Long-term Study of Cariprazine in Patients With Schizophrenia

NCT01104792 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-11
• Study Type: interventional
• Target: 752
• Locations: 6 countries
• Sites: 86

Brief Summary

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Acute schizophrenia; Psychotropic drugs; Antipsychotic agents; Mental disorders; Dopamine agents; Central nervous system agents

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 48 in the PANSS Total Score

  The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.

  Baseline to Week 48

Secondary Outcomes (1)

• Change From Baseline to Week 48 in the CGI-S Score

  Baseline to Week 48

Study Arms (1)

Cariprazine

EXPERIMENTAL

Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.

Drug: Cariprazine

Interventions

Cariprazine DRUG

Cariprazine was supplied in capsules.

Also known as: RGH-188

Cariprazine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.
• Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
• Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

You may not qualify if:

• Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (86)

Forest Investigative Site 072

Little Rock, Arkansas, 72201, United States

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Forest Investigative Site 021

Little Rock, Arkansas, 72211, United States

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Forest Investigative Site 086

Little Rock, Arkansas, 72211, United States

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Forest Investigative Site 014

Springdale, Arkansas, 72764, United States

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Forest Investigative Site 080

Carson, California, 90746, United States

Location

Forest Investigative Site 079

Cerritos, California, 90703, United States

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Forest Investigative Site 048

Costa Mesa, California, 92626, United States

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Forest Investigative Site 070

Costa Mesa, California, 92626, United States

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Forest Investigative Site 022

Garden Grove, California, 92845, United States

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Forest Investigative Site 083

Garden Grove, California, 92845, United States

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Forest Investigative Site 050

Long Beach, California, 90813, United States

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Forest Investigative Site 006

Oceanside, California, 92056, United States

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Forest Investigative Site 003

Riverside, California, 92506, United States

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Forest Investigative Site 016

San Diego, California, 92123, United States

Location

Forest Investigative Site 073

Santa Ana, California, 92701, United States

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Forest Investigative Site 071

New Britain, Connecticut, 06050, United States

Location

Forest Investigative Site 002

Bradenton, Florida, 34208, United States

Location

Forest Investigative Site 041

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 082

North Miami, Florida, 33161, United States

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Forest Investigative Site 055

Atlanta, Georgia, 30308, United States

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Forest Investigative Site 087

Atlanta, Georgia, 30308, United States

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Forest Investigative Site 012

Honolulu, Hawaii, 96813, United States

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Forest Investigative Site 018

Chicago, Illinois, 60640, United States

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Forest Investigative Site 008

Hoffman Estates, Illinois, 60169, United States

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Forest Investigative Site 044

Rockville, Maryland, 20850, United States

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Forest Investigative Site 007

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site 017

Creve Coeur, Missouri, 63141, United States

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Forest Investigative Site 076

Saint Charles, Missouri, 63301, United States

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Forest Investigative Site 045

St Louis, Missouri, 63118, United States

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Forest Investigative Site 052

Las Vegas, Nevada, 89102, United States

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Forest Investigative Site 004

Willingboro, New Jersey, 08046, United States

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Forest Investigative Site 040

Cedarhurst, New York, 11516, United States

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Forest Investigative Site 019

Willoughby, Ohio, 44094, United States

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Forest Investigative Site 077

Philadelphia, Pennsylvania, 19131, United States

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Forest Investigative Site 047

Philadelphia, Pennsylvania, 19139, United States

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Forest Investigative Site 074

Austin, Texas, 78756, United States

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Forest Investigative Site 084

DeSoto, Texas, 75115, United States

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Forest Investigative Site 043

Irving, Texas, 75062, United States

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Forest Investigative Site 078

Bellevue, Washington, 98007, United States

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Forest Investigative Site 601

Bello, Antioquia, 051053, Colombia

Location

Forest Investigative Site 604

Pereira, Risaralda Department, 660003, Colombia

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Forest Investigative Site 602

Bogotá, 110121, Colombia

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Forest Investigative Site 605

Bogotá, 111166, Colombia

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Forest Investigative Site 503

Ahmedabad, 380006, India

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Forest Investigative Site 519

Ahmedabad, 380006, India

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Forest Investigative Site 501

Ahmedabad, 380013, India

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Forest Investigative Site 500

Aurangabad, 431005, India

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Forest Investigative Site 507

Kanpur, 208005, India

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Forest Investigative Site 518

Lucknow, 226006, India

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Forest Investigative Site 517

Mangalore, 575001, India

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Forest Investigative Site 515

Mangalore, 575018, India

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Forest Investigative Site 510

Mumbai, 400026, India

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Forest Investigative Site 513

Nashik, 422101, India

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Forest Investigative Site 509

Rajkot, 360002, India

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Forest Investigative Site 506

Varanasi, 201010, India

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Forest Investigative Site 505

Vijaywada, 520002, India

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Forest Investigative Site 306

Bucharest, 41914, Romania

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Forest Investigative Site 301

Cluj-Napoca, 400012, Romania

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Forest Investigative Site 300

Craiova, 200620, Romania

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Forest Investigative Site 311

Craiova, 200745, Romania

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Forest Investigative Site 303

Târgovişte, 130086, Romania

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Forest Investigative Site 304

Târgu Mureş, 540142, Romania

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Forest Investigative Site 102

Arkhangelsk, 163530, Russia

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Forest Investigative Site 103

Chelyabinsk, 454087, Russia

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Forest Investigative Site 104

Chita, 672090, Russia

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Forest Investigative Site 112

Saint Petersburg, 190121, Russia

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Forest Investigative Site 105

Saint Petersburg, 192019, Russia

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Forest Investigative Site 106

Saint Petersburg, 192019, Russia

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Forest Investigative Site 113

Saint Petersburg, 192019, Russia

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Forest Investigative Site 107

Saint Petersburg, 193167, Russia

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Forest Investigative Site 109

Saint Petersburg, 197341, Russia

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Forest Investigative Site 110

Saratov, 410028, Russia

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Forest Investigative Site 108

Saratov, 410060, Russia

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Forest Investigative Site 100

Tomsk, 634014, Russia

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Forest Investigative Site 211

Hlevakha, Kyiv Oblast, 08631, Ukraine

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Forest Investigative Site 206

Kherson, Stepanivka, 73488, Ukraine

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Forest Investigative Site 208

Dnipropetrovsk, 49005, Ukraine

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Forest Investigative Site 205

Dnipropetrovsk, 49027, Ukraine

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Forest Investigative Site 200

Donetsk, 83008, Ukraine

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Forest Investigative Site 203

Kharkiv, 61068, Ukraine

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Forest Investigative Site 204

Kharkiv, 61068, Ukraine

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Forest Investigative Site 201

Kyiv, 04080, Ukraine

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Forest Investigative Site 202

Lviv, 79021, Ukraine

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Forest Investigative Site 209

Poltava, 36006, Ukraine

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Forest Investigative Site 210

Simferopol, 95006, Ukraine

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Forest Investigative Site 207

Vinnytsia, 21005, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 34091867 DERIVED

• 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.

  PMID: 33854317 DERIVED

• 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.

  PMID: 28836957 DERIVED

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Willie R. Earley, MD Associate Vice President Clinical Development-CNS
• Organization: Allergan

IR-CTRegistration@allergan.com,

714-246-4500

Study Officials

• Raffaele Migliore, MA

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: April 12, 2010
• First Posted: April 15, 2010
• Study Start: May 31, 2010
• Primary Completion: January 31, 2013
• Study Completion: January 31, 2013
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-07

Locations

RU (12); US (39); CO (4); IN (13); RO (6); UA (12)