- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710709
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder (ATLAS)
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
Study Overview
Detailed Description
This will be an open-label, uncontrolled study which will enroll subjects completing Study 31-08-250 and new subjects. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e 31-08-250).
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 4K9
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Ontario
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Chatham, Ontario, Canada, N7L 1C1
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Elancourt, France, 78990
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Limoges, France, 87025
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Nimes, France, 30900
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Toulouse, France, 31000
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Budapest, Hungary, H-1135
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Nyireghaza, Hungary, H-4400
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Vac, Hungary, H-2600
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Fukuoka, Japan, 814-0133
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Fukuoka, Japan, 819-0037
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Fukuoka, Japan, 830-0033
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Fukushima, Japan, 960-0102
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Fukushima, Japan, 961-0021
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Fukushima, Japan, 963-0207
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Gunma, Japan, 375-0017
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Gunma, Japan, 377-0055
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Ibaraki, Japan, 311-3193
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Ibaraki, Japan, 319-1221
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Iizuka, Japan, 820-0014
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Kanagawa, Japan, 216-8511
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Kanagawa, Japan, 221-0801
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Kanagawa, Japan, 223-0062
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Kanagawa, Japan, 225-0003
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Kanagawa, Japan, 238-0042
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Kanagawa, Japan, 259-1304
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Kochi, Japan, 783-8505
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Kouchi, Japan, 780-0062
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Kumamoto, Japan, 861-8002
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Nagano-ken, Japan, 380-8582
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Okayama, Japan, 700-0915
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Okinawa, Japan, 901-1105
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Okinawa, Japan, 901-2553
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Osaka, Japan, 567-0017
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Sapporo, Japan, 002-8029
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Shizuoka, Japan, 420-0839
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Tokyo, Japan, 151-0053
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Tokyo, Japan, 162-0843
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Tokyo, Japan, 170-0002
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Tokyo, Japan, 175-0091
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Tokyo, Japan, 175-0094
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Tokyo, Japan, 187-8551
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Yamagata, Japan, 992-0601
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Yatsushiro, Japan, 866-0043
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Ōsaka, Japan, 545-8586
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Ōsaka, Japan, 569-1041
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Ōsaka, Japan, 570-0005
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Ōsaka, Japan, 573-1183
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Ōsaka, Japan, 589-0011
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Goyang-si, Korea, Republic of, 10326
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Jeju City, Korea, Republic of, 690-767
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 139-711
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Johor, Malaysia, 31250
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Perak, Malaysia, 30450
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Sarawak, Malaysia, 93250
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Bydgoszcz, Poland, 85-001
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Chelmno, Poland, 86-200
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Choroszcz, Poland, 16-070
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Gdansk, Poland, 80-438
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Lublin, Poland, 20-109
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Pruszkow, Poland, 05-802
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Tuszyn, Poland, 95-080
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Bucharest, Romania, 010825
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Bucharest, Romania, 030455
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Bucharest, Romania, 041915
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Iași, Romania, 700282
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Targu Mures, Romania, 540096
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Târgovişte, Romania, 130086
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Taipei, Taiwan, 110
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Alabama
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Birmingham, Alabama, United States, 35226
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Arkansas
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Little Rock, Arkansas, United States, 72211
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Rogers, Arkansas, United States, 72758
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California
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Bellflower, California, United States, 90706
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Beverly Hills, California, United States, 90210
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Costa Mesa, California, United States, 92626
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Culver City, California, United States, 90230
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Garden Grove, California, United States, 92845
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Lemon Grove, California, United States, 91945
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Oakland, California, United States, 94607
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Orange, California, United States, 92868
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Pico Rivera, California, United States, 90660
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Riverside, California, United States, 92506
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San Diego, California, United States, 92102
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Temecula, California, United States, 92591
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Upland, California, United States, 91786
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Wildomar, California, United States, 92595
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Colorado
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Colorado Springs, Colorado, United States, 80910
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Florida
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Gainesville, Florida, United States, 32607
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32256
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Leesburg, Florida, United States, 34748
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Orlando, Florida, United States, 32801
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Tampa, Florida, United States, 33613
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Georgia
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Atlanta, Georgia, United States, 30331
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Decatur, Georgia, United States, 30030
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Smyrna, Georgia, United States, 30080
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Illinois
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Chicago, Illinois, United States, 60611
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Chicago, Illinois, United States, 60612
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Hinsdale, Illinois, United States, 60522
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Naperville, Illinois, United States, 60563
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Schaumburg, Illinois, United States, 60194
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Kansas
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Prairie Village, Kansas, United States, 66206
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Louisiana
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Lake Charles, Louisiana, United States, 70629
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Maryland
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Baltimore, Maryland, United States, 21208
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Gaithersburg, Maryland, United States, 20877
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Massachusetts
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Boston, Massachusetts, United States, 02131
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Missouri
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O'Fallon, Missouri, United States, 63368
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Saint Louis, Missouri, United States, 63128
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Nebraska
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Lincoln, Nebraska, United States, 68526
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New Jersey
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Berlin, New Jersey, United States, 08009
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Cherry Hill, New Jersey, United States, 08002
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New York
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Brooklyn, New York, United States, 11241
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Buffalo, New York, United States, 14215
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New York, New York, United States, 10003
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New York, New York, United States, 10023
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Rochester, New York, United States, 14618
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Rochester, New York, United States, 14615
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Staten Island, New York, United States, 10312
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Staten Island, New York, United States, 10305
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Ohio
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Cincinnati, Ohio, United States, 45219
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Oklahoma City, Oklahoma, United States, 73103
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Oklahoma City, Oklahoma, United States, 73118
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Oregon
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Portland, Oregon, United States, 97210
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
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Media, Pennsylvania, United States, 19063
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South Carolina
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Columbia, South Carolina, United States, 29201
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Tennessee
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Memphis, Tennessee, United States, 38119
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Texas
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Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78754
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Dallas, Texas, United States, 75243
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Plano, Texas, United States, 75093
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Plano, Texas, United States, 75074
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Sugar Land, Texas, United States, 77478
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Wichita Falls, Texas, United States, 76309
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Utah
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Orem, Utah, United States, 84058
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Salt Lake City, Utah, United States, 84106
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Virginia
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Richmond, Virginia, United States, 23230
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Washington
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Bellevue, Washington, United States, 98007
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Spokane, Washington, United States, 99204
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Wisconsin
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Middleton, Wisconsin, United States, 53562
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Completed participation in Trial 31-08-250
- 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:
- Experienced 9 or more mood episodes within the past year
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental
Aripiprazole, Intramuscular (IM) Depot
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400mg or 300mg, intramuscular injections every 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events
Time Frame: Up to Week 52
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).
