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Long-term Study of Cariprazine in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
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 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).

Exclusion Criteria:

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

Sites / Locations

  • Forest Investigative Site 072
  • Forest Investigative Site 021
  • Forest Investigative Site 086
  • Forest Investigative Site 014
  • Forest Investigative Site 080
  • Forest Investigative Site 079
  • Forest Investigative Site 048
  • Forest Investigative Site 070
  • Forest Investigative Site 022
  • Forest Investigative Site 083
  • Forest Investigative Site 050
  • Forest Investigative Site 006
  • Forest Investigative Site 003
  • Forest Investigative Site 016
  • Forest Investigative Site 073
  • Forest Investigative Site 071
  • Forest Investigative Site 002
  • Forest Investigative Site 041
  • Forest Investigative Site 082
  • Forest Investigative Site 055
  • Forest Investigative Site 087
  • Forest Investigative Site 012
  • Forest Investigative Site 018
  • Forest Investigative Site 008
  • Forest Investigative Site 044
  • Forest Investigative Site 007
  • Forest Investigative Site 017
  • Forest Investigative Site 076
  • Forest Investigative Site 045
  • Forest Investigative Site 052
  • Forest Investigative Site 004
  • Forest Investigative Site 040
  • Forest Investigative Site 019
  • Forest Investigative Site 077
  • Forest Investigative Site 047
  • Forest Investigative Site 074
  • Forest Investigative Site 084
  • Forest Investigative Site 043
  • Forest Investigative Site 078
  • Forest Investigative Site 601
  • Forest Investigative Site 604
  • Forest Investigative Site 602
  • Forest Investigative Site 605
  • Forest Investigative Site 503
  • Forest Investigative Site 519
  • Forest Investigative Site 501
  • Forest Investigative Site 500
  • Forest Investigative Site 507
  • Forest Investigative Site 518
  • Forest Investigative Site 517
  • Forest Investigative Site 515
  • Forest Investigative Site 510
  • Forest Investigative Site 513
  • Forest Investigative Site 509
  • Forest Investigative Site 506
  • Forest Investigative Site 505
  • Forest Investigative Site 306
  • Forest Investigative Site 301
  • Forest Investigative Site 300
  • Forest Investigative Site 311
  • Forest Investigative Site 303
  • Forest Investigative Site 304
  • Forest Investigative Site 102
  • Forest Investigative Site 103
  • Forest Investigative Site 104
  • Forest Investigative Site 110
  • Forest Investigative Site 108
  • Forest Investigative Site 112
  • Forest Investigative Site 105
  • Forest Investigative Site 106
  • Forest Investigative Site 113
  • Forest Investigative Site 107
  • Forest Investigative Site 109
  • Forest Investigative Site 100
  • Forest Investigative Site 211
  • Forest Investigative Site 206
  • Forest Investigative Site 208
  • Forest Investigative Site 205
  • Forest Investigative Site 200
  • Forest Investigative Site 204
  • Forest Investigative Site 203
  • Forest Investigative Site 201
  • Forest Investigative Site 202
  • Forest Investigative Site 209
  • Forest Investigative Site 210
  • Forest Investigative Site 207

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cariprazine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline to Week 48 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
April 12, 2010
Last Updated
July 25, 2019
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01104792
Brief Title
Long-term Study of Cariprazine in Patients With Schizophrenia
Official Title
Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2010 (Actual)
Primary Completion Date
January 31, 2013 (Actual)
Study Completion Date
January 31, 2013 (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 long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine
Arm Type
Experimental
Arm Description
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
RGH-188
Intervention Description
Cariprazine was supplied in capsules.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 48 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 48
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 48 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 48

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 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). Exclusion Criteria: Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
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 072
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Forest Investigative Site 021
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 086
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 014
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Forest Investigative Site 080
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
Forest Investigative Site 079
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 048
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 070
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 022
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 083
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 050
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site 006
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 003
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site 016
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Forest Investigative Site 073
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 071
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Forest Investigative Site 002
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Forest Investigative Site 041
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 082
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
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 087
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 012
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Forest Investigative Site 018
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site 008
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 044
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 007
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site 017
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 076
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Forest Investigative Site 045
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Forest Investigative Site 052
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Forest Investigative Site 004
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 040
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 019
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Forest Investigative Site 077
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Forest Investigative Site 047
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 074
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Forest Investigative Site 084
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Forest Investigative Site 043
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Forest Investigative Site 078
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
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 503
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 519
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 501
City
Ahmedabad
ZIP/Postal Code
380013
Country
India
Facility Name
Forest Investigative Site 500
City
Aurangabad
ZIP/Postal Code
431005
Country
India
Facility Name
Forest Investigative Site 507
City
Kanpur
ZIP/Postal Code
208005
Country
India
Facility Name
Forest Investigative Site 518
City
Lucknow
ZIP/Postal Code
226006
Country
India
Facility Name
Forest Investigative Site 517
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
Forest Investigative Site 515
City
Mangalore
ZIP/Postal Code
575018
Country
India
Facility Name
Forest Investigative Site 510
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Forest Investigative Site 513
City
Nashik
ZIP/Postal Code
422101
Country
India
Facility Name
Forest Investigative Site 509
City
Rajkot
ZIP/Postal Code
360002
Country
India
Facility Name
Forest Investigative Site 506
City
Varanasi
ZIP/Postal Code
201010
Country
India
Facility Name
Forest Investigative Site 505
City
Vijaywada
ZIP/Postal Code
520002
Country
India
Facility Name
Forest Investigative Site 306
City
Bucuresti
ZIP/Postal Code
41914
Country
Romania
Facility Name
Forest Investigative Site 301
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Forest Investigative Site 300
City
Craiova
ZIP/Postal Code
200620
Country
Romania
Facility Name
Forest Investigative Site 311
City
Craiova
ZIP/Postal Code
200745
Country
Romania
Facility Name
Forest Investigative Site 303
City
Targoviste
ZIP/Postal Code
130086
Country
Romania
Facility Name
Forest Investigative Site 304
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Forest Investigative Site 102
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
Forest Investigative Site 103
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Forest Investigative Site 104
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
Forest Investigative Site 110
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Forest Investigative Site 108
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Forest Investigative Site 112
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Forest Investigative Site 105
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Forest Investigative Site 106
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Forest Investigative Site 113
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Forest Investigative Site 107
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Forest Investigative Site 109
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Forest Investigative Site 100
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Forest Investigative Site 211
City
Glevakha
State/Province
Kyiv Region
ZIP/Postal Code
08631
Country
Ukraine
Facility Name
Forest Investigative Site 206
City
Kherson
State/Province
Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 208
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Forest Investigative Site 205
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Forest Investigative Site 200
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Forest Investigative Site 204
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 203
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 201
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 202
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Forest Investigative Site 209
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
Facility Name
Forest Investigative Site 210
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Forest Investigative Site 207
City
Vinnytsya
ZIP/Postal Code
21005
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
28836957
Citation
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.
Results Reference
derived

Learn more about this trial

Long-term Study of Cariprazine in Patients With Schizophrenia

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