Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Quetiapine Fumarate, Quetiapine fumarate (Seroquel), Quetiapine fumarate, Quetiapine SR, quetiapine fumarate, Quetiapine XR, Quetiapine fumarate (Seroquel) SR, quetiapine fumarate XR
Quetiapine · 52 trials · 32 indications
The Clinical Global Impression Improvement Score of \< 2 (much or very much improved) will be used to quantify the adolescent's change in overall severity of illness.
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
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.
The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.
Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional
30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.
90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms
Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms
Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment
Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit 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.
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)
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
Number of participants that had AE which occurred from first dose date to last dose date + 30 days.
Number of subjects who withdrew from the study due to AEs.
Clinical important shift to high prolactin from open-label (OL) baseline to week 26. High Prolactin is defined as value \>26 ug/L for female and value \>20 ug/L for male.
Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse). Improved define as those with a \<= -1 change in SAS total score. Worsened defined as those with a \>=1 change in SAS total score.
Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse. Improved defined as those with a \<= -1 change in BARS global score. Worsened defined as those with a \>= 1 change in BARS global score.
Number with 7% or more increase (without adjustment for normal growth)
Change from OL baseline to week 26 in supine pulse (bpm)
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
| Arm | Type | Description |
|---|---|---|
| Quetiapine | EXPERIMENTAL | Patients will begin 100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks). |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Quetiapine Extended Release | EXPERIMENTAL | Lithium or valproate at stable doses within seric therapeutic levels |
| Sertraline | ACTIVE_COMPARATOR | Lithium or valproate at stable doses within seric therapeutic levels |
| 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) | EXPERIMENTAL | Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day) |
| 2-Chlorpromazine | ACTIVE_COMPARATOR | Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days) |
| Quetiapin fumarate XR | EXPERIMENTAL | Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. |
| Quetiapin fumarate XR+Lithium carbonate | EXPERIMENTAL | Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56. |
| Quetiapine XR | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Add-on Quetiapine XR+SSRI/Venlafaxine | ACTIVE_COMPARATOR | Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline. |
| Add-on Lithium+SSRI/Venlafaxine | ACTIVE_COMPARATOR | Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline. |
| Monotherapy Quetiapine XR | ACTIVE_COMPARATOR | Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od) |
| 3 | PLACEBO_COMPARATOR | Equivalent number of placebo oral tablets taken daily for 8 weeks. |
| Risperidone | ACTIVE_COMPARATOR | - |
| Quetapine XR | EXPERIMENTAL | Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. |
| A | EXPERIMENTAL | Quetiapine at dosage of 50 to 150 mg |
| Name | Type | Description |
|---|---|---|
| Quetiapine | DRUG | - |
| Quetiapine Fumarate (SEROQUEL) Extended Release | DRUG | Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. |
| Placebo | DRUG | Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. |
| Extended release quetiapine (quetiapine XR) | DRUG | Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. |
| Sertraline | DRUG | Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study. |
| adequate mood stabilizer | DRUG | An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively). |
| Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) | DRUG | 200 mg or 300 mg, oral, single dose |
| Chlorpromazine | DRUG | 50 mg, oral, double dose |
| Quetiapine fumarate XR | DRUG | Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. |
| Lithium carbonate | DRUG | Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day |
| Quetiapine XR | DRUG | Oral treatment with 150 up to 300 mg/day once daily in the evening |
| SSRI/Venlafaxine | DRUG | SSRI - doses within label, Venlafaxine dose up to 225 mg/day |
| quetiapine extended-release | DRUG | Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo |
| Quetiapine Fumarate Extended- Release | DRUG | Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening. |
| 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 |
| 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. |
| Quetiapine fumarate (Seroquel) SR | DRUG | - |
| Amitriptyline | DRUG | - |
| Bupropion | DRUG | - |
| Citalopram | DRUG | - |
| Duloxetine | DRUG | - |
| Escitalopram | DRUG | - |
| Fluoxetine | DRUG | - |
| Paroxetine | DRUG | - |
| Venlafaxine | DRUG | - |
| Quetiapine SR | DRUG | - |
| Quetiapine fumarate | DRUG | - |
| Escitalopram oxylate | DRUG | - |
| lithium | DRUG | - |
| divalproex | DRUG | - |
| quetiapine fumarate (Seroquel) | DRUG | - |
| mood stabilizing activity | BEHAVIORAL | - |
| quetiapine fumarate placebo | DRUG | oral 0 mg |
| quetiapine fumarate tablets | DRUG | - |
| SSRI/Clomipramine | DRUG | - |
| quetiapine fumarate extended-release | DRUG | 200mg,oral,single dose |
Inclusion Criteria: To be included in this study, subjects must meet the following criteria: 1. Male or female patients, 12-18 years of age. 2. Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence). 3. Each patien...