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CompletedNCT00905307STEP 203Updated Oct 20, 2015Results posted

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

A Phase 2 interventional study of OPC-34712 and Placebo in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 73 sites in 12 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
459
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • Relapsed
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 459 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
459 participants (actual)

Study arms

  • Experimental
    1

    OPC-34712 0.25 mg arm

    Drug: OPC-34712

  • Experimental
    2

    OPC-34712 low-dose arm

    Drug: OPC-34712

  • Experimental
    3

    OPC-34712 mid-dose arm

    Drug: OPC-34712

  • Experimental
    4

    OPC-34712 high-dose arm

    Drug: OPC-34712

  • Placebo comparator
    5

    Drug: Placebo

  • Active comparator
    6

    Aripiprazole arm

    Drug: Aripiprazole

Interventions

  • DrugOPC-34712

    oral, once daily

  • DrugPlacebo

    Placebo

  • DrugAripiprazole

    oral, once daily

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline to Week 6

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: Week 6

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

    Efficacy-related discontinuation rate was assessed

    Time frame: Baseline to Week 6

07

Results

Posted Sep 3, 2015

Participant flow

459 participants recruited at 74 study centres in the United States, Asia and Europe. Participants not responding adequately to treatment at Week 4 visit could continue in study and receive open-label OPC-34712 (starting dose 2.5 mg/day with option for decrease to 2 mg/day or increase to 3 mg/day) until Week 6 at study physician's discretion.

Participant flow — Overall Study
MilestoneOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High DoseAripiprazolePlacebo
Started428990935095
Completed205253563453
Not completed223737371642
Withdrew: Switched to open label rescue7171111415
Withdrew: Lost to follow-up000011
Withdrew: Adverse event3451135
Withdrew: Withdrawal by subject5131511413
Withdrew: Protocol violation101000
Withdrew: Lack of efficacy635448

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to Week 6
Reported as:
Mean · Units on a scale
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)-9.76 ± 19.29-18.73 ± 20.27-16.19 ± 18.55-18.25 ± 20.49-17.98 ± 21.32-14.40 ± 20.13
Statistical analysis
  • OPC-34712 Low-dose vs Placebo · ANCOVA · p = 0.2846 (The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.) · Treatment difference: -4.70 · 95% CI -10.2 to 0.82With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Mid-dose vs Placebo · ANCOVA · p = 0.6066 (The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.) · Treatment difference: -1.44 · 95% CI -6.96 to 4.07With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 High-dose vs Placebo · ANCOVA · p = 0.3293 (The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.) · Treatment difference: -3.86 · 95% CI -9.32 to 1.59With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 0.25 mg vs Placebo · ANCOVA · p = 0.2263 · Treatment difference: 4.62 · 95% CI -2.89 to 12.12With treatment and trial center as main effects, and baseline value as covariate
  • Aripiprazole vs Placebo · ANCOVA · p = 0.3074 · Treatment difference: -3.64 · 95% CI -10.7 to 3.38With treatment and trial center as main effects, and baseline value as covariate
SecondaryChange 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.

Time frame:
Baseline to Week 6
Reported as:
Mean · Units on a scale
Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)-3.22 ± 5.26-5.97 ± 7.12-4.94 ± 6.17-5.98 ± 6.72-6.60 ± 7.16-4.82 ± 6.34
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · ANCOVA · p = 0.1807 · Treatment difference: 1.61 · 95% CI -0.75 to 3.97With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Low-dose vs Placebo · ANCOVA · p = 0.1313 · Treatment difference: -1.41 · 95% CI -3.24 to 0.42With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Mid-dose vs Placebo · ANCOVA · p = 0.8879 · Treatment difference: -0.13 · 95% CI -1.96 to 1.69
  • OPC-34712 High-dose vs Placebo · ANCOVA · p = 0.1764 · Treatment difference: -1.24 · 95% CI -3.05 to 0.56With treatment and trial center as main effects, and baseline value as covariate
  • Aripiprazole vs Placebo · ANCOVA · p = 0.1111 · Treatment difference: -1.79 · 95% CI -4.00 to 0.42With treatment and trial center as main effects, and baseline value as covariate
SecondaryChange 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.

Time frame:
Baseline to Week 6
Reported as:
Mean · Units on a scale
Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)-1.93 ± 5.24-3.61 ± 5.15-3.84 ± 5.09-3.99 ± 5.40-3.00 ± 5.74-3.17 ± 4.88
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · ANCOVA · p = 0.2896 · Treatment difference: 1.00 · 95% CI -0.86 to 2.86With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Low-dose vs Placebo · ANCOVA · p = 0.3701 · Treatment difference: -0.61 · 95% CI -1.94 to 0.72With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Mid-dose vs Placebo · ANCOVA · p = 0.6074 · Treatment difference: -0.35 · 95% CI -1.69 to 0.99With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 High-dose vs Placebo · ANCOVA · p = 0.2777 · Treatment difference: -0.73 · 95% CI -2.05 to 0.59With treatment and trial center as main effects, and baseline value as covariate
  • Aripiprazole vs Placebo · ANCOVA · p = 0.8611 · Treatment difference: -0.15 · 95% CI -1.90 to 1.59With treatment and trial center as main effects, and baseline value as covariate
SecondaryChange 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.

