Adult Bipolar Mania
An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania
1 other identifier
interventional
356
9 countries
65
Brief Summary
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2009
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
April 19, 2012
CompletedApril 19, 2012
March 1, 2012
1.4 years
June 29, 2009
November 17, 2011
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Change in YMRS total score from baseline to Day 43.
Secondary Outcomes (20)
The Number of Patients With Clinically Significant Response.
43 days (from baseline to Day 43)
Remission
Days 8 to 43
Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)
Change from baseline to Day 43.
Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)
Change from baseline to Day 43
Improvement of Overall Bipolar Illness
Day 43.
- +15 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORSeroquel XR and Lithium
2
PLACEBO COMPARATORSeroquel XR and placebo
Interventions
Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
Eligibility Criteria
You may qualify if:
- Provision of informed consent before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
- Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
You may not qualify if:
- The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
- The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
- The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Quintiles, Inc.collaborator
Study Sites (65)
Research Site
Montignies-sur-Sambre, Belgium, Belgium
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Overpelt, Belgium, Belgium
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Cedex, Cedex, Belgium
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Dendermonde, Belgium
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Tournai, Belgium
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Burgas, Bulgaria, Bulgaria
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Radnevo, Bulgaria, Bulgaria
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Cedex, Cedex, Bulgaria
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Kazanlak, Bulgaria
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Pazardzhik, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Cedex, Cedex, Germany
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Cologne, North Rhine-Westphalia, Germany
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Berlin, State of Berlin, Germany
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Berlin, Germany
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Mannheim, Germany
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München, Germany
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Nuremberg, Germany
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Visakhapatnam, Andh Prad, India
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Cedex, Cedex, India
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Ahmedabad, Gujarat, India
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Bangalore, Karna, India
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Mangalore, Karna, India
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Manipal, Karna, India
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Nashik, Mahara, India
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Jaipur, Rajasthan, India
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Kanpur, Uttar Prad, India
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Cedex, Cedex, Israel
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Bat Yam, Israel
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Beer Ya'acov, Israel
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Haifa, Israel
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Petah Tikva, Israel
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Tel Litwinsky, Israel
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Cedex, Cedex, Poland
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Bydgoszcz, Poland, Poland
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Choroszcz, Poland, Poland
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Gorlice, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Poznan, Poland
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Cedex, Cedex, Russia
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Arkhangelsk, Russia
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Chita, Russia
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Kazan', Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Voronezh, Russia
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Cedex, Cedex, South Africa
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Bloemfontein, Free State, South Africa
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Vereeniging, Free State, South Africa
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Worcester, W Cape, South Africa
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Cape Town, South Africa
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Cedex, Cedex, Ukraine
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Kharkiv, Ukraine, Ukraine
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Kiev, Ukraine, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
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Vinnitsia, Ukraine
Related Publications (1)
Bourin MS, Severus E, Schronen JP, Gass P, Szamosi J, Eriksson H, Chandrashekar H. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study. Int J Bipolar Disord. 2014 Nov 8;2:14. doi: 10.1186/s40345-014-0014-9. eCollection 2014.
PMID: 25505693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Michael Castiglione
AstraZeneca
- PRINCIPAL INVESTIGATOR
Michel Bourin, Professeur
Neurobiologie de l'anxiété et de la dépression Faculté de Médecine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 2, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
April 19, 2012
Results First Posted
April 19, 2012
Record last verified: 2012-03