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Safety and Efficacy of Cariprazine in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who have provided informed consent 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)
  • Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
  • Patients in their first episode of psychosis
  • Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
  • Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
  • Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
  • Substance abuse or dependence within the prior 3 months

Sites / Locations

  • Forest Investigative Site 48
  • Forest Investigative Site 50
  • Forest Investigative Site 42
  • Forest Investigative Site 054
  • Forest Investigative Site 41
  • Forest Investigative Site 055
  • Forest Investigative Site 44
  • Forest Investigative Site 45
  • Forest Investigative Site 52
  • Forest Investigative Site 40
  • Forest Investigative Site 46
  • Forest Investigative Site 47
  • Forest Investigative 49
  • Forest Investigative Site 51
  • Forest Investigative Site 43
  • Forest Investigative Site 601
  • Forest Investigative Site 604
  • Forest Investigative Site 602
  • Forest Investigative Site 605
  • Forest Investigative Site 505
  • Forest Investigative Site 514
  • Forest Investigative Site 503
  • Forest Investigative Site 519
  • Forest Investigative Site 501
  • Forest Investigative Site 508
  • Forest Investigative Site 504
  • Forest Investigative Site 517
  • Forest Investigative Site 515
  • Forest Investigative Site 516
  • Forest Investigative Site 500
  • Forest Investigative Site 510
  • Forest Investigative Site 513
  • Forest Investigative Site 511
  • Forest Investigative Site 502
  • Forest Investigative Site 509
  • Forest Investigative Site 507
  • Forest Investigative Site 518
  • Forest Investigative Site 506
  • Forest Investigative Site 704
  • Forest Investigative Site 703
  • Forest Investigative Site 706

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cariprazine (3-6 mg/day)

Cariprazine (6-9 mg/day)

Placebo

Arm Description

Cariprazine once daily fixed-flexible low dose

Cariprazine once daily fixed-flexible high dose

Placebo

Outcomes

Primary Outcome Measures

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.

Secondary Outcome Measures

Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.

Full Information

First Posted
April 14, 2010
Last Updated
October 18, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01104779
Brief Title
Safety and Efficacy of Cariprazine in Schizophrenia
Official Title
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2010 (Actual)
Primary Completion Date
December 15, 2011 (Actual)
Study Completion Date
December 15, 2011 (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
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine (3-6 mg/day)
Arm Type
Experimental
Arm Description
Cariprazine once daily fixed-flexible low dose
Arm Title
Cariprazine (6-9 mg/day)
Arm Type
Experimental
Arm Description
Cariprazine once daily fixed-flexible high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
RGH-188
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Primary Outcome Measure Information:
Title
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Description
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater 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: Patients who have provided informed consent 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) Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120 Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) Exclusion Criteria: Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder Patients in their first episode of psychosis Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study Substance abuse or dependence within the prior 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Migliore, MA
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 48
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 50
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site 42
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Forest Investigative Site 054
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Forest Investigative Site 41
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 055
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 44
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 45
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Forest Investigative Site 52
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Forest Investigative Site 40
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 46
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 47
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative 49
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 51
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Forest Investigative Site 43
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Forest Investigative Site 601
City
Bello
State/Province
Antioquia
ZIP/Postal Code
051053
Country
Colombia
Facility Name
Forest Investigative Site 604
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660003
Country
Colombia
Facility Name
Forest Investigative Site 602
City
Bogota
ZIP/Postal Code
110121
Country
Colombia
Facility Name
Forest Investigative Site 605
City
Bogota
ZIP/Postal Code
111166
Country
Colombia
Facility Name
Forest Investigative Site 505
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Forest Investigative Site 514
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Facility Name
Forest Investigative Site 503
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 519
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 501
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Forest Investigative Site 508
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Forest Investigative Site 504
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Forest Investigative Site 517
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Forest Investigative Site 515
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575018
Country
India
Facility Name
Forest Investigative Site 516
City
Mysore
State/Province
Karna
ZIP/Postal Code
570015
Country
India
Facility Name
Forest Investigative Site 500
City
Aurangabad
State/Province
Mahara
ZIP/Postal Code
431005
Country
India
Facility Name
Forest Investigative Site 510
City
Mumbai
State/Province
Mahara
ZIP/Postal Code
400026
Country
India
Facility Name
Forest Investigative Site 513
City
Nashik
State/Province
Mahara
ZIP/Postal Code
422101
Country
India
Facility Name
Forest Investigative Site 511
City
Pune
State/Province
Mahara
ZIP/Postal Code
411001
Country
India
Facility Name
Forest Investigative Site 502
City
Pune
State/Province
Mahara
ZIP/Postal Code
411030
Country
India
Facility Name
Forest Investigative Site 509
City
Rajkot
State/Province
Rajastan
ZIP/Postal Code
360002
Country
India
Facility Name
Forest Investigative Site 507
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208005
Country
India
Facility Name
Forest Investigative Site 518
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226006
Country
India
Facility Name
Forest Investigative Site 506
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
201010
Country
India
Facility Name
Forest Investigative Site 704
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Forest Investigative Site 703
City
Cape Town
State/Province
W Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Forest Investigative Site 706
City
Cape Town
State/Province
W Cape
ZIP/Postal Code
7535
Country
South Africa

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
28478771
Citation
Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.
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

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Safety and Efficacy of Cariprazine in Schizophrenia

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