Back to resultsQuetiapine Extended Release Depression Symptoms (ExAttitude)
Primary Purpose
Schizophrenia, Depression
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Quetiapine Extended Release
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Depression, Quetiapine
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
- Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2
Exclusion Criteria:
- Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
- Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
- Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
- Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
- An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quetiapine Extended Release
Risperidone
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.
CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment.
The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.
Secondary Outcome Measures
Change From Baseline to Week 12 of HAM-D Score
21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.
Change From Baseline to Week 12 of PANSS Score
30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.
- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
CGI- Global Improvement Mean Score at Week 12
The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response
Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.
The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40
Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments.
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration
Change From Screening Visit to Week 12 of Prolactin Live
Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit
Body Mass Index (BMI) at Week 12
Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00640562
Brief Title
Quetiapine Extended Release Depression Symptoms
Acronym
ExAttitude
Official Title
Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-dose, Parallel Group, Non Inferiority, 12-week Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to Risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Depression
Keywords
Schizophrenia, Depression, Quetiapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine Extended Release
Arm Type
Experimental
Arm Title
Risperidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine Extended Release
Other Intervention Name(s)
Seroquel XR™
Intervention Description
Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
Description
The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.
CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment.
The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.
Time Frame
12 week from baseline to last visit
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 of HAM-D Score
Description
21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.
Time Frame
12 weeks from baseline to last visit
Title
Change From Baseline to Week 12 of PANSS Score
Description
30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.
Time Frame
12 weeks from baseline to last visit
Title
- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
Description
The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
Time Frame
12 weeks from baseline to last visit
Title
CGI- Global Improvement Mean Score at Week 12
Description
The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
Time Frame
12week: descriptive statistic of CGI by visit and treatment
Title
Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
Description
These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response
Time Frame
12 week from baseline to last visit
Title
Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
Description
Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.
The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40
Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments.
Time Frame
12 weeks from baseline to last visit
Title
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Description
Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration
Time Frame
12 week from baseline to last visi
Title
Change From Screening Visit to Week 12 of Prolactin Live
Description
Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit
Time Frame
12 week from screening visit to last visit
Title
Body Mass Index (BMI) at Week 12
Description
Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.
Time Frame
12 week
Title
Concomitant Use of Antidepressive Drugs From Baseline to Week 12
Description
Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration
Time Frame
Change of drug use from baseline to last visi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2
Exclusion Criteria:
Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gino Montagnani, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mario diFiorino
Organizational Affiliation
Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fermo
State/Province
AP
Country
Italy
Facility Name
Research Site
City
Bergamo
State/Province
BG
Country
Italy
Facility Name
Research Site
City
Brindisi
State/Province
BR
Country
Italy
Facility Name
Research Site
City
Carbonia
State/Province
CA
Country
Italy
Facility Name
Research Site
City
Termoli
State/Province
CB
Country
Italy
Facility Name
Research Site
City
Aversa
State/Province
CE
Country
Italy
Facility Name
Research Site
City
Catania
State/Province
CT
Country
Italy
Facility Name
Research Site
City
Nicosia
State/Province
EN
Country
Italy
Facility Name
Research Site
City
Lido Di Camaiore
State/Province
LU
Country
Italy
Facility Name
Research Site
City
Messina
State/Province
ME
Country
Italy
Facility Name
Research Site
City
Milazzo
State/Province
ME
Country
Italy
Facility Name
Research Site
City
Monza
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Nocera Inferiore
State/Province
SA
Country
Italy
Facility Name
Research Site
City
Vallo Della Lucania
State/Province
SA
Country
Italy
Facility Name
Research Site
City
La Spezia
State/Province
SP
Country
Italy
Facility Name
Research Site
City
Collegno
State/Province
TO
Country
Italy
Facility Name
Research Site
City
Frattaminore
Country
Italy
Facility Name
Research Site
City
Lecco
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Partinico
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25356632
Citation
Kasper S, Montagnani G, Trespi G, Di Fiorino M. Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone. Int Clin Psychopharmacol. 2015 Jan;30(1):14-22. doi: 10.1097/YIC.0000000000000053.
Results Reference
derived
PubMed Identifier
24681810
Citation
Di Fiorino M, Montagnani G, Trespi G, Kasper S. Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study. Int Clin Psychopharmacol. 2014 May;29(3):166-76. doi: 10.1097/YIC.0000000000000017.
Results Reference
derived
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Quetiapine Extended Release Depression Symptoms
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