Quetiapine Extended Release Depression Symptoms (ExAttitude)
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|ClinicalTrials.gov Identifier: NCT00640562|
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Depression||Drug: Quetiapine Extended Release Drug: Risperidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Experimental: Quetiapine Extended Release||
Drug: Quetiapine Extended Release
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
Other Name: Seroquel XR™
|Active Comparator: Risperidone||
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.
Other Name: Risperdal
- Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score. [ Time Frame: 12 week from baseline to last visit ]
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.
- Change From Baseline to Week 12 of HAM-D Score [ Time Frame: 12 weeks from baseline to last visit ]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 [ Time Frame: 12 weeks from baseline to last visit ]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 [ Time Frame: 12 weeks from baseline to last visit ]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 [ Time Frame: 12week: descriptive statistic of CGI by visit and treatment ]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 [ Time Frame: 12 week from baseline to last visit ]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 [ Time Frame: 12 weeks from baseline to last visit ]
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 [ Time Frame: 12 week from baseline to last visi ]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 [ Time Frame: 12 week from screening visit to last visit ]Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit
- Body Mass Index (BMI) at Week 12 [ Time Frame: 12 week ]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 [ Time Frame: Change of drug use from baseline to last visi ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640562
|Fermo, AP, Italy|
|Bergamo, BG, Italy|
|Brindisi, BR, Italy|
|Carbonia, CA, Italy|
|Termoli, CB, Italy|
|Aversa, CE, Italy|
|Catania, CT, Italy|
|Nicosia, EN, Italy|
|Lido Di Camaiore, LU, Italy|
|Messina, ME, Italy|
|Milazzo, ME, Italy|
|Monza, MI, Italy|
|Nocera Inferiore, SA, Italy|
|Vallo Della Lucania, SA, Italy|
|La Spezia, SP, Italy|
|Collegno, TO, Italy|
|Study Chair:||Gino Montagnani, MD||AstraZeneca|
|Principal Investigator:||Mario diFiorino||Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)|