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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I
Keywords: Aripiprazole, Intramuscular (IM) Depot, Bipolar
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2012-10-19
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to Week 52
measure: Injection Site Pain Measured by the Visual Analog Scale (VAS)
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Abnormal Laboratory Test Results
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Abnormal Vital Signs
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)
timeFrame: Up to Week 52
measure: 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)
timeFrame: Baseline, Week 28, and Week 52
measure: Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 52
measure: Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants Who Remained Stable at End of Treatment in Phase C
timeFrame: Up to Week 52
Other outcomes:
Locations:
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city: Chatham
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city: Elancourt
country: France
city: Limoges
country: France
city: Nimes
country: France
city: Toulouse
country: France
city: Budapest
country: Hungary
city: Nyireghaza
country: Hungary
city: Vac
country: Hungary
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Fukushima
country: Japan
city: Fukushima
country: Japan
city: Gunma
country: Japan
city: Gunma
country: Japan
city: Ibaraki
country: Japan
city: Ibaraki
country: Japan
city: Iizuka
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Kochi
country: Japan
city: Kouchi
country: Japan
city: Kumamoto
country: Japan
city: Nagano-ken
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Shizuoka
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Yamagata
country: Japan
city: Yatsushiro
country: Japan
city: Ōsaka
country: Japan
city: Ōsaka
country: Japan
city: Ōsaka
country: Japan
city: Ōsaka
country: Japan
city: Ōsaka
country: Japan
city: Goyang-si
country: Korea, Republic of
city: Jeju City
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Johor
country: Malaysia
city: Perak
country: Malaysia
city: Sarawak
country: Malaysia
city: Bydgoszcz
country: Poland
city: Chelmno
country: Poland
city: Choroszcz
country: Poland
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Pruszkow
country: Poland
city: Tuszyn
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Iași
country: Romania
city: Targu Mures
country: Romania
city: Târgovişte
country: Romania
city: Taipei
country: Taiwan
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
name: Joan Amatniek, MD
role: STUDY_DIRECTOR
References:
citation: 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.