A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
NCT ID: NCT00839852
Last Updated: 2019-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2009-05-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cariprazine 1.5mg
Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Cariprazine
Cariprazine was supplied in capsules.
Interventions
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Cariprazine
Cariprazine was supplied in capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
* Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
* Patients must have a caregiver to ensure treatment compliance.
Exclusion Criteria
18 Years
61 Years
ALL
No
Sponsors
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Gedeon Richter Ltd.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Suresh Durgam, MD
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Locations
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Forest Investigative Site
Costa Mesa, California, United States
Forest Investigative Site
Long Beach, California, United States
Forest Investigative Site
Oceanside, California, United States
Forest Investigative Site
Paramount, California, United States
Forest Investigative Site
Riverside, California, United States
Forest Investigative Site
Washington D.C., District of Columbia, United States
Forest Investigative Site
Bradenton, Florida, United States
Forest Investigative Site
Kissimmee, Florida, United States
Forest Investigative Site
Lake Charles, Louisiana, United States
Forest Investigative Site
Baltimore, Maryland, United States
Forest Investigative Site
Flowood, Mississippi, United States
Forest Investigative Site
Creve Coeur, Missouri, United States
Forest Investigative Site
Cincinnati, Ohio, United States
Forest Investigative Site
Charleston, South Carolina, United States
Forest Investigative Site
Memphis, Tennessee, United States
Forest Investigative Site
Houston, Texas, United States
Forest Investigative Site
Irving, Texas, United States
Forest Investigative Site
Vijaywada, Andh Prad, India
Forest Investigative Site
Visakhapatnam, Andh Prad, India
Forest Investigative Site
Ahmedabad, Gujarat, India
Forest Investigative Site
Ahmedabad, Gujarat, India
Forest Investigative Site
Bangalore, Karna, India
Forest Investigative Site
Bangalore, Karna, India
Forest Investigative Site
Mangalore, Karna, India
Forest Investigative Site
Mangalore, Karna, India
Forest Investigative Site
Manipal, Karna, India
Forest Investigative Site
Mysore, Karna, India
Forest Investigative Site
Pune, Mahara, India
Forest Investigative Site
Jaipur, Rajasthan, India
Forest Investigative Site
Chennai, Tamil Nadu, India
Forest Investigative Site
Chennai, Tamil Nadu, India
Forest Investigative Site
Tirupati, Tamil Nadu, India
Forest Investigative Site
Kanpur, Uttar Prad, India
Forest Investigative Site
Johor Bahru, , Malaysia
Forest Investigative Site
Kuala Lumpur, , Malaysia
Forest Investigative Site
Perak, , Malaysia
Forest Investigative Site
Arkhangelsk, , Russia
Forest Investigative Site
Gatchina, , Russia
Forest Investigative Site
Ivanovo, , Russia
Forest Investigative Site
Kazan', , Russia
Forest Investigative Site
Krasnodar, , Russia
Forest Investigative Site 204
Moscow, , Russia
Forest Investigative Site 206
Moscow, , Russia
Forest Investigative Site
Moscow, , Russia
Forest Investigative Site
Nizhny Novgorod, , Russia
Forest Investigative Site 214
Saint Petersburg, , Russia
Forest Investigative Site 217
Saint Petersburg, , Russia
Forest Investigative Site
Saint Petersburg, , Russia
Forest Investigative Site
Saint Petersburg, , Russia
Forest Investigative Site 202
Saint Petersburg, , Russia
Forest Investigative Site 203
Saint Petersburg, , Russia
Forest Investigative Site
Saint Petersburg, , Russia
Forest Investigative Site
Saint Petersburg, , Russia
Forest Investigative Site
Samara, , Russia
Forest Investigative Site
Kherson, Vil. Stepanivka, Ukraine
Forest Investigative Site
Chernihiv, , Ukraine
Forest Investigative Site
Dnipropetrovsk, , Ukraine
Forest Investigative Site
Donetsk, , Ukraine
Forest Investigative Site
Hlevakha, , Ukraine
Forest Investivative Site
Kharkiv, , Ukraine
Forest Investigative Site
Kiev, , Ukraine
Forest Investigative Site
Kyiv, , Ukraine
Forest Investigative Site
Kyiv, , Ukraine
Forest Investigative Site
Odesa, , Ukraine
Forest Investigative Site
Ternopil, , Ukraine
Countries
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References
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Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.
Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.
Other Identifiers
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RGH-MD-17
Identifier Type: -
Identifier Source: org_study_id
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