Back to resultsStudy to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia (STEP 203)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OPC-34712
Placebo
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Relapsed
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- Subjects experiencing an acute exacerbation of psychotic symptoms
Exclusion Criteria:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
Subjects with a current DSM-IV-TR Axis I diagnosis of:
- Schizoaffective disorder
- MDD
- Bipolar disorder
- Delirium, dementia, amnestic or other cognitive disorder
- Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
- Subjects presenting with a first episode of schizophrenia
- Other protocol specific inclusion/exclusion criteria may apply
Sites / Locations
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- Study Site (1)
- Study Site (2)
- Study Site (3)
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- Study Site (1)
- Study Site (2)
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
4
5
6
Arm Description
OPC-34712 0.25 mg arm
OPC-34712 low-dose arm
OPC-34712 mid-dose arm
OPC-34712 high-dose arm
Aripiprazole arm
Outcomes
Primary Outcome Measures
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Secondary Outcome Measures
Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.
Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.
Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.
Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients
Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Response Rate at Week 6
Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6
Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
Efficacy-related discontinuation rate was assessed
Full Information
NCT ID
NCT00905307
First Posted
May 19, 2009
Last Updated
September 29, 2015
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00905307
Brief Title
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Acronym
STEP 203
Official Title
A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
OPC-34712 0.25 mg arm
Arm Title
2
Arm Type
Experimental
Arm Description
OPC-34712 low-dose arm
Arm Title
3
Arm Type
Experimental
Arm Description
OPC-34712 mid-dose arm
Arm Title
4
Arm Type
Experimental
Arm Description
OPC-34712 high-dose arm
Arm Title
5
Arm Type
Placebo Comparator
Arm Title
6
Arm Type
Active Comparator
Arm Description
Aripiprazole arm
Intervention Type
Drug
Intervention Name(s)
OPC-34712
Intervention Description
oral, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
oral, once daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
Description
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
Description
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame
Baseline to Week 6
Title
Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
Description
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.
Time Frame
Baseline to Week 6
Title
Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
Description
The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.
Time Frame
Baseline to Week 6
Title
Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
Description
The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients
Time Frame
Baseline to Week 6
Title
Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
Description
The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame
Week 6
Title
Response Rate at Week 6
Description
Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6
Time Frame
Week 6
Title
Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
Description
Efficacy-related discontinuation rate was assessed
Time Frame
Baseline to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
Subjects experiencing an acute exacerbation of psychotic symptoms
Exclusion Criteria:
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
Subjects with a current DSM-IV-TR Axis I diagnosis of:
Schizoaffective disorder
MDD
Bipolar disorder
Delirium, dementia, amnestic or other cognitive disorder
Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
Subjects presenting with a first episode of schizophrenia
Other protocol specific inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Study Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Study Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Study Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92645
Country
United States
Facility Name
Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Study Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Study Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Study Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Study Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Study Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Study Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Study Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Study Site
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Study Site
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Study Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Study Site
City
Radnevo
ZIP/Postal Code
6260
Country
Bulgaria
Facility Name
Study Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Study Site
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Study Site
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Study Site
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
Study Site
City
Vijaywada
State/Province
Andh Prad
ZIP/Postal Code
520002
Country
India
Facility Name
Study Site
City
Visakhapatnam
State/Province
Andh Prad
ZIP/Postal Code
530017
Country
India
Facility Name
Study Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Study Site
City
Bangalore
State/Province
Karna
ZIP/Postal Code
560010
Country
India
Facility Name
Study Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Study Site
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575018
Country
India
Facility Name
Study Site
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
Facility Name
Study Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Study Site
City
Varanasi
State/Province
Uttar Prad
ZIP/Postal Code
221005
Country
India
Facility Name
Study Site
City
Busan
ZIP/Postal Code
613-735
Country
Korea, Republic of
Facility Name
Study Site
City
Chuncheon
ZIP/Postal Code
200-704
Country
Korea, Republic of
Facility Name
Study Site
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Study Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Study Site
City
Seoul
ZIP/Postal Code
143-711
Country
Korea, Republic of
Facility Name
Study Site
City
Cebu City 6000
Country
Philippines
Facility Name
Study Site
City
Mandaluyong City 1553
Country
Philippines
Facility Name
Study Site
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Study Site
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Study Site (1)
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Study Site (2)
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Study Site (3)
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Study Site
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Study Site
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Study Site
City
Moscow Region
ZIP/Postal Code
141371
Country
Russian Federation
Facility Name
Study Site
City
Moscow
ZIP/Postal Code
113152
Country
Russian Federation
Facility Name
Study Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Study Site
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Study Site
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Study Site
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Study Site (1)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Study Site (2)
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Study Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Study Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Study Site
City
Bojnice
ZIP/Postal Code
92701
Country
Slovakia
Facility Name
Study Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Study Site
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
Study Site
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
Facility Name
Study Site
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Study Site
City
Hualien Town
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Study Site
City
Taipei
ZIP/Postal Code
249
Country
Taiwan
Facility Name
Study Site
City
Chernigiv
ZIP/Postal Code
14005
Country
Ukraine
Facility Name
Study Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Study Site
City
Kherson,Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Study Site
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Study Site
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Study Site
City
Kyiv
ZIP/Postal Code
04655
Country
Ukraine
Facility Name
Study Site
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Study Site
City
Vinnitsia
ZIP/Postal Code
21018
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
27188270
Citation
Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.
Results Reference
derived
PubMed Identifier
26250067
Citation
Citrome L. Brexpiprazole for schizophrenia and as adjunct for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antipsychotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int J Clin Pract. 2015 Sep;69(9):978-97. doi: 10.1111/ijcp.12714. Epub 2015 Aug 6.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
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