AEs were assessed as a criteria for safety and tolerability.
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Up to Week 52
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Injection Site Pain Measured by the Visual Analog Scale (VAS)
Time Frame: Up to Week 52
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Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred.
Ratings ranged from 0 (no pain) to 100 (unbearably painful).
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Up to Week 52
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Number of Participants With Clinically Significant Abnormal Laboratory Test Results
Time Frame: Up to Week 52
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Standard safety variables to be analyzed included clinical laboratory tests.
Incidence of treatment emergent adverse events (TEAEs) of potential clinical relevance included abnormal values in serum chemistry, hematology, urinalysis, and other laboratory test that were identified based on pre-defined criteria.
Abnormal laboratory values in participants were reported as serious adverse event/adverse events (SAE/AEs) and are reported in the SAE/other AE section of this report.
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Up to Week 52
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Number of Participants With Clinically Significant Abnormal Vital Signs
Time Frame: Up to Week 52
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TEAEs of potential clinical relevance included abnormal values in body weight, systolic and diastolic blood pressure, heart rate, and body temperature that were identified based on pre-defined criteria.
Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.
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Up to Week 52
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)
Time Frame: Up to Week 52
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Twelve-lead ECGs were recorded at specified visits.
For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart.
Additional 12-lead ECGs were permitted to be obtained at the investigator's discretion and were to always be obtained in the event of an early termination.
The ECGs were evaluated at the investigational site to determine the participant's eligibility and to monitor safety during the trial.
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Up to Week 52
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Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS)
Time Frame: Baseline, Week 28, and Week 52
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AIMS: 10 items described dyskinesia signs; 0-absence/no awareness; 4-severe condition/severe distress.
Total score for Items 1-10 ranges from 0 to 40; a higher score reflects severe condition.
SAS:Consisted of 10 parkinsonism signs;1-no symptoms;5-severe.Total score for Items 1-10 ranges from 1 to 50;a higher score reflects severe condition.DIEPSS:A 9-item rating scale (8 assessed individual symptoms [4 categories of parkinsonism, akathisia, dystonia & dyskinesia]+1 assessed general severity) was used;0-no symptoms/normal, 4-severe.Total score (8 individual symptom items) was in range of 0 to 32 (a higher score reflects severe condition).BARS:Consisted of 4 items related to akathisia:objective observation, subjective feelings of restlessness, distress, global clinical evaluation.Only BARS global clinical assessment score has been presented and rated using scale:0-absence of symptoms;5-severe akathisia.Total BARS global score ranges from 0 to 5,a higher score reflects severe condition.
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Baseline, Week 28, and Week 52
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Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to Week 52
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Suicidality was monitored throughout the trial using the C-SSRS at every visit.
The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a post-baseline/ "Since Last Visit" evaluation that focused on suicidality since the last trial visit.
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Up to Week 52
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Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating
Time Frame: Up to Week 52
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Injection-site reactions were assessed by the investigator (or qualified designee) and the participant.
Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe) .
The participant indicated the degree of pain at the most recent injection site using a VAS.
Ratings ranged from 0 (no pain) to 100 (unbearably painful).
Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
These assessments occurred at trial visits where injections occurred (scheduled and unscheduled), beginning with the first dose of open-label aripiprazole IM depot administered at the final visit of the Oral Stabilization Phase and continued through the last injection prior to the end of the IM Depot Maintenance Phase/Early termination (ET) visit (ie, evaluations were not done at end of the IM Depot Maintenance Phase/ET visit).
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Up to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Remained Stable at End of Treatment in Phase C
Time Frame: Up to Week 52
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The secondary objective was to evaluate the efficacy, as measured by the percentage of stable participants at baseline who remained stable at the end of treatment in the IM depot maintenance phase, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to subjects with bipolar I disorder.
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Up to Week 52
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Joan Amatniek, MD, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 31-08-252
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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