SchizophreniaPhase 2/3NCT01451164

A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

A Phase 2/3 study testing OPC-34712 in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with 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
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: 1 siteJapan
Study dates: Oct 2011to Jun 2015
Phase: Phase 2/3
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

Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
Patients who are experiencing acute exacerbation of psychotic symptoms

Who cannot join

Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kanto Region

Other trials in Japan

About this study

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Conditions: Schizophrenia
Being tested: OPC-34712, Placebo
Medical subject headings: Schizophrenia

What participants receive

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

OPC-34712Drug
orally administered once daily
OPC-34712Drug
orally administered once daily
OPC-34712Drug
orally administered once daily
PlaceboDrug
orally administered once daily

Study groups in NCT01451164
Study group	Role	What they receive
High dose	Experimental	Not described Receives: Drug: OPC-34712
Mid dose	Experimental	Not described Receives: Drug: OPC-34712
Low dose	Experimental	Not described Receives: Drug: OPC-34712
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was 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 ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Measured: Baseline, Weeks 1, 2, 3, 4, 5, and 6

Secondary outcomes (4)

Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
Measured: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. 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. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
Measured: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 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; and 7 = among the most extremely ill participants.
Measured: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is 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: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Measured: Baseline, Weeks 1, 2, 3, 4, 5, and 6

Timeline

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

Oct 2011Jun 2015

First posted13 Oct 2011 (estimated)
Study startOct 2011
Primary completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01451164
Sponsor's protocol ID: 331-10-002
Other IDs: JapicCTI-111631
Status last verified: Oct 2016
First submitted: 11 Oct 2011
Last updated: 3 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT01451164
Acronym / sponsor ID: 331-10-002
Conditions: Schizophrenia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Jun 2015 (actual)
First posted: 13 Oct 2011 (estimated)
Results: Posted 3 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High dose	Experimental	Drug: OPC-34712
Mid dose	Experimental	Drug: OPC-34712
Low dose	Experimental	Drug: OPC-34712
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
Patients who are experiencing acute exacerbation of psychotic symptoms

Key exclusion criteria (3 listed)

Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-34712orally administered once daily	Drug	High dose
OPC-34712orally administered once daily	Drug	Mid dose
OPC-34712orally administered once daily	Drug	Low dose
Placeboorally administered once daily	Drug	Placebo

Primary outcome

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was 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 ranged from 30 (best possible outcome) to 210 (worst possible outcome).

4 secondary outcomes

Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6

Results and safety

Results posted to the registry on 3 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brexpiprazole 1mg	115	72
Brexpiprazole 2mg	115	81
Brexpiprazole 4mg	113	68
Placebo	116	70

Primary outcome: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6. Least squares mean (Standard Error). Unit: units on a scale

Measure	Brexpiprazole 1mg n = 112	Brexpiprazole 2mg n = 113	Brexpiprazole 4mg n = 109	Placebo n = 113
Week1	-2.68 (1.04)	-4.59 (1.03)	-3.42 (1.05)	-3.09 (1.03)
Week2	-5.07 (1.36)	-7.93 (1.33)	-6.80 (1.36)	-4.54 (1.34)
Week3	-6.92 (1.60)	-11.00 (1.55)	-9.42 (1.59)	-6.00 (1.58)
Week4	-8.40 (1.81)	-12.35 (1.74)	-11.21 (1.80)	-5.67 (1.80)
Week5	-8.13 (2.02)	-13.97 (1.93)	-11.09 (2.01)	-6.62 (2.03)
Week6	-8.26 (2.10)	-14.95 (2.00)	-11.49 (2.10)	-7.63 (2.11)

Population analysed: Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brexpiprazole 1mg	8 of 115 (7%)	49 of 115 (42.6%)	0 of 115
Brexpiprazole 2mg	5 of 114 (4.4%)	46 of 114 (40.4%)	0 of 114
Brexpiprazole 4mg	5 of 113 (4.4%)	49 of 113 (43.4%)	0 of 113
Placebo	5 of 116 (4.3%)	56 of 116 (48.3%)	0 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

kyoji Imaoka, Operating Officer study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing OPC-34712 in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 3 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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Oct 2019). 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?

Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline, Weeks 1, 2, 3, 4, 5, and 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 NCT01451164.

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 3 Oct 2019.