Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

NCT00694707 | Completed Phase 2 Results

• 1 other identifier: RGH-MD-16
• Study Type: interventional
• Target: 732
• Locations: 5 countries
• Sites: 65

Brief Summary

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 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 6

Secondary Outcomes (1)

• Change From Baseline to Week 6 in the CGI-S Score

  Baseline to Week 6

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once a day for 6 weeks.

Drug: Placebo

Cariprazine 1.5 mg

EXPERIMENTAL

Participants received cariprazine 1.5 mg orally once a day for 6 weeks.

Drug: Cariprazine

Cariprazine 3.0 mg

EXPERIMENTAL

Participants received cariprazine 3.0 mg orally once a day for 6 weeks.

Drug: Cariprazine

Cariprazine 4.5 mg

EXPERIMENTAL

Participants received cariprazine 4.5 mg orally once a day for 6 weeks.

Drug: Cariprazine

Risperidone 4.0 mg

ACTIVE COMPARATOR

Participants received risperidone 4.0 mg orally once a day for 6 weeks.

Drug: Risperidone

Interventions

Placebo DRUG

Placebo was supplied in capsules.

Placebo

Cariprazine DRUG

Cariprazine was supplied in capsules

Also known as: RGH-188

Cariprazine 1.5 mg; Cariprazine 3.0 mg; Cariprazine 4.5 mg

Risperidone DRUG

Risperidone was supplied in capsules

Also known as: Risperdal

Risperidone 4.0 mg

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 to 60 years of age.
• Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
• Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
• Diagnosis of schizophrenia for at least 1 year.

You may not qualify if:

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
• First episode of psychosis.

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

Location

Forest Investigative Site

Paramount, California, 90723, United States

Location

Forest Investigative Site

Riverside, California, 92506, United States

Location

Forest Investigative Site

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

Location

Forest Investigative Site

Bradenton, Florida, 34208, United States

Location

Forest Investigative Site

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site

Lake Charles, Louisiana, 70601, United States

Location

Forest Investigative Site

Baltimore, Maryland, 21202, United States

Location

Forest Investigative Site

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site

Bridgeton, Missouri, 63044, United States

Location

Forest Investigative Site

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site

Charleston, South Carolina, 29405, United States

Location

Forest Investigative Site

Memphis, Tennessee, 28117, United States

Location

Forest Investigative Site

Houston, Texas, 77008, United States

Location

Forest Investigative Site

Houston, Texas, 77021, United States

Location

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

Location

Forest Investigative Site

Ahmedabad, Gujarat, 380015, India

Location

Forest Investigative Site

Bangalore, Karna, 560010, India

Location

Forest Investigative Site

Bangalore, Karna, 560027, India

Location

Forest Investigative Site

Mangalore, Karna, 574160, India

Location

Forest Investigative Site

Mangalore, Karna, 575001, India

Location

Forest Investigative Site

Manipal, Karna, 576104, India

Location

Forest Investigative Site

Mysore, Karna, 570004, India

Location

Forest Investigative Site

Pune, Mahara, 411004, India

Location

Forest Investigative Site

Jaipur, Rajasthan, 302021, India

Location

Forest Investigative Site

Chennai, Tamil Nadu, 600003, India

Location

Forest Investigative Site

Chennai, Tamil Nadu, 600101, India

Location

Forest Investigative Site

Tirupati, Tamil Nadu, 517507, India

Location

Forest Investigative Site

Kanpur, Uttar Prad, 208005, India

Location

Forest Investigative Site

Johor Bahru, Johor, 80100, Malaysia

Location

Forest Investigative Site

Kota Bharu, Kelantan, 15586, Malaysia

Location

Forest Investigative Site

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Forest Investigative Site

Ipoh, Perak, 30990, Malaysia

Location

Forest Investigative Site

Ulu Kinta, Perak, 31250, Malaysia

Location

Forest Investigative Site

Arkhangelsk, 163060, Russia

Location

Forest Investigative Site

Gatchina, 188357, Russia

Location

Forest Investigative Site

Kazan', 420012, Russia

Location

Forest Investigative Site 1

Moscow, 115522, Russia

Location

Forest Investigative Site 2

Moscow, 115522, Russia

Location

Forest Investigative Site

Moscow, 117152, Russia

Location

Forest Investigative Site

Nizhny Novgorod, 603155, Russia

Location

Forest Investigative Site

Saint Petersburg, 190005, Russia

Location

Forest Investigative Site

Saint Petersburg, 190121, Russia

Location

Forest Investigative Site

Saint Petersburg, 191119, Russia

Location

Forest Investigative Site 2

Saint Petersburg, 193019, Russia

Location

Forest Investigative Site1

Saint Petersburg, 193019, Russia

Location

Forest Investigative Site

Saint Petersburg, 193167, Russia

Location

Forest Investigative Site

Saint Petersburg, 197341, Russia

Location

Forest Investigative Site

Samara, 443016, Russia

Location

Forest Investigative Site

Dnipropetrovsk, Dnipropetrovsk Oblast, 49616, Ukraine

Location

Forest Investigative Site

Donetsk, Donetsk Oblast, 83037, Ukraine

Location

Forest Investigative Site

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

Forest Investigative Site

Hlevakha, Kyiv Oblast, 08630, Ukraine

Location

Forest Investigative Site

Kyiv, Kyiv Oblast, 04080, Ukraine

Location

Forest Investigative Site

Kyiv, Kyiv Oblast, 04655, Ukraine

Location

Forest Investigative Site

Odesa, Odesa Oblast, 65006, Ukraine

Location

Forest Investigative Site

Ternopil, Ternopil Oblast, 46020, Ukraine

Location

Forest Investigative Site

Chernihiv, 14000, Ukraine

Location

Forest Investigative Site

Kherson, Vil. Stepanivka, 73488, Ukraine

Location

Forest Investigative Site

Kiev, 02660, Ukraine

Location

Related Publications (6)

• 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

• Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.

  PMID: 30470662 DERIVED

• Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.

  PMID: 28692485 DERIVED

• Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.

  PMID: 26845266 DERIVED

• Durgam S, Starace A, Li D, Migliore R, Ruth A, Nemeth G, Laszlovszky I. An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: a phase II, randomized clinical trial. Schizophr Res. 2014 Feb;152(2-3):450-7. doi: 10.1016/j.schres.2013.11.041. Epub 2014 Jan 10.

  PMID: 24412468 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 Laboratories

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: June 30, 2008
• Primary Completion: August 31, 2009
• Study Completion: August 31, 2009
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Locations

IN (16); US (18); UA (11); RU (15); MY (5)