Trial · NCT01397786
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
NCT01397786, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2017-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia. Trials, record NCT01397786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01397786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
- NCT number
- NCT01397786
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,044 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- OPC-34712
- First posted
- 2011-07-20
- Last updated
- 2017-05-10
- Results first posted
- 2017-03-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) | From Baseline up to 52 Weeks | A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP. |
| Secondary | Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score | From Baseline up to 52 Weeks | The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) \& 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel. |
| Secondary | Mean Change From Baseline in PANSS Positive Subscale Score | From Baseline up to 52 Weeks | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. |
| Secondary | Mean Change From Baseline in PANSS Negative Subscale Score | From Baseline up to 52 Weeks | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 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. |
| Secondary | Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score | From Baseline up to 52 Weeks | The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices include: 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. |
| Secondary | Mean Change From Baseline in Personal and Social Performance Scale Total Score | From Baseline up to 52 Weeks | The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then 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 that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision. |
| Secondary | Mean Clinical Global Impression - Improvement Score | From Baseline up to 52 Weeks | The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). 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. |
| Secondary | Response Rate | From Baseline up to 52 Weeks | Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit. |
| Secondary | Discontinuation Rate for Lack of Efficacy | From Baseline up to 52 Weeks | Discontinuation rate for the participants who discontinued due to lack of efficacy were examined. |
| Secondary | Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score | From Baseline up to 52 Weeks | The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | From Baseline up to 52 Weeks | Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in PANSS Positive Subscale Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in PANSS Negative Subscale Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Personal and Social Performance Scale Total Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Mean Clinical Global Impression - Improvement Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
| SECONDARY | Response Rate | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | percentage of participants | NUMBER |
| SECONDARY | Discontinuation Rate for Lack of Efficacy | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score | From Baseline up to 52 Weeks | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Prior Brexpiprazole | With AEs | 60.2 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Prior Placebo | With AEs | 56.4 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | De Novo | With AEs | 65.2 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Total | With AEs | 60.5 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Prior Brexpiprazole | With TEAEs | 60.0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Prior Placebo | With TEAEs | 56.4 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | De Novo | With TEAEs | 65.2 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Total | With TEAEs | 60.4 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Prior Brexpiprazole | With SAEs | 14.9 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) | Prior Placebo | With SAEs | 8.9 | percentage of participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A | STARTED | Prior Brexpiprazole | 12 | |
| Phase A | STARTED | Prior Placebo | 0 | |
| Phase A | STARTED | De Novo | 227 | |
| Phase A | COMPLETED | Prior Brexpiprazole | 12 | |
| Phase A | COMPLETED | Prior Placebo | 0 | |
| Phase A | COMPLETED | De Novo | 199 | |
| Phase A | NOT COMPLETED | Prior Brexpiprazole | 0 | |
| Phase A | NOT COMPLETED | Prior Placebo | 0 | |
| Phase A | NOT COMPLETED | De Novo | 28 | |
| Phase B | STARTED | Prior Brexpiprazole | 611 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Weight increased | Investigations | De Novo (Phase A) | 0 | 226 | |
| other | Weight increased | Investigations | Prior Brexpiprazole (Phase B) | 47 | 605 | |
| other | Weight increased | Investigations | Prior Placebo (Phase B) | 15 | 202 | |
| other | Weight increased | Investigations | De Novo (Phase B) | 23 | 256 | |
| other | Akathisia | Nervous system disorders | De Novo (Phase A) | 0 | 226 | |
| other | Akathisia | Nervous system disorders | Prior Brexpiprazole (Phase B) | 22 | 605 | |
| other | Akathisia | Nervous system disorders | Prior Placebo (Phase B) | 14 | 202 | |
| other | Akathisia | Nervous system disorders | De Novo (Phase B) | 14 | 256 | |
| other | Headache | Nervous system disorders | De Novo (Phase A) | 0 | 226 | |
| other | Headache | Nervous system disorders | Prior Brexpiprazole (Phase B) | 42 | 605 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | De Novo (Phase A) | ||
| Total, all-cause mortality | Prior Brexpiprazole (Phase B) | ||
| Total, all-cause mortality | Prior Placebo (Phase B) | ||
| Total, all-cause mortality | De Novo (Phase B) | ||
| Total, other adverse events | De Novo (Phase A) | 0 | 226 |
| Total, other adverse events | Prior Brexpiprazole (Phase B) | 166 | 605 |
| Total, other adverse events | Prior Placebo (Phase B) | 53 | 202 |
| Total, other adverse events | De Novo (Phase B) | 95 | 256 |
| Total, serious adverse events | De Novo (Phase A) | 4 | 226 |
| Total, serious adverse events | Prior Brexpiprazole (Phase B) | 90 | 605 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01397786/results?page=2