Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
NCT ID: NCT01710709
Last Updated: 2018-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
748 participants
INTERVENTIONAL
2012-11-30
2016-12-31
Brief Summary
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Detailed Description
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This open-label study will be comprised of phases similar to the pivotal double-blind study (i.e. Study 250): a screening phase (if applicable), a conversion phase (Phase A, if applicable), an oral stabilization phase (Phase B, if applicable), and an IM depot open-label maintenance phase (Phase C). Phase C will be a minimum of 28 weeks up to a 52-week treatment period with a 4 week follow up period.
During Phase C (the open-label maintenance phase) rescue medication will be allowed for subjects who do not meet stability criteria. This analysis focuses on Phase C due to ClinicalTrials.gov system limitations.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Aripiprazole, Intramuscular (IM) Depot
Aripiprazole
400mg or 300mg, intramuscular injections every 4 weeks.
Interventions
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Aripiprazole
400mg or 300mg, intramuscular injections every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* De novo subjects not participating in Trial 31-08-250
* Subjects who are able to provide written informed consent.
* Male and female subjects 18 years of age or older at time of informed consent
* Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication for their bipolar I disorder and would benefit from extended treatment with a long-acting injectable formulation
* Subjects who have a recurrence of mood episode or exacerbations of mood symptoms when they are not receiving treatment for their bipolar I disorder or are noncompliant with treatment for their bipolar I disorder
* Have an outpatient status
Exclusion Criteria
* A current manic episode with a duration of \> 2 years
* Currently meet DSM-IV-TR criteria for substance abuse or substance dependence; this includes the abuse of alcohol and benzodiazepines, but excludes the use of caffeine and/or nicotine
* Hypothyroidism or hyperthyroidism, unless condition has been stabilized
* Diagnosed with epilepsy or a history of seizures
* Known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones
* Sexually active women of childbearing potential and sexually active men who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this trial and for 180 days following the last dose of trial medication
* Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
* Risk of committing suicide
* Abnormal laboratory test results, vital signs and ECG results
* Participated in any clinical trial other than Trial 250 with an investigational agent within the 30 days prior to screening
* Had electroconvulsive therapy (ECT) treatment during the current episode or within 3 months
* Subjects who have not met criteria for stabilization for 4 consecutive weeks
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joan Amatniek, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Bellflower, California, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Culver City, California, United States
Garden Grove, California, United States
Lemon Grove, California, United States
Oakland, California, United States
Orange, California, United States
Pico Rivera, California, United States
Riverside, California, United States
San Diego, California, United States
Temecula, California, United States
Upland, California, United States
Wildomar, California, United States
Colorado Springs, Colorado, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Naperville, Illinois, United States
Schaumburg, Illinois, United States
Prairie Village, Kansas, United States
Lake Charles, Louisiana, United States
Baltimore, Maryland, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
O'Fallon, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Berlin, New Jersey, United States
Cherry Hill, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Staten Island, New York, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Media, Pennsylvania, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Plano, Texas, United States
Plano, Texas, United States
Sugar Land, Texas, United States
Wichita Falls, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Spokane, Washington, United States
Middleton, Wisconsin, United States
Kentville, Nova Scotia, Canada
Chatham, Ontario, Canada
Élancourt, , France
Limoges, , France
Nîmes, , France
Toulouse, , France
Budapest, , Hungary
Nyireghaza, , Hungary
Vác, , Hungary
Fukuoka, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Fukushima, , Japan
Fukushima, , Japan
Fukushima, , Japan
Gunma, , Japan
Gunma, , Japan
Ibaraki, , Japan
Ibaraki, , Japan
Iizuka, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kochi, , Japan
Kouchi, , Japan
Kumamoto, , Japan
Nagano-ken, , Japan
Okayama, , Japan
Okinawa, , Japan
Okinawa, , Japan
Osaka, , Japan
Ōsaka, , Japan
Ōsaka, , Japan
Ōsaka, , Japan
Ōsaka, , Japan
Ōsaka, , Japan
Sapporo, , Japan
Shizuoka, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Yamagata, , Japan
Yatsushiro, , Japan
Johor Bahru, , Malaysia
Perak, , Malaysia
Sarawak, , Malaysia
Bydgoszcz, , Poland
Chełmno, , Poland
Choroszcz, , Poland
Gdansk, , Poland
Lublin, , Poland
Pruszków, , Poland
Tuszyn, , Poland
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Iași, , Romania
Târgovişte, , Romania
Târgu Mureş, , Romania
Goyang-si, , South Korea
Jeju City, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Taipei, , Taiwan
Countries
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References
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Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018 Jun 10;6(1):14. doi: 10.1186/s40345-018-0122-z.
Other Identifiers
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31-08-252
Identifier Type: -
Identifier Source: org_study_id
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