A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

NCT00839852 | Completed Phase 2 Results

• 1 other identifier: RGH-MD-17
• Study Type: interventional
• Target: 97
• Locations: 5 countries
• Sites: 65

Brief Summary

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Conditions

Schizophrenia

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 1.5mg

EXPERIMENTAL

Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability

Drug: Cariprazine

Interventions

Cariprazine DRUG

Cariprazine was supplied in capsules.

Also known as: RGH-188

Cariprazine 1.5mg

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
• 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.

You may not qualify if:

• Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

Sponsors & Collaborators

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

Study Sites (65)

Forest Investigative Site

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site

Long Beach, California, 90813, United States

Location

Forest Investigative Site

Oceanside, California, 92056, United States

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Forest Investigative Site

Paramount, California, 90723, United States

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Forest Investigative Site

Riverside, California, 92506, United States

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Forest Investigative Site

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

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Forest Investigative Site

Bradenton, Florida, 34208, United States

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Forest Investigative Site

Kissimmee, Florida, 34741, United States

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Forest Investigative Site

Lake Charles, Louisiana, 70601, United States

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Forest Investigative Site

Baltimore, Maryland, 21202, United States

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Forest Investigative Site

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site

Creve Coeur, Missouri, 63141, United States

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Forest Investigative Site

Cincinnati, Ohio, 45267, United States

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Forest Investigative Site

Charleston, South Carolina, 29405, United States

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Forest Investigative Site

Memphis, Tennessee, 38119, United States

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Forest Investigative Site

Houston, Texas, 77008, United States

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Forest Investigative Site

Irving, Texas, 75062, United States

Location

Forest Investigative Site

Vijaywada, Andh Prad, 520002, India

Location

Forest Investigative Site

Visakhapatnam, Andh Prad, 530017, India

Location

Forest Investigative Site

Ahmedabad, Gujarat, 380013, India

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Forest Investigative Site

Ahmedabad, Gujarat, 380015, India

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Forest Investigative Site

Bangalore, Karna, 560010, India

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Forest Investigative Site

Bangalore, Karna, 560027, India

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Forest Investigative Site

Mangalore, Karna, 574160, India

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Forest Investigative Site

Mangalore, Karna, 575001, India

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Forest Investigative Site

Manipal, Karna, 576104, India

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Forest Investigative Site

Mysore, Karna, 570004, India

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Forest Investigative Site

Pune, Mahara, 411004, India

Location

Forest Investigative Site

Jaipur, Rajasthan, 302021, India

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Forest Investigative Site

Chennai, Tamil Nadu, 600003, India

Location

Forest Investigative Site

Chennai, Tamil Nadu, 600101, India

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Forest Investigative Site

Tirupati, Tamil Nadu, 517507, India

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Forest Investigative Site

Kanpur, Uttar Prad, 208005, India

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Forest Investigative Site

Johor Bahru, 80100, Malaysia

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Forest Investigative Site

Kuala Lumpur, 59100, Malaysia

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Forest Investigative Site

Perak, 30990, Malaysia

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Forest Investigative Site

Arkhangelsk, 163060, Russia

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Forest Investigative Site

Gatchina, 188357, Russia

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Forest Investigative Site

Ivanovo, 153462, Russia

Location

Forest Investigative Site

Kazan', 420012, Russia

Location

Forest Investigative Site

Krasnodar, 350007, Russia

Location

Forest Investigative Site 204

Moscow, 115522, Russia

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Forest Investigative Site 206

Moscow, 115522, Russia

Location

Forest Investigative Site

Moscow, 117152, Russia

Location

Forest Investigative Site

Nizhny Novgorod, 603155, Russia

Location

Forest Investigative Site 214

Saint Petersburg, 190005, Russia

Location

Forest Investigative Site 217

Saint Petersburg, 190005, Russia

Location

Forest Investigative Site

Saint Petersburg, 190121, Russia

Location

Forest Investigative Site

Saint Petersburg, 191119, Russia

Location

Forest Investigative Site 202

Saint Petersburg, 193019, Russia

Location

Forest Investigative Site 203

Saint Petersburg, 193019, Russia

Location

Forest Investigative Site

Saint Petersburg, 193167, Russia

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Forest Investigative Site

Saint Petersburg, 197341, Russia

Location

Forest Investigative Site

Samara, 443016, Russia

Location

Forest Investigative Site

Kherson, Vil. Stepanivka, 73488, Ukraine

Location

Forest Investigative Site

Chernihiv, 14000, Ukraine

Location

Forest Investigative Site

Dnipropetrovsk, 49616, Ukraine

Location

Forest Investigative Site

Donetsk, 83037, Ukraine

Location

Forest Investigative Site

Hlevakha, 8630, Ukraine

Location

Forest Investivative Site

Kharkiv, 61068, Ukraine

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Forest Investigative Site

Kiev, 2660, Ukraine

Location

Forest Investigative Site

Kyiv, 4080, Ukraine

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Forest Investigative Site

Kyiv, 4655, Ukraine

Location

Forest Investigative Site

Odesa, 65006, Ukraine

Location

Forest Investigative Site

Ternopil, 46020, 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

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental 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

• Suresh Durgam, MD

  Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 10, 2009
• Study Start: May 31, 2009
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Locations

US (17); UA (11); RU (18); MY (3); IN (16)