Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

NCT00731549 | Completed Phase 3 Results DMC

• 1 other identifier: 31-08-248
• Study Type: interventional
• Target: 1,081
• Locations: 26 countries
• Sites: 204

Brief Summary

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Aripiprazole; IM Depot; Schizophrenia; Intramuscular

Outcome Measures

Primary Outcomes (1)

• Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).

  "Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.

  Baseline to Week 52/Last visit

Secondary Outcomes (9)

• Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.

  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)

• Percentage of Participants Achieving Remission.

  Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52

• Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.

  Baseline to Week 28

• Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.

  Baseline to Week 52

• Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.

  Baseline, Weeks 12, 24, 52 and last visit

Study Arms (1)

1

EXPERIMENTAL

Active Treatment of aripiprazole IM depot (300mg or 400mg)

Drug: Aripiprazole IM Depot

Interventions

Aripiprazole IM Depot DRUG

300mg or 400mg

Also known as: Oral Aripiprazole

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Covance: collaborator

Study Sites (214)

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Chandler, Arizona, 85226, United States

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Anaheim, California, 92804, United States

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Cerritos, California, 90703, United States

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Chino, California, 91710, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91204, United States

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Glendale, California, 91206, United States

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Imperial, California, 92251, United States

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La Habra, California, 90631, United States

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Los Angeles, California, 90024, United States

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National City, California, 91950, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Pasadena, California, 91106, United States

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Pico Rivera, California, 90660, United States

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San Bernardino, California, 92408, United States

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San Diego, California, 92102, United States

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San Diego, California, 92103, United States

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Study Site

San Diego, California, 92123, United States

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San Diego, California, 92123, United States

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Sherman Oaks, California, 91403, United States

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Torrance, California, 90502, United States

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Highlands Ranch, Colorado, 80130, United States

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Norwalk, Connecticut, 06851, United States

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Washington D.C., District of Columbia, 20016, United States

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Bradenton, Florida, 34208, United States

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Coral Springs, Florida, 33065, United States

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Doral, Florida, 33166, United States

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Gainesville, Florida, 32606, United States

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Hollywood, Florida, 33021, United States

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Kissimmee, Florida, 34741, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33135, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32839, United States

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Plantation, Florida, 33317, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30328, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60640, United States

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Hoffman Estates, Illinois, 60169, United States

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Oak Brook, Illinois, 60523, United States

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Indianapolis, Indiana, 46222, United States

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Baton Rouge, Louisiana, 70808, United States

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Baton Rouge, Louisiana, 70809, United States

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Lake Charles, Louisiana, 70629, United States

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New Orleans, Louisiana, 70115, United States

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Shreveport, Louisiana, 71101, United States

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Columbia, Maryland, 21045, United States

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Flowood, Mississippi, 39232, United States

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Kansas City, Missouri, 64108, United States

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St Louis, Missouri, 63109, United States

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St Louis, Missouri, 63118, United States

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North Platte, Nebraska, 69101, United States

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Albuquerque, New Mexico, 87131, United States

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Buffalo, New York, 14213, United States

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Buffalo, New York, 14215, United States

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Cedarhurst, New York, 11516, United States

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Holliswood, New York, 11423, United States

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Jamaica, New York, 11418, United States

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New York, New York, 10003, United States

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New York, New York, 10027, United States

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Rochester, New York, 14615, United States

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Hickory, North Carolina, 28601, United States

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Winston-Salem, North Carolina, 27104, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44109, United States

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Garfield Heights, Ohio, 44125, United States

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Middleburg Heights, Ohio, 44130, United States

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Toledo, Ohio, 43609, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oklahoma City, Oklahoma, 73139, United States

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Allentown, Pennsylvania, 18104, United States

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Jenkintown, Pennsylvania, 19046, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19131, United States

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Philadelphia, Pennsylvania, 19139, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sellersville, Pennsylvania, 18960, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29425, United States

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Johnson City, Tennessee, 37614-1707, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37212, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78754, United States

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DeSoto, Texas, 75115, United States

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Richmond, Virginia, 23230, United States

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Bellevue, Washington, 98007, United States

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Bothell, Washington, 98011, United States

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Spokane, Washington, 99204, United States

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Milwaukee, Wisconsin, 53226, United States

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Buenos Aires, C1058AAJ, Argentina

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Buenos Aires, C1405BOA, Argentina

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Buenos Aires, C1425AHQ, Argentina

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Cordoba, Cordoba, X5009BIN, Argentina

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La Plata, Buenos Aires, Argentina

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Mendoza, 5500HYF, Argentina

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Dandenong, Victoria, 3175, Australia

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Epping, Victoria, 3076, Australia

