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Floxin IV |
Clinical Trial: A Study to Determine the Effectiveness and Safety of Risperidone in the Prevention of Bipolar Mood Episodes
This study is currently recruiting patients.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. August 2005
|
Purpose
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in subjects with bipolar 1 disorder.
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Risperidone Long Acting Injection | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Risperidone Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, with Open-Label Extension
Further Study Details:
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Diagnosis of bipolar I disorder, currently experiencing a mixed or manic episode or stable,
- Two or more bipolar mood episodes in the last 2 years excluding current episode
- Females must have a negative pregnancy test
Exclusion Criteria:
- History of more that 4 mood episodes a year during the last two years
- Experiencing a depressive episode
- Antisocial or borderline personality disorder
- Has unstable or serious general medical illness
- Has received medications disallowed by study criteria
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00132678
California
National City, California, United States; Recruiting
Study Contact 619-327-0155
Oceanside, California, United States; Recruiting
Study Contact 760-631-3056
District of Columbia
Washington, District of Columbia, 20016, United States; Recruiting
Study Contact 202-885-5725
Florida
Hialeah, Florida, 30016, United States; Recruiting
Study Contact 305-702-9453
Brandenton, Florida, United States; Recruiting
Study Contact 941-782-4628
Louisiana
Lake Charles, Louisiana, 70601, United States; Recruiting
Study Contact 337-494-3266
New Jersey
Clementon, New Jersey, United States; Recruiting
Study Contact 856-566-9000 Ext. 220
Oklahoma
Oklahoma City, Oklahoma, 73103, United States; Recruiting
Study Contact 405-235-8188
Texas
Desoto, Texas, 75115, United States; Recruiting
Study Contact 972-283-6286
Virginia
Richmond, Virginia, United States; Recruiting
Study Contact 804-270-6811
Washington
Seattle, Washington, 98133, United States; Recruiting
Study Contact 206-363-7464 Ext. 119
Austria
Peishingerstrasse, Austria; Recruiting
Study Contact, Prof, MD 43-2635-602-3200
Voecklabruck, Austria; Recruiting
Study Contact, MD 43-7672-700-26500
India, Hyderabad
Banjara Hills, Hyderabad, 500 034, India; Recruiting
Study Contact 91-40-55752222
India, Manipal
Karnataka, Manipal, 576104, India; Recruiting
Study Contact 91-820-2571935
Malaysia
Tampoi, Malaysia; Recruiting
Study Contact 60-7-236-1743
Kelantan, Malaysia; Recruiting
Study Contact 60-9-750-2290
Kuala Lumpur, Malaysia; Recruiting
Study Contact 603-79570995
Poland
Gdansk, Poland; Recruiting
Study Contact, MD 48-58-3446085
Choroszcz, Poland; Recruiting
Study Contact, MD 48-85-7191091 Ext. 223
Swiecie, Poland; Recruiting
Study Contact, MD 48-52-3333287
Lipno, Poland; Recruiting
Study Contact 48-54-2873259
Tuszyn, Poland; Recruiting
Study Contact, MD 48-602305132
Lodz, Poland; Recruiting
Study Contact 48-42-6529639
Russian Federation
Leningradsky Region, Russian Federation; Recruiting
Study Contact 7-813-71-132-64
Moscow, Russian Federation; Recruiting
Study Contact 7-095-952-83-31
St Petersburg, Russian Federation; Recruiting
Study Contact 7-812-567-7217
Moscow, Russian Federation; Recruiting
Study Contact 7-095-116-5183
SARATOV, Russian Federation; Recruiting
Study Contact 7-8452-224031
St Petersburg, Russian Federation; Recruiting
Study Contact 7-812-114-7635
Samara, Russian Federation; Recruiting
Study Contact 7-8462-51-15-72
Moscow, Russian Federation; Recruiting
Study Contact 7-095-116-90-83
St Petersburg, Russian Federation; Recruiting
Study Contact 7-812-274-38-69
Moscow, Russian Federation; Recruiting
Study Contact 7-095-193-1132
Slovakia
Slovak Republic, Slovakia; Recruiting
Study Contact 421-55-615-2735
Rimavska Sobota, Slovakia; Recruiting
Study Contact 421-905-205-178
Slovakia, Slovak Republic
Bratislava, Slovak Republic, Slovakia; Recruiting
Study Contact 421-2-43339500 Ext. 402
Spain
Madrid, Spain; Recruiting
Study Contact 34-91-316-22-40
Barcelona, Spain; Recruiting
Study Contact 34-93-227-54-01
Taiwan
Tainan, Taiwan; Recruiting
Study Contact 886-6-2353535
Kuei-San,Tao-yuan, Taiwan; Recruiting
Study Contact 886-3-3281200
Taipei, Taiwan; Recruiting
Study Contact 886-2-8792-7431
Taichung, Taiwan; Recruiting
Study Contact 886-4-22062121
Ukraine
Dnepropetrvsk, Ukraine; Recruiting
Study Contact 380-562-268656
Lvov, Ukraine; Recruiting
Study Contact 38-0322-920650
Simferopol, Ukraine; Recruiting
Study Contact 38-065-2276318
Dnepropetrovsk, Ukraine; Recruiting
Study Contact 38-0562-471716
Kiev, Ukraine; Recruiting
Study Contact 38 044543 88 20
Odessa, Ukraine; Recruiting
Study Contact 38 0482 302150
Kharkov, Ukraine; Recruiting
Study Contact 38 957 7383225
More Information
Study ID Numbers: RIS-BIM-3003
Last Updated: August 19, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00132678
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00132678
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Floxin IV (Drug Digest)
- Ofloxacin Injection (Drug Digest)
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