Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905307
• Other study ID #: 331-07-203
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: September 29, 2015
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria

2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia

3. Subjects experiencing an acute exacerbation of psychotic symptoms

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

2. 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

3. Subjects presenting with a first episode of schizophrenia

4. Other protocol specific inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• OPC-34712
oral, once daily
• Placebo
Placebo
• Aripiprazole
oral, once daily

Locations

Country	Name	City	State
Bulgaria	Study Site	Burgas
Bulgaria	Study Site	Kazanlak
Bulgaria	Study Site	Pazardzhik
Bulgaria	Study Site	Plovdiv
Bulgaria	Study Site	Radnevo
Bulgaria	Study Site	Ruse
Croatia	Study Site	Rijeka
Croatia	Study Site	Split
Croatia	Study Site	Zagreb
India	Study Site	Ahmedabad	Gujarat
India	Study Site	Bangalore	Karna
India	Study Site	Chennai	Tamilnadu
India	Study Site	Mangalore	Karna
India	Study Site	Mangalore	Karna
India	Study Site	Pune	Mahara
India	Study Site	Varanasi	Uttar Prad
India	Study Site	Vijaywada	Andh Prad
India	Study Site	Visakhapatnam	Andh Prad
Korea, Republic of	Study Site	Busan
Korea, Republic of	Study Site	Chuncheon
Korea, Republic of	Study Site	Incheon
Korea, Republic of	Study Site	Incheon
Korea, Republic of	Study Site	Seoul
Philippines	Study Site	Cebu City 6000
Philippines	Study Site	Mandaluyong City 1553
Romania	Study Site	Arad
Romania	Study Site	Bucuresti
Romania	Study Site (1)	Bucuresti
Romania	Study Site (2)	Bucuresti
Romania	Study Site (3)	Bucuresti
Romania	Study Site	Cluj-Napoca
Romania	Study Site	Oradea
Russian Federation	Study Site	Moscow
Russian Federation	Study Site	Moscow
Russian Federation	Study Site	Moscow Region
Russian Federation	Study Site	St. Petersburg
Russian Federation	Study Site	St. Petersburg
Russian Federation	Study Site	St. Petersburg
Serbia	Study Site (1)	Belgrade
Serbia	Study Site (2)	Belgrade
Serbia	Study Site	Kragujevac
Serbia	Study Site	Novi Sad
Slovakia	Study Site	Bojnice
Slovakia	Study Site	Bratislava
Slovakia	Study Site	Liptovsky Mikulas
Slovakia	Study Site	Rimavska Sobota
Slovakia	Study Site	Zilina
Taiwan	Study Site	Hualien Town
Taiwan	Study Site	Taipei
Ukraine	Study Site	Chernigiv
Ukraine	Study Site	Dnipropetrovsk
Ukraine	Study Site	Kherson,Vil. Stepanivka
Ukraine	Study Site	Kyiv
Ukraine	Study Site	Kyiv
Ukraine	Study Site	Kyiv
Ukraine	Study Site	Simferopol
Ukraine	Study Site	Vinnitsia
United States	Study Site	Austin	Texas
United States	Study Site	Bradenton	Florida
United States	Study Site	Cedarhurst	New York
United States	Study Site	Escondido	California
United States	Study Site	Garden Grove	California
United States	Study Site	Little Rock	Arkansas
United States	Study Site	Long Beach	California
United States	Study Site	Maitland	Florida
United States	Study Site	Oceanside	California
United States	Study Site	Pasadena	California
United States	Study Site	Philadelphia	Pennsylvania
United States	Study Site	San Diego	California
United States	Study Site	San Diego	California
United States	Study Site	Santa Ana	California
United States	Study Site	St. Louis	Missouri
United States	Study Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  India,  Korea, Republic of,  Philippines,  Romania,  Russian Federation,  Serbia,  Slovakia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 6	No
Secondary	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.	Baseline to Week 6	No
Secondary	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.	Baseline to Week 6	No
Secondary	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.	Baseline to Week 6	No
Secondary	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	Baseline to Week 6	No
Secondary	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.	Week 6	No
Secondary	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	Week 6	No
Secondary	Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712	Efficacy-related discontinuation rate was assessed	Baseline to Week 6	No