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Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy (RELEASE)

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ClinicalTrials.gov Identifier: NCT01128114
Recruitment Status : Terminated (Poor recruitment)
First Posted : May 21, 2010
Results First Posted : April 10, 2012
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.

Condition or disease Intervention/treatment Phase
Acute Bipolar Mania Drug: Quetiapine fumarate (Seroquel XR) Phase 4

Detailed Description:
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Quetiapine XR
Quetiapine fumarate (Seroquel XR)
 Drug: Quetiapine fumarate (Seroquel XR)
Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.
Other Name: Seroquel XR tablet


Outcome Measures
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Primary Outcome Measures :
  1. The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF) [ Time Frame: Baseline, week 4 ]
    CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.


Secondary Outcome Measures :
  1. The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score [ Time Frame: Baseline, week 4 ]
    The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.

  2. The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4 [ Time Frame: Baseline, week 4 ]
    The Global Improvement scale (CGI-I) is scored to rate the patient's change from baseline CGI. A CGI-I score of 1 indicates that a patient is "very much improved" and a score of 7 indicates that a patient is "very much worse." CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29

  3. The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score [ Time Frame: Baseline, week 4 ]
    The CGI-S is scored to rate patient's current clinical state. At enrolment patient's condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is "Normal, not at all ill" and a score of 7 indicates that a patient is "Among the most extremely ill patients".


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)
  • Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry

Exclusion Criteria:

  • Non-response to antipsychotic treatments for manic symptoms in previous episodes
  • A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1. Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%, 2. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
  • An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01128114


Locations
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Korea, Republic of
Research Site
Chunan, Choongnam, Korea, Republic of
Research Site
CheonAn, Chungcheongnam-do, Korea, Republic of
Research Site
Chuncheon, Gangwondo, Korea, Republic of
Research Site
Bucheon, Gueonggido, Korea, Republic of
Research Site
Suwon, Gyeonggi-do, Korea, Republic of
Research Site
Gyeongju, Gyeongsangbuk-do, Korea, Republic of
Research Site
Yongsan-gu, Seoul, Korea, Republic of
Research Site
Daejeon, Korea, Republic of
Research Site
Gyungbook, Korea, Republic of
Research Site
Naju, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Joon Woo Bahn AstraZeneca
Principal Investigator: Won-Myong Bahk, MD St.Mary's hospital, The Catholic University of Korea
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01128114    
Other Study ID Numbers: D1443L00080
First Posted: May 21, 2010    Key Record Dates
Results First Posted: April 10, 2012
Last Update Posted: April 17, 2012
Last Verified: April 2012
Keywords provided by AstraZeneca:
Acute bipolar mania
Seroquel XR
Quetiapine fumarate
Add-on therapy
Additional relevant MeSH terms:
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Mania
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Quetiapine Fumarate
Antidepressive Agents
 Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs