Clinical trial NCT00931723: Adult Bipolar Mania
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Mania
Keywords: Acute Mania
Mania, Adults
Seroquel
Acute Mania in Adult Patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-07-02
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
timeFrame: Change in YMRS total score from baseline to Day 43.
Secondary outcomes:
measure: The Number of Patients With Clinically Significant Response.
timeFrame: 43 days (from baseline to Day 43)
measure: Remission
timeFrame: Days 8 to 43
measure: Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)
timeFrame: Change from baseline to Day 43.
measure: Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)
timeFrame: Change from baseline to Day 43
measure: Improvement of Overall Bipolar Illness
timeFrame: Day 43.
measure: Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Change from baseline to Day 43.
measure: Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in PANSS Activation Subscale Score
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in PANSS Positive Subscale Score
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 1
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 2
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 3
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 4
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 5
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 6
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 7
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 8
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 9
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 10
timeFrame: Change from baseline to Day 43
measure: Change From Baseline to Day 43 in Each YMRS Item Score No. 11
timeFrame: Change from baseline to Day 43
Other outcomes:
Locations:
city: Cedex
country: Belgium
facility: Research Site
city: Dendermonde
country: Belgium
facility: Research Site
city: Montignies-sur-sambre
country: Belgium
facility: Research Site
city: Overpelt
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Cedex
country: Bulgaria
facility: Research Site
city: Kazanlak
country: Bulgaria
facility: Research Site
city: Pazardjik
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Radnevo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
state: BE
city: Koln
country: Germany
facility: Research Site
state: NW
city: Berlin
country: Germany
facility: Research Site
city: Cedex
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Visakhapatnam
country: India
facility: Research Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karna
city: Mangalore
country: India
facility: Research Site
state: Karna
city: Manipal
country: India
facility: Research Site
state: Karna
city: Nashik
country: India
facility: Research Site
state: Mahara
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Kanpur
country: India
facility: Research Site
state: Uttar Prad
city: Cedex
country: India
facility: Research Site
city: Bat Yam
country: Israel
facility: Research Site
city: Beer Ya'acov
country: Israel
facility: Research Site
city: Cedex
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Petach-tikva
country: Israel
facility: Research Site
city: Tel-hashomer
country: Israel
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Cedex
country: Poland
facility: Research Site
city: Choroszcz
country: Poland
facility: Research Site
city: Gorlice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Cedex
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
state: Free State
city: Vereeniging
country: South Africa
facility: Research Site
state: Free State
city: Worcester
country: South Africa
facility: Research Site
state: W Cape
city: Cape Town
country: South Africa
facility: Research Site
city: Cedex
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Cedex
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkov
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Vinnitsia
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Michael Castiglione
role: STUDY_DIRECTOR
affiliation: Neurobiologie de l'anxiété et de la dépression Faculté de Médecine
name: Michel Bourin, Professeur
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.