)  13/192 (6.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00882518     History of Changes
Other Study ID Numbers: D1444C00008
First Submitted: April 14, 2009
First Posted: April 16, 2009
Results First Submitted: March 7, 2011
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012