AzTrials
AzTrials

SchizophreniaPhase 2STEP 203NCT00905307

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

A Phase 2 study testing OPC-34712 and Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
OPC-34712 and Aripiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
459 participants
Where
73 sitesin 12 countries
Study dates
Jul 2009to Nov 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

73 sites in 12 countries.

73 sites in 12 countries

United States16 sites

  • Study Site

    Austin, Texas, 78756

  • Study Site

    Bradenton, Florida, 34208

  • Study Site

    Cedarhurst, New York, 11516

  • Study Site

    Escondido, California, 92025

  • Study Site

    Garden Grove, California, 92645

  • Study Site

    Little Rock, Arkansas, 72211

  • Study Site

    Long Beach, California, 90813

  • Study Site

    Maitland, Florida, 32751

  • Study Site

    Oceanside, California, 92056

  • Study Site

    Pasadena, California, 91107

  • Study Site

    Philadelphia, Pennsylvania, 19139

  • Study Site

    San Diego, California, 92102

  • Study Site

    San Diego, California, 92123

  • Study Site

    Santa Ana, California, 92701

  • Study Site

    St Louis, Missouri, 63118

  • Study Site

    Washington D.C., District of Columbia, 20016

Other trials in United States

India9 sites

  • Study Site

    Ahmedabad, Gujarat, 380015

  • Study Site

    Bangalore, Karna, 560010

  • Study Site

    Chennai, Tamil Nadu, 600003

  • Study Site

    Mangalore, Karna, 575001

  • Study Site

    Mangalore, Karna, 575018

  • Study Site

    Pune, Mahara, 411004

  • Study Site

    Varanasi, Uttar Prad, 221005

  • Study Site

    Vijaywada, Andh Prad, 520002

  • Study Site

    Visakhapatnam, Andh Prad, 530017

Other trials in India

Ukraine8 sites

  • Study Site

    Chernihiv, 14005

  • Study Site

    Dnipropetrovsk, 49005

  • Study Site

    Kherson,Vil. Stepanivka, 73488

  • Study Site

    Kyiv, 02660

  • Study Site

    Kyiv, 04080

  • Study Site

    Kyiv, 04655

  • Study Site

    Simferopol, 95006

  • Study Site

    Vinnitsia, 21018

Other trials in Ukraine

Romania7 sites

  • Study Site

    Arad, 310022

  • Study Site

    Bucharest, 010825

  • Study Site (1)

    Bucharest, 041914

  • Study Site (2)

    Bucharest, 041914

  • Study Site (3)

    Bucharest, 041914

  • Study Site

    Cluj-Napoca, 400012

  • Study Site

    Oradea, 410154

Other trials in Romania

Bulgaria6 sites

  • Study Site

    Burgas, 8000

  • Study Site

    Kazanlak, 6100

  • Study Site

    Pazardzhik, 4400

  • Study Site

    Plovdiv, 4002

  • Study Site

    Radnevo, 6260

  • Study Site

    Rousse, 7003

Other trials in Bulgaria

Russia6 sites

  • Study Site

    Moscow, 113152

  • Study Site

    Moscow, 115522

  • Study Site

    Moscow Region, 141371

  • Study Site

    Saint Petersburg, 190121

  • Study Site

    Saint Petersburg, 193167

  • Study Site

    Saint Petersburg, 197341

Other trials in Russia

Slovakia5 sites

  • Study Site

    Bojnice, 92701

  • Study Site

    Bratislava, 82606

  • Study Site

    Liptovský Mikuláš, 03123

  • Study Site

    Rimavská Sobota, 97912

  • Study Site

    Žilina, 01207

Other trials in Slovakia

South Korea5 sites

  • Study Site

    Busan, 613-735

  • Study Site

    Chuncheon, 200-704

  • Study Site

    Incheon, 400-711

  • Study Site

    Incheon, 405-760

  • Study Site

    Seoul, 143-711

Other trials in South Korea

Serbia4 sites

  • Study Site (1)

    Belgrade, 11000

  • Study Site (2)

    Belgrade, 11000

  • Study Site

    Kragujevac, 34000

  • Study Site

    Novi Sad, 21000

Other trials in Serbia

Croatia3 sites

  • Study Site

    Rijeka, 51000

  • Study Site

    Split, 21000

  • Study Site

    Zagreb, 10090

Other trials in Croatia

Philippines2 sites

  • Study Site

    Cebu City

  • Study Site

    Mandaluyong

Other trials in Philippines

Taiwan2 sites

  • Study Site

    Hualien Town, 970

  • Study Site

    Taipei, 249

Other trials in Taiwan

About this study

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

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.

Conditions
Schizophrenia
Being tested
OPC-34712, Placebo, Aripiprazole
Keywords
Schizophrenia, Relapsed
Medical subject headings
Schizophrenia, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPC-34712Drug

    oral, once daily

  • PlaceboDrug

    Placebo

  • AripiprazoleDrug

    oral, once daily

Study groups in NCT00905307
Study groupRoleWhat they receive
1ExperimentalOPC-34712 0.25 mg arm
Receives: Drug: OPC-34712
2ExperimentalOPC-34712 low-dose arm
Receives: Drug: OPC-34712
3ExperimentalOPC-34712 mid-dose arm
Receives: Drug: OPC-34712
4ExperimentalOPC-34712 high-dose arm
Receives: Drug: OPC-34712
5Placebo comparatorNot described
Receives: Drug: Placebo
6Active comparatorAripiprazole arm
Receives: Drug: Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 6

Secondary outcomes (7)

  1. 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.

    Measured: Baseline to Week 6

  2. 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.

    Measured: Baseline to Week 6

  3. 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.

    Measured: Baseline to Week 6

  4. 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

    Measured: Baseline to Week 6

  5. 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.

    Measured: Week 6

  6. 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

    Measured: Week 6

  7. Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712

    Efficacy-related discontinuation rate was assessed

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00905307
Sponsor's protocol ID
331-07-203
Acronym
STEP 203
Status last verified
Sep 2015
First submitted
19 May 2009
Last updated
20 Oct 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27188270

  • 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.

    PubMed 26250067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC-34712 and Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, India, Ukraine, Romania, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase) (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00905307, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in