Quetiapine XR
DrugOral, once daily, tablets of 400 mg to 800 mg
Other names: Seroquel XR
NCT Number: NCT00600756
The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Research Site, Assebroek, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral, once daily, tablets of 400 mg to 800 mg
Other names: Seroquel XR
Oral, once daily, tablets of 2 mg to 6 mg
Other names: Risperdal
Time frame: 6 months
The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)
Time frame: Baseline and Month 12
The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.
Time frame: Baseline and Month 12
The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.
Time frame: Baseline and 12 months
The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.
Time frame: Baseline and 12 months
The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.
Time frame: Baseline and 12 months
The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.
Time frame: Baseline and 12 months
The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.
Time frame: Baseline and 12 months
The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.
Time frame: 12 months
Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12
Time frame: 12 months
For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.
Time frame: 12 months
For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).
Time frame: 12 months
The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.
Time frame: 12 months
Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.
Time frame: 12 months
The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).
Time frame: 12 months
Stable State was defined as having the same status in occupational and residential status as at Baseline.
Time frame: 12 months
Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".
Time frame: 12 months
All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.
Time frame: Month 12
Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.
Time frame: 12 months
Time frame: 12 months
The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup "N06-Antidepressants".
Time frame: 12 months
Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.
Time frame: 12 months
Time frame: 12 months
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time frame: 12 months
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time frame: 12 months
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time frame: 12 months
Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.
Time frame: 12 months
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time frame: 12 months
The normal range for men is 0 to 14, and for women is 0 to 24.
Time frame: 12 months
Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.
Time frame: Month 12
Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.
Time frame: Month 12
Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.
AstraZeneca
Industry
A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting
Acronym: RECOVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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