Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia (STEP 203)

September 29, 2015 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
459

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Study site
      • Kazanlak, Bulgaria, 6100
        • Study site
      • Pazardzhik, Bulgaria, 4400
        • Study site
      • Plovdiv, Bulgaria, 4002
        • Study site
      • Radnevo, Bulgaria, 6260
        • Study site
      • Ruse, Bulgaria, 7003
        • Study site
  • Croatia
      • Rijeka, Croatia, 51000
        • Study site
      • Split, Croatia, 21000
        • Study site
      • Zagreb, Croatia, 10090
        • Study site
  • India
    • Andh Prad
      • Vijaywada, Andh Prad, India, 520002
        • Study site
      • Visakhapatnam, Andh Prad, India, 530017
        • Study site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Study site
    • Karna
      • Bangalore, Karna, India, 560010
        • Study site
      • Mangalore, Karna, India, 575001
        • Study site
      • Mangalore, Karna, India, 575018
        • Study site
    • Mahara
      • Pune, Mahara, India, 411004
        • Study site
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600003
        • Study site
    • Uttar Prad
      • Varanasi, Uttar Prad, India, 221005
        • Study site
  • Korea, Republic of
      • Busan, Korea, Republic of, 613-735
        • Study site
      • Chuncheon, Korea, Republic of, 200-704
        • Study site
      • Incheon, Korea, Republic of, 400-711
        • Study site
      • Incheon, Korea, Republic of, 405-760
        • Study site
      • Seoul, Korea, Republic of, 143-711
        • Study site
  • Philippines
      • Cebu City 6000, Philippines
        • Study site
      • Mandaluyong City 1553, Philippines
        • Study site
  • Romania
      • Arad, Romania, 310022
        • Study site
      • Bucuresti, Romania, 010825
        • Study site
      • Bucuresti, Romania, 041914
        • Study Site (1)
      • Bucuresti, Romania, 041914
        • Study Site (2)
      • Bucuresti, Romania, 041914
        • Study Site (3)
      • Cluj-Napoca, Romania, 400012
        • Study site
      • Oradea, Romania, 410154
        • Study site
  • Russian Federation
      • Moscow, Russian Federation, 113152
        • Study site
      • Moscow, Russian Federation, 115522
        • Study site
      • Moscow Region, Russian Federation, 141371
        • Study site
      • St. Petersburg, Russian Federation, 190121
        • Study site
      • St. Petersburg, Russian Federation, 193167
        • Study site
      • St. Petersburg, Russian Federation, 197341
        • Study site
  • Serbia
      • Belgrade, Serbia, 11000
        • Study Site (1)
      • Belgrade, Serbia, 11000
        • Study Site (2)
      • Kragujevac, Serbia, 34000
        • Study site
      • Novi Sad, Serbia, 21000
        • Study site
  • Slovakia
      • Bojnice, Slovakia, 92701
        • Study site
      • Bratislava, Slovakia, 82606
        • Study site
      • Liptovsky Mikulas, Slovakia, 03123
        • Study site
      • Rimavska Sobota, Slovakia, 97912
        • Study site
      • Zilina, Slovakia, 01207
        • Study site
  • Taiwan
      • Hualien Town, Taiwan, 970
        • Study site
      • Taipei, Taiwan, 249
        • Study site
  • Ukraine
      • Chernigiv, Ukraine, 14005
        • Study site
      • Dnipropetrovsk, Ukraine, 49005
        • Study site
      • Kherson,Vil. Stepanivka, Ukraine, 73488
        • Study site
      • Kyiv, Ukraine, 02660
        • Study site
      • Kyiv, Ukraine, 04080
        • Study site
      • Kyiv, Ukraine, 04655
        • Study site
      • Simferopol, Ukraine, 95006
        • Study site
      • Vinnitsia, Ukraine, 21018
        • Study site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Study site
    • California
      • Escondido, California, United States, 92025
        • Study site
      • Garden Grove, California, United States, 92645
        • Study site
      • Long Beach, California, United States, 90813
        • Study site
      • Oceanside, California, United States, 92056
        • Study site
      • Pasadena, California, United States, 91107
        • Study site
      • San Diego, California, United States, 92123
        • Study site
      • San Diego, California, United States, 92102
        • Study site
      • Santa Ana, California, United States, 92701
        • Study site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Study site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Study site
      • Maitland, Florida, United States, 32751
        • Study site
    • Missouri
      • St. Louis, Missouri, United States, 63118
        • Study site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Study site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Study site
    • Texas
      • Austin, Texas, United States, 78756
        • Study site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: 5
Drug: Placebo
Placebo
EXPERIMENTAL: 1
OPC-34712 0.25 mg arm
Drug: OPC-34712
oral, once daily
EXPERIMENTAL: 2
OPC-34712 low-dose arm
Drug: OPC-34712
oral, once daily
EXPERIMENTAL: 3
OPC-34712 mid-dose arm
Drug: OPC-34712
oral, once daily
EXPERIMENTAL: 4
OPC-34712 high-dose arm
Drug: OPC-34712
oral, once daily
ACTIVE_COMPARATOR: 6
Aripiprazole arm
Drug: Aripiprazole
oral, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
Time Frame: Baseline to Week 6
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
Time Frame: Baseline to Week 6
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
Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
Time Frame: Baseline to Week 6
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
Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
Time Frame: Baseline to Week 6
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
Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
Time Frame: Baseline to Week 6
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
Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
Time Frame: 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
Response Rate at Week 6
Time Frame: 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
Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
Time Frame: Baseline to Week 6
Efficacy-related discontinuation rate was assessed
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331-07-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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