Clinical trial NCT00731549: Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Official title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Aripiprazole
IM Depot
Schizophrenia
Intramuscular
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2008-08-11
Enrollment: 1081
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: To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Detailed description: This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. 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., 31-07-246 or 31-07-247).

This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.

During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.

Eligibility criteria: Inclusion Criteria:

* Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
* Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
* Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
* # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
* Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

Exclusion Criteria:

* Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
* Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
* Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
* Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
* Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
* Subjects with a history of hypersensitivity to antipsychotic agents.
* Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

Primary outcomes:
measure: Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
timeFrame: Baseline to Week 52/Last visit
Secondary outcomes:
measure: Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
timeFrame: Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)
measure: Percentage of Participants Achieving Remission.
timeFrame: Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
measure: Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
timeFrame: Baseline to Week 28
measure: Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline, Weeks 12, 24, 52 and last visit
measure: Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
timeFrame: Baseline, Weeks 12, 24, 52 and last visit
measure: Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
timeFrame: Baseline, Weeks 12, 24, 52 and last visit
measure: Mean Clinical Global Impression of Improvement (CGI-I) Score.
timeFrame: Weeks 2, 4, 12, 24, 52 and last visit
measure: Percentage of Participants Who Discontinued Due to All Causes.
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Chino
country: United States
state: California
city: Escondido
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Glendale
country: United States
state: California
city: Imperial
country: United States
state: California
city: La Habra
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: National City
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Torrance
country: United States
state: California
city: Highlands Ranch
country: United States
state: Colorado
city: Norwalk
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Doral
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state: Florida
city: Gainesville
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state: Florida
city: Hollywood
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state: Florida
city: Kissimmee
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami
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state: Florida
city: Orange City
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state: Florida
city: Orlando
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state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
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state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
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state: Illinois
city: Chicago
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state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Oak Brook
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state: Illinois
city: Indianapolis
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state: Indiana
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state: Louisiana
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state: Louisiana
city: Lake Charles
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city: New Orleans
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state: Maryland
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state: Mississippi
city: Kansas City
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state: Missouri
city: St. Louis
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state: Missouri
city: St. Louis
country: United States
state: Missouri
city: North Platte
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state: Nebraska
city: Albuquerque
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state: New Mexico
city: Buffalo
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state: New York
city: Buffalo
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state: New York
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city: Holliswood
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state: New York
city: Jamaica
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city: New York
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state: North Carolina
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city: Garfield Heights
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state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Oklahoma City
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state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Media
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
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city: Pittsburgh
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state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Charleston
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state: South Carolina
city: Charleston
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state: South Carolina
city: Charleston
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state: South Carolina
city: Johnson City
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state: Tennessee
city: Memphis
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state: Tennessee
city: Nashville
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state: Tennessee
city: Austin
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state: Texas
city: Austin
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state: Texas
city: DeSoto
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state: Texas
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Bothell
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Cordoba, Cordoba
country: Argentina
city: La Plata, Buenos Aires
country: Argentina
city: Mendoza
country: Argentina
city: Dandenong
country: Australia
state: Victoria
city: Epping
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Glenside, SA
country: Australia
city: Melbourne
country: Australia
city: Innsbruck
country: Austria
city: Brugge
country: Belgium
city: Bourgas
country: Bulgaria
city: Lovech
country: Bulgaria
city: Pazardjik
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Radnevo
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: San Bernardo, Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Jamejala
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Helsinki
country: Finland
city: Elancourt
country: France
city: Rennes
country: France
city: St. Nazaire
country: France
city: Baja
country: Hungary
city: Balassagyarmat
country: Hungary
city: Cegléd
country: Hungary
city: Gyor
country: Hungary
city: Ahmedabad
country: India
state: Gujarat
city: Bangalore
country: India
state: Karnataka
city: Chennai
country: India
state: Tamil Nadu
city: Kanpur
country: India
city: Mangalore
country: India
city: Pune
country: India
city: Tirupati
country: India
city: Busan
country: Korea, Republic of
city: Deajeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Joong-gu, Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Tanjong Rambutan
country: Malaysia
state: Perak
city: Kuala Lumpur
country: Malaysia
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
state: Wilayah Persekutuan
city: Selangor
country: Malaysia
city: Mexico
country: Mexico
state: DF
city: Guadalajara
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo León
city: Culiacan
country: Mexico
state: Sinaloa
city: San Luis Potosí
country: Mexico
city: Aalesund
country: Norway
city: Klepp stasjon
country: Norway
city: Bataan
country: Philippines
state: Central Luzon
city: Mandaluyong
country: Philippines
state: NCR
city: Quezon City
country: Philippines
state: NCR
city: Iloilo
country: Philippines
state: Western Visayas
city: Belchatow
country: Poland
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Choroszcz
country: Poland
city: Kraków
country: Poland
city: Leszno
country: Poland
city: Pruszkow
country: Poland
city: Sosnowiec
country: Poland
city: Wroclaw
country: Poland
city: San Juan
country: Puerto Rico
city: Arad
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Oradea
country: Romania
city: Pitesti
country: Romania
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Kosice
country: Slovakia
city: Liptovsky Mikulas
country: Slovakia
city: Presov
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Svidnik
country: Slovakia
city: Pretoria
country: South Africa
state: Gauteng
city: Cape Town
country: South Africa
state: Western Province
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Muang
country: Thailand
state: Chiangmai
city: Muang
country: Thailand
state: Chiangmai
city: Bangkok
country: Thailand
Study officials:
References: