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SEROQUEL

Phase 4

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Trials Updated: Mar 9, 2017

SEROQUEL development status

Highest phase Phase 4 (NCT00428350)
Phase scored for AZNPhase 3
Registered trials 76 across 27 sponsors since Jun 2003

SEROQUEL target and mechanism

ModalitySmall molecule

Also known as SEROQUEL XR (quetiapine), SEROQUEL (quetiapine fumarate) Tablets, Seroquel SR, Seroquel (quetiapine), Quetiapine, Quetiapine fumarate, Quetiapine fumarate (Seroquel), Quetiapine IR (Immediate Release)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials59
Total Enrollment20,023

FDA Designations

No designations recorded

SEROQUEL clinical trials

SEROQUEL · 59 trials · 33 indications

Phase 3 53Phase 2 4Phase 1 2
NCT00221468A Study of Quetiapine for the Treatment of Mood Disorders in AdolescentsMood Disorders
COMPLETED20 Analytics
NCT00232414A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar DisorderBipolar I Disorder
COMPLETED30 Analytics
NCT01256177Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar DepressionBipolar Depression
COMPLETED361 Analytics
NCT00857584Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on TherapyBipolar Disorder
COMPLETED27 Analytics
NCT00882518Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic PatientsSchizophrenia
COMPLETED388 Analytics
NCT00883493Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar DepressionAcute Bipolar Depression
COMPLETED421 Analytics
NCT00811473Pediatric Bipolar DepressionBipolar Depression
COMPLETED193 Analytics
NCT00789854Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD PatientsMajor Depressive Disorder
COMPLETED688 Analytics
NCT00773162Flushing in Social Anxiety Disorder on SeroquelSocial Anxiety Disorder
COMPLETED21 Analytics
NCT00880919Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)Borderline Personality Disorder
COMPLETED95 Analytics
PHASE3COMPLETED
A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Mood DisordersUnlock trial analytics
PHASE3COMPLETED
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Bipolar DepressionUnlock trial analytics
PHASE3COMPLETED
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Bipolar DisorderUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Acute Bipolar DepressionUnlock trial analytics
PHASE3COMPLETED
Pediatric Bipolar Depression
Bipolar DepressionUnlock trial analytics
PHASE3COMPLETED
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Flushing in Social Anxiety Disorder on Seroquel
Social Anxiety DisorderUnlock trial analytics
PHASE3COMPLETED
Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
Borderline Personality DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Global Impression Improvement (CGI)
12 weeks

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.

Children's Depression Rating Scale (CDRS): Measure of efficacy will be a change in CDRS total scores from baseline endpoint.
Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline to Week 8

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

The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
baseline, week 2

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)

Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
Baseline and 6 weeks

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.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Baseline, 8 weeks

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.

Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57

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 Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
6 weeks treatment

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 Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
6 weeks of treatment

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.

Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
20 weeks
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
baseline, weekly until week 8

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.

Montgomery-Åsberg Depression Rating Scale (MADRS)
baseline to 8 weeks

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.

Borderline Evaluation of Severity Over Time (BEST)
Baseline to 8 weeks

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).

Overt Aggression Scale - Modified (OAS-M)
Change from Baseline Overt Aggression Scale - Modified to 8 weeks

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.

Global Assessment of Functioning Scale (GAF)
Change in Global Assessment of Functioning from Baseline to 8 weeks

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

Barratt Impulsiveness Scale (BIS)
Change in Impulsiveness from Baseline to 8 weeks

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.

Symptom Checklist -90-Revised (SCL-90-R)
Change in psychological problems and symptoms from Baseline to 8 weeks

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

Young Mania Rating Scale (YMS)
Change in manic symptoms from Baseline to 8 weeks

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

Sheehan Disability Scale (SDS)
Change in functional impairment from Baseline to 8 weeks

Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment

Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study
Baseline to 24 weeks (or end of study)

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.

Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
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.

Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
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)

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Baseline (randomization) and then 8 weeks

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.

