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Adult Bipolar Mania

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Mania

Intervention: Quetiapine fumarate XR (Drug); Lithium (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Castiglione, Study Director, Affiliation: AstraZeneca
Michel Bourin, Professeur, Principal Investigator, Affiliation: Neurobiologie de l'anxiété et de la dépression Faculté de Médecine

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)

Secondary outcome:

The Number of Patients With Clinically Significant Response.

Remission

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 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)

Improvement of Overall Bipolar Illness

Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score

Change From Baseline to Day 43 in PANSS Activation Subscale Score

Change From Baseline to Day 43 in PANSS Positive Subscale Score

Change From Baseline to Day 43 in Each YMRS Item Score No. 1

Change From Baseline to Day 43 in Each YMRS Item Score No. 2

Change From Baseline to Day 43 in Each YMRS Item Score No. 3

Change From Baseline to Day 43 in Each YMRS Item Score No. 4

Change From Baseline to Day 43 in Each YMRS Item Score No. 5

Change From Baseline to Day 43 in Each YMRS Item Score No. 6

Change From Baseline to Day 43 in Each YMRS Item Score No. 7

Change From Baseline to Day 43 in Each YMRS Item Score No. 8

Change From Baseline to Day 43 in Each YMRS Item Score No. 9

Change From Baseline to Day 43 in Each YMRS Item Score No. 10

Change From Baseline to Day 43 in Each YMRS Item Score No. 11

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Cedex, Belgium

Research Site, Dendermonde, Belgium

Research Site, Montignies-sur-sambre, Belgium

Research Site, Overpelt, Belgium

Research Site, Tournai, Belgium

Research Site, Burgas, Bulgaria

Research Site, Cedex, Bulgaria

Research Site, Kazanlak, Bulgaria

Research Site, Pazardjik, Bulgaria

Research Site, Plovdiv, Bulgaria

Research Site, Radnevo, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Berlin, Germany

Research Site, Cedex, Germany

Research Site, Mannheim, Germany

Research Site, Munchen, Germany

Research Site, Nurnberg, Germany

Research Site, Cedex, India

Research Site, Bat Yam, Israel

Research Site, Beer Ya'acov, Israel

Research Site, Cedex, Israel

Research Site, Haifa, Israel

Research Site, Petach-tikva, Israel

Research Site, Tel-hashomer, Israel

Research Site, Bydgoszcz, Poland

Research Site, Cedex, Poland

Research Site, Choroszcz, Poland

Research Site, Gorlice, Poland

Research Site, Katowice, Poland

Research Site, Krakow, Poland

Research Site, Lublin, Poland

Research Site, Poznan, Poland

Research Site, Arkhangelsk, Russian Federation

Research Site, Cedex, Russian Federation

Research Site, Chita, Russian Federation

Research Site, Kazan, Russian Federation

Research Site, Moscow, Russian Federation

Research Site, Saratov, Russian Federation

Research Site, St Petersburg, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Voronezh, Russian Federation

Research Site, Cape Town, South Africa

Research Site, Cedex, South Africa

Research Site, Johannesburg, South Africa

Research Site, Port Elizabeth, South Africa

Research Site, Cedex, Ukraine

Research Site, Dnipropetrovsk, Ukraine

Research Site, Donetsk, Ukraine

Research Site, Kharkov, Ukraine

Research Site, Kiev, Ukraine

Research Site, Odessa, Ukraine

Research Site, Vinnitsia, Ukraine

Research Site, Visakhapatnam, Andh Prad, India

Research Site, Berlin, BE, Germany

Research Site, Bloemfontein, Free State, South Africa

Research Site, Vereeniging, Free State, South Africa

Research Site, Ahmedabad, Gujarat, India

Research Site, Bangalore, Karna, India

Research Site, Mangalore, Karna, India

Research Site, Manipal, Karna, India

Research Site, Nashik, Mahara, India

Research Site, Koln, NW, Germany

Research Site, Jaipur, Rajasthan, India

Research Site, Kanpur, Uttar Prad, India

Research Site, Worcester, W Cape, South Africa

Additional Information

Starting date: June 2009
Last updated: March 27, 2012

Page last updated: August 23, 2015

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