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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Cariprazine
Risperidone
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
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  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
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  • Forest Investigative Site
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  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 1
  • Forest Investigative Site 2
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 2
  • Forest Investigative Site1
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Placebo

Cariprazine 1.5 mg

Cariprazine 3.0 mg

Cariprazine 4.5 mg

Risperidone 4.0 mg

Arm Description

Participants received placebo orally once a day for 6 weeks.

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline to Week 6 in the CGI-S Score
The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.

Full Information

First Posted
June 6, 2008
Last Updated
May 17, 2019
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00694707
Brief Title
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Official Title
Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2008 (Actual)
Primary Completion Date
August 31, 2009 (Actual)
Study Completion Date
August 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo orally once a day for 6 weeks.
Arm Title
Cariprazine 1.5 mg
Arm Type
Experimental
Arm Description
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
Arm Title
Cariprazine 3.0 mg
Arm Type
Experimental
Arm Description
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
Arm Title
Cariprazine 4.5 mg
Arm Type
Experimental
Arm Description
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
Arm Title
Risperidone 4.0 mg
Arm Type
Active Comparator
Arm Description
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied in capsules.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
RGH-188
Intervention Description
Cariprazine was supplied in capsules
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Risperidone was supplied in capsules
Primary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the PANSS Total Score
Description
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.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the CGI-S Score
Description
The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values. First episode of psychosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suresh Durgam, MD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Forest Investigative Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Forest Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Forest Investigative Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Forest Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Forest Investigative Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Forest Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
28117
Country
United States
Facility Name
Forest Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Forest Investigative Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Forest Investigative Site
City
Vijaywada
State/Province
Andh Prad
ZIP/Postal Code
520002
Country
India
Facility Name
Forest Investigative Site
City
Visakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530017
Country
India
Facility Name
Forest Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Forest Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Forest Investigative Site
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Forest Investigative Site
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560027
Country
India
Facility Name
Forest Investigative Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
574160
Country
India
Facility Name
Forest Investigative Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Forest Investigative Site
City
Manipal
State/Province
Karna
ZIP/Postal Code
576104
Country
India
Facility Name
Forest Investigative Site
City
Mysore
State/Province
Karna
ZIP/Postal Code
570004
Country
India
Facility Name
Forest Investigative Site
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
Facility Name
Forest Investigative Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Forest Investigative Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Forest Investigative Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600101
Country
India
Facility Name
Forest Investigative Site
City
Tirupati
State/Province
Tamilnadu
ZIP/Postal Code
517507
Country
India
Facility Name
Forest Investigative Site
City
Kanpur
State/Province
Uttar Prad
ZIP/Postal Code
208005
Country
India
Facility Name
Forest Investigative Site
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Forest Investigative Site
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Forest Investigative Site
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Forest Investigative Site
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Forest Investigative Site
City
Ulu Kinta
State/Province
Perak
ZIP/Postal Code
31250
Country
Malaysia
Facility Name
Forest Investigative Site
City
Arkhangelsk
ZIP/Postal Code
163060
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Gatchina
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Forest Investigative Site 1
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site 2
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Forest Investigative Site
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Forest Investigative Site
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Forest Investigative Site
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Forest Investigative Site 2
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
Forest Investigative Site1
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
Facility Name
Forest Investigative Site
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Forest Investigative Site
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Forest Investigative Site
City
Dnipropetrovsk
State/Province
Dnipropetrovsk Oblast
ZIP/Postal Code
49616
Country
Ukraine
Facility Name
Forest Investigative Site
City
Donetsk
State/Province
Donetsk Oblast
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Forest Investigative Site
City
Kharkiv
State/Province
Kharkiv Oblast
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site
City
Glevakha
State/Province
Kyiv Oblast
ZIP/Postal Code
08630
Country
Ukraine
Facility Name
Forest Investigative Site
City
Kyiv
State/Province
Kyiv Oblast
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site
City
Kyiv
State/Province
Kyiv Oblast
ZIP/Postal Code
04655
Country
Ukraine
Facility Name
Forest Investigative Site
City
Odessa
State/Province
Odessa Oblast
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Forest Investigative Site
City
Ternopil
State/Province
Ternopil Oblast
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
Forest Investigative Site
City
Chernigiv
ZIP/Postal Code
14000
Country
Ukraine
Facility Name
Forest Investigative Site
City
Kherson, Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site
City
Kiev
ZIP/Postal Code
02660
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34091867
Citation
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.
Results Reference
derived
PubMed Identifier
33854317
Citation
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. Erratum In: Neuropsychiatr Dis Treat. 2021 May 17;17:1481.
Results Reference
derived
PubMed Identifier
30470662
Citation
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.
Results Reference
derived
PubMed Identifier
28692485
Citation
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.
Results Reference
derived
PubMed Identifier
26845266
Citation
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.
Results Reference
derived
PubMed Identifier
24412468
Citation
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.
Results Reference
derived

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

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