Change from baseline to final visit in the YMRS total score
Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
Baseline to Week 9

MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Randomization to Week 9

HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
To evaluate the efficacy of quetiapine fumarate sustained release
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
Change from randomization in the HAM-A total score at Day 57
Time from randomisation to occurrence of an anxiety event
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Effectiveness of quetiapine fumarate used as monotherapy in treatment of symptoms of acute mania in patients with bipolar disorder by evaluation of the change from baseline in YMRS total score at Day 28 using the last observation carried forward method
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Symptom Checklist 90 scale (SCL-90-R)
8 weeks
The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
Time from randomization to recurrence of a mood event
Clinical Administered PTSD Scale (CAPS2)
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
from randomisation to any visit
The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Proportion of patients with moderate and severe adverse events
Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42
Incidence and Nature of Adverse Events (AEs)
from open label to week 26+ 30 days

Number of participants that had AE which occurred from first dose date to last dose date + 30 days.

Number of Patients Withdrawn Due to AEs.
during 26 weeks of treatment

Number of subjects who withdrew from the study due to AEs.

Changes in Laboratory Test Results (Prolactin)
Duration of study participation

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.

Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
OL baseline to week 26

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.

Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
26 weeks of treatment

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.

Change From Baseline in Weight
26 weeks of treatment

Number with 7% or more increase (without adjustment for normal growth)

Change From Baseline in Supine Pulse
OL baseline to week 26

Change from OL baseline to week 26 in supine pulse (bpm)

Change From OL Baseline in Supine Systolic BP.
OL baseline to Week 26

Changes from OL baseline to the final visits in Supine systolic BP (mmHg)

Change From OL Baseline in Supine Diastolic BP.
OL baseline to Week 26

Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)

Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Change in manic symptoms (as measured by Young Mania Rating Scale)
baseline to endpoint
To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
Twice weekly
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
VAS-Anxiety
on study day
The Montgomery-Asberg Depression Scale (MADRS) score
Visit 1 - > 5
To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
assessed at each visit for 8 weeks
The change in Yale Brown obsessive compulsive scale (Y-BOCS) from baseline to week 10 and the number of responders are the primary efficacy parameters.
Criteria for response will be a 25% or greater change from baseline on the Y-BOCS and a final CGI rating of "much improved or "very much improved".
single dose PK parameters(300mg)
Day1 to 48 hour after Day 5
Steady-state multiple doses PK parameters
Day 1 to 48 hours after Day7
Positron emission tomography using the radioligand [11C]raclopride
5 visits

Secondary Endpoints

Young Mania Rating Scale (YMRS)
12 weeks
Secondary Efficacy Measures
CDRS response rate: Defined by a > 50% decrease from baseline to endpoint in CDRS total score.
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Study Design & Arms

AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QuetiapineEXPERIMENTALPatients 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).
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Quetiapine Extended ReleaseEXPERIMENTALLithium or valproate at stable doses within seric therapeutic levels
SertralineACTIVE_COMPARATORLithium or valproate at stable doses within seric therapeutic levels
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)EXPERIMENTALQuetiapine 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-ChlorpromazineACTIVE_COMPARATORChlorpromazine (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 XREXPERIMENTALQuetiapine 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 carbonateEXPERIMENTALQuetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Quetiapine XREXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Add-on Quetiapine XR+SSRI/VenlafaxineACTIVE_COMPARATORSelective 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/VenlafaxineACTIVE_COMPARATORSelective 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 XRACTIVE_COMPARATORSwitch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
3PLACEBO_COMPARATOREquivalent number of placebo oral tablets taken daily for 8 weeks.
RisperidoneACTIVE_COMPARATOR -
Quetapine XREXPERIMENTALTablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
AEXPERIMENTALQuetiapine at dosage of 50 to 150 mg

Interventions

NameTypeDescription
quetiapineDRUG100mg 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).
Quetiapine Fumarate (SEROQUEL) Extended ReleaseDRUGQuetiapine 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.
PlaceboDRUGPlacebo 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)DRUGFlexible 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.
SertralineDRUGFlexible 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 stabilizerDRUGAn 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)DRUG200 mg or 300 mg, oral, single dose
ChlorpromazineDRUG50 mg, oral, double dose
Quetiapine fumarate XRDRUGQuetiapine 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 carbonateDRUGTwice 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 XRDRUGOral treatment with 150 up to 300 mg/day once daily in the evening
SSRI/VenlafaxineDRUGSSRI - doses within label, Venlafaxine dose up to 225 mg/day
SeroquelDRUGseroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks
Sugar PillDRUGSugar pill to match seroquel
quetiapine extended-releaseDRUGSeroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
Quetiapine Fumarate Extended- ReleaseDRUGOpen-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 ReleaseDRUGUptitrated 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
RisperidoneDRUGUptitrated 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) SRDRUG -
Quetiapine fumarateDRUG -
ParoxetineDRUG -
Quetiapine SRDRUG -
EscitalopramDRUG -
AmitriptylineDRUG -
BupropionDRUG -
CitalopramDRUG -
DuloxetineDRUG -
FluoxetineDRUG -
VenlafaxineDRUG -
Escitalopram oxylateDRUG -
lithiumDRUG -
divalproexDRUG -
quetiapine fumarate (Seroquel)DRUG -
mood stabilizing activityBEHAVIORAL -
Seroquel (quetiapine)DRUG -
quetiapine fumarate placeboDRUGoral 0 mg
Seroquel SRDRUG -
quetiapine fumarate tabletsDRUG -
Seroquel®, quetiapine fumarate (atypical antipsychotic)DRUG -
lithium (mood stabilizer)DRUG -
divalproex (mood stabilizer)DRUG -
SEROQUEL (quetiapine fumarate) TabletsDRUG -
SSRI/ClomipramineDRUG -
quetiapine fumarate extended-releaseDRUG200mg,oral,single dose
SEROQUEL XR (quetiapine)DRUGrepeated dose of oral tablets, 8 times per subject
SEROQUEL IR (quetiapine)DRUGrepeated dose of oral tablets, 4 times per subject
radioligand [11C]racloprideDRUGsingle dose of iv admin, 5 times per subject
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Eligibility Criteria

Age Range12 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United StatesChinaSpainArgentinaBrazilChileColombiaGuatemalaMexicoPeruTurkey (Türkiye)VenezuelaIndiaSerbiaSouth AfricaTaiwanAustraliaAustriaBelgiumBulgariaDenmarkGermanyHungaryItalyPortugalRomaniaSlovakiaUnited KingdomCanadaHong KongSouth KoreaCosta RicaFinlandRussiaSwitzerlandEstoniaUkrainePolandCzechiaFranceNorwaySwedenMalaysiaPhilippinesIndonesiaGreeceLithuaniaThailandLatviaNetherlands
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Frequently asked questions about SEROQUEL

What is SEROQUEL used for?

SEROQUEL is an atypical antipsychotic studied in bipolar disorder, depression, schizophrenia, and social anxiety disorder. It is a small molecule developed by AstraZeneca PLC. The clinical program includes completed Phase 3 trials in schizophrenia and social anxiety disorder, plus a Phase 1 PET study in depression.

Who makes SEROQUEL?

SEROQUEL is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer of the SEROQUEL and SEROQUEL XR product families, including quetiapine fumarate tablets.

What phase is SEROQUEL in?

SEROQUEL has completed Phase 3 clinical development across its studied indications, including schizophrenia and social anxiety disorder. The program also includes a completed Phase 1 PET imaging study. All listed trials are completed, with no active trials currently recorded.

What clinical trials is SEROQUEL in?

SEROQUEL has completed trials including NCT00234377, a Phase 3 switching study in schizophrenia with 550 patients across Canada, Finland, Germany, and Hungary; NCT00228462, a Phase 3 relapse prevention study in chronic schizophrenia with 197 patients; NCT00773162, a Phase 3 study in social anxiety disorder; and NCT00832221, a Phase 1 PET study in depression.

Is SEROQUEL the same as quetiapine?

Yes, SEROQUEL is a brand name for quetiapine, specifically quetiapine fumarate. It is also marketed as SEROQUEL XR, an extended-release formulation, and has been referred to as Seroquel SR. These names all refer to the same atypical antipsychotic developed by AstraZeneca.

What does SEROQUEL target?

SEROQUEL, or quetiapine, is an atypical antipsychotic small molecule. Its central D2 dopamine receptor occupancy was directly assessed in the completed Phase 1 PET study NCT00832221 using [11C]raclopride, which measured D2 dopamine occupancy in the brain.