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Frankston, Victoria, 3199, Australia

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Fremantle, Western Australia, 6959, Australia

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Glenside, SA, 5063, Australia

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Melbourne, VIC 3004, Australia

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Innsbruck, A-6020, Austria

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Bruges, 8200, Belgium

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Burgas, 8000, Bulgaria

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Lovech, 5500, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Radnevo, 6260, Bulgaria

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Rousse, 7003, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1632, Bulgaria

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Varna, 9001, Bulgaria

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Veliko Tarnovo, 5007, Bulgaria

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San Bernardo, Santiago, 8780000, Chile

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Santiago, 7500710, Chile

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Santiago, 7510186, Chile

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Santiago, 7580307, Chile

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Santiago, 8330838, Chile

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Santiago, 8900085, Chile

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Santiago, Chile

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Zagreb, 10 090, Croatia

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Zagreb, 10000, Croatia

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Jämejala, 71024, Estonia

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Tallinn, 10614, Estonia

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Tallinn, 10617, Estonia

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Tartu, 50406, Estonia

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Helsinki, 00250, Finland

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Élancourt, 78990, France

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Rennes, 35703, France

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Saint-Nazaire, 44606, France

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Baja, 6500, Hungary

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Balassagyarmat, 2660, Hungary

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Cegléd, 2700, Hungary

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Győr, 9023, Hungary

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Ahmedabad, Gujarat, 380006, India

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Bangalore, Karnataka, 560010, India

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Chennai, Tamil Nadu, 600003, India

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Kanpur, 208005, India

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Mangalore, 575018, India

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Pune, 411004, India

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Tirupati, 517507, India

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Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

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Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

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Tanjong Rambutan, Perak, 31250, Malaysia

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Kuala Selangor, 43000, Malaysia

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Guadalajara, Jalisco, 44280, Mexico

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Mexico City, Mexico City, 6700, Mexico

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Monterrey, Nuevo León, 64040, Mexico

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San Luis Potosí City, San Luis Potosí, 78218, Mexico

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Culiacán, Sinaloa, 80020, Mexico

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Ålesund, 6018, Norway

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Klepp stasjon, 4353, Norway

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Bataan, Central Luzon, 2105, Philippines

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Mandaluyong, NCR, 1553, Philippines

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Quezon City, NCR, 1104, Philippines

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Iloilo City, Western Visayas, 5000, Philippines

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Bełchatów, 97-400, Poland

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Bialystok, 15-879, Poland

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Bydgoszcz, 85096, Poland

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Choroszcz, 16-070, Poland

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Krakow, 31-501, Poland

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Leszno, 64-100, Poland

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Pruszków, 05-802, Poland

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Sosnowiec, 41-200, Poland

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Wroclaw, 50-227, Poland

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San Juan, 00918, Puerto Rico

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Arad, 310022, Romania

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Bucharest, 041914, Romania

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Cluj-Napoca, 400012, Romania

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Craiova, 200620, Romania

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Oradea, 410154, Romania

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Piteşti, 110069, Romania

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Lipetsk, 398007, Russia

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Moscow, 115522, Russia

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Moscow, 127083, Russia

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Nizhny Novgorod, 603152, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 188357, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Smolensk, 214019, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Košice, 041 90, Slovakia

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Liptovský Mikuláš, 3101, Slovakia

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Prešov, 8001, Slovakia

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Rimavská Sobota, 97901, Slovakia

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Svidník, 089 01, Slovakia

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Pretoria, Gauteng, 0001, South Africa

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Cape Town, Western Province, 7530, South Africa

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Busan, 614-735, South Korea

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Deajeon, 301-721, South Korea

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Gwangju, 501-757, South Korea

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Joong-gu, Incheon, 400-700, South Korea

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Seoul, 110-744, South Korea

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Seoul, 137-701, South Korea

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Seoul, 150-950, South Korea

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Barcelona, 08036, Spain

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Barcelona, 08907, Spain

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Barcelona, 8005, Spain

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Tainan, 704, Taiwan

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Taipei, 11086, Taiwan

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Muang, Chiangmai, 50100, Thailand

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Muang, Chiangmai, 50200, Thailand

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Bangkok, 10330, Thailand

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MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 11, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 26, 2014
• Results First Posted: November 11, 2014

Record last verified: 2014-11

Locations

FI (1); BE (1); PR (1); SE (2); ZA (2); HU (4); ME (5); CL (7); AU (1); FR (3); RO (6); MY (4); ES (3); RU (9); CR (2); PH (4); KR (7); TW (2); TH (3); SL (5); AR (6); PL (9); NO (2); IN (7); US (96); BU (12)