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Aim of the study is to assess if the new compound Seroquel XRâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine Extended Release | Experimental |
| |
| Risperidone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Extended Release | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 week from baseline to last visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gino Montagnani, MD | AstraZeneca | Study Chair |
| Mario diFiorino | Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fermo | AP | Italy | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25356632 | Derived | 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. | |
| 24681810 |
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Adult male and female patients. with a diagnosis of schizophrenia or schizoaffective disorder (according to DSM-IVTR criteria). with depressive symptoms HAM-D baseline score ≥ 20. and HAM-D item 1 score ≥2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seroquel XR | Seroquel XR dose 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 |
| FG001 | Risperidone | Risperidone dose was 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seroquel XR | Seroquel XR dose 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Number of participants is lower than number in Participants Flow module. 6 participants, 2 in Seroquel XR and 4 in Risperidone, were not valid for safety population because they did not assume any study drug administration. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | 12 week from baseline to last visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seroquel XR | Seroquel XR dose 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disorientation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinemia | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
Multicentre, randomized, open-label, flexible dose, parallel group, non inferiority
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Risperidone | Drug | 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. |
|
|
| 12 weeks from baseline to last visit |
| 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. | 12 weeks from baseline to last visit |
| - 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 | 12 weeks from baseline to last visit |
| 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 | 12week: descriptive statistic of CGI by visit and treatment |
| 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 | 12 week from baseline to last visit |
| 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. | 12 weeks from baseline to last visit |
| 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 | 12 week from baseline to last visi |
| 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 | 12 week from screening visit to 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. | 12 week |
| 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 | Change of drug use from baseline to last visi |
| Bergamo |
| BG |
| Italy |
| Research Site | Brindisi | BR | Italy |
| Research Site | Carbonia | CA | Italy |
| Research Site | Termoli | CB | Italy |
| Research Site | Aversa | CE | Italy |
| Research Site | Catania | CT | Italy |
| Research Site | Nicosia | EN | Italy |
| Research Site | Lido di Camaiore | LU | Italy |
| Research Site | Messina | ME | Italy |
| Research Site | Milazzo | ME | Italy |
| Research Site | Monza | MI | Italy |
| Research Site | Roma | Roma | Italy |
| Research Site | Nocera Inferiore | SA | Italy |
| Research Site | Vallo della Lucania | SA | Italy |
| Research Site | La Spezia | SP | Italy |
| Research Site | Collegno | TO | Italy |
| Research Site | Frattaminore | Italy |
| Research Site | Lecco | Italy |
| Research Site | Palermo | Italy |
| Research Site | Partinico | Italy |
| 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. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Known risperidone intolerance |
|
| Past use of Seroquel -stopped due to AE |
|
| Low study drug dose |
|
| Glycosylated Hemoglobin >8 |
|
| BG001 | Risperidone | Risperidone dose was 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Risperidone | Risperidone dose was 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on scale | 12 weeks from baseline to last visit |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | 12 weeks from baseline to last visit |
|
|
|
| Secondary | - 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 | Posted | Least Squares Mean | Standard Deviation | Score on scale | 12 weeks from baseline to last visit |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 12week: descriptive statistic of CGI by visit and treatment |
|
|
|
| Secondary | 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 | Posted | Least Squares Mean | Standard Deviation | score on scale | 12 week from baseline to last visit |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | 12 weeks from baseline to last visit |
|
|
|
| Secondary | 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 | Posted | Number | Participants | 12 week from baseline to last visi |
|
|
|
| Secondary | 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 | Posted | Least Squares Mean | Standard Deviation | KG | 12 week from screening visit to last visit |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Kg/m^2 | 12 week |
|
|
|
| Secondary | 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 | Posted | Number | Participants | Change of drug use from baseline to last visi |
|
|
|
| 4 |
| 109 |
| 28 |
| EG001 | Risperidone | Risperidone dose was 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. | 4 | 107 | 21 |
| Psycotic Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Extrapiramidal Syndrome | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Faint/Syndrome | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Psycosis | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Social Stay Hospitalisation | Social circumstances | MedDRA 10.0 | Systematic Assessment |
|
| Cardiocircolatory Arresti | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Months | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Weight Increse | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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