Time frame:
Baseline to Week 6
Reported as:
Mean · Units on a scale
Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)4.54 ± 13.2511.36 ± 14.8410.67 ± 15.2112.17 ± 14.7210.66 ± 13.137.56 ± 14.90
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · ANCOVA · p = 0.3726 · Treatment difference: -2.36 · 95% CI -7.57 to 2.85With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Low-dose vs Placebo · ANCOVA · p = 0.0664 · Treatment difference: 3.80 · 95% CI -0.26 to 7.85With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Mid-dose vs Placebo · ANCOVA · p = 0.2944 · Treatment difference: 2.20 · 95% CI -1.92 to 6.32With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 High-dose vs Placebo · ANCOVA · p = 0.0596 · Treatment difference: 3.86 · 95% CI -0.16 to 7.89With treatment and trial center as main effects, and baseline value as covariate
  • Aripiprazole vs Placebo · ANCOVA · p = 0.1819 · Treatment difference: 3.25 · 95% CI -1.53 to 8.03With treatment and trial center as main effects, and baseline value as covariate
SecondaryChange 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

Time frame:
Baseline to Week 6
Reported as:
Mean · Units on a scale
Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)-0.39 ± 0.86-0.99 ± 1.29-0.87 ± 1.11-1.10 ± 1.24-1.00 ± 1.21-0.82 ± 1.16
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · ANCOVA · p = 0.0685 · Treatment difference: 0.38 · 95% CI -0.03 to 0.79With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Low-dose vs Placebo · ANCOVA · p = 0.0989 · Treatment difference: -0.28 · 95% CI -0.60 to 0.05With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 Mid-dose vs Placebo · ANCOVA · p = 0.8006 · Treatment difference: -0.04 · 95% CI -0.37 to 0.28With treatment and trial center as main effects, and baseline value as covariate
  • OPC-34712 High-dose vs Placebo · ANCOVA · p = 0.0898 · Treatment difference: -0.28 · 95% CI -0.60 to 0.04With treatment and trial center as main effects, and baseline value as covariate
  • Aripiprazole vs Placebo · ANCOVA · p = 0.2851 · Treatment difference: -0.21 · 95% CI -0.59 to 0.18With treatment and trial center as main effects, and baseline value as covariate
SecondaryMean 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.

Time frame:
Week 6
Reported as:
Mean · Units on a scale
Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
Units on a scaleOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Mean Clinical Global Impression - Improvement (CGI-I) at Week 63.66 ± 1.483.08 ± 1.583.17 ± 1.453.04 ± 1.503.04 ± 1.523.34 ± 1.54
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.4008The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score
  • OPC-34712 Low-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.1117The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score
  • OPC-34712 Mid-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.2739The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score
  • OPC-34712 High-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.1045The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score
  • Aripiprazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.1149The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score
SecondaryResponse 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

Time frame:
Week 6
Reported as:
Number · Percentage of participants
Response Rate at Week 6
Percentage of participantsOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Response Rate at Week 640.557.346.751.660.049.5
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.6200 · Relative risk: 0.89 · 95% CI 0.57 to 1.40CMH general association test controlling for study center will be applied to the analysis of response rate
  • OPC-34712 Low-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.1501 · Relative risk: 1.19 · 95% CI 0.95 to 1.48CMH general association test controlling for study center will be applied to the analysis of response rate
  • OPC-34712 Mid-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.5271 · Relative risk: 0.91 · 95% CI 0.66 to 1.25CMH general association test controlling for study center will be applied to the analysis of response rate
  • OPC-34712 High-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.8670 · Relative risk: 1.02 · 95% CI 0.78 to 1.34CMH general association test controlling for study center will be applied to the analysis of response rate
  • Aripiprazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.3892 · Relative risk: 1.15 · 95% CI 0.85 to 1.56CMH general association test controlling for study center will be applied to the analysis of response rate
SecondaryDiscontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712

Efficacy-related discontinuation rate was assessed

Time frame:
Baseline to Week 6
Reported as:
Number · Percentage of participants
Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
Percentage of participantsOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-347123122.517.816.116.024.2
Statistical analysis
  • OPC-34712 0.25 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.8540 (Derived using CMH test stratified by trial center.) · Relative risk: 1.06 · 95% CI 0.59 to 1.88
  • OPC-34712 Low-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.4492 (Derived using CMH test stratified by trial center.) · Relative risk: 0.82 · 95% CI 0.49 to 1.38
  • OPC-34712 Mid-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.1854 (Derived using CMH test stratified by trial center.) · Relative risk: 0.67 · 95% CI 0.36 to 1.23
  • OPC-34712 High-dose vs Placebo · Cochran-Mantel-Haenszel · p = 0.0946 (Derived using CMH test stratified by trial center.) · Relative risk: 0.61 · 95% CI 0.33 to 1.10
  • Aripiprazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.2133 (Derived using CMH test stratified by trial center.) · Relative risk: 0.63 · 95% CI 0.30 to 1.34

Adverse events

Collected over Adverse events (AEs) were recorded from the time of signing the informed consent, during the 6-week treatment period and up to 30 days after the last dose of study medication. The AEs presented are for the double blind phase.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OPC-34712 0.25 mg—0/42 (0%)20/42 (47.6%)
OPC-34712 Low-dose—3/89 (3.4%)41/89 (46.1%)
OPC-34712 Mid-dose—5/90 (5.6%)36/90 (40%)
OPC-34712 High-dose—4/93 (4.3%)52/93 (55.9%)
Aripiprazole—2/50 (4%)22/50 (44%)
Placebo—3/95 (3.2%)39/95 (41.1%)
Most frequent serious events
Most frequent serious events
EventOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
RhabdomyolysisMusculoskeletal and connective tissue disorders0/421/891/900/931/500/95
Complex partial seizuresNervous system disorders0/420/890/900/931/500/95
Ankle fractureInjury, poisoning and procedural complications0/421/890/900/930/500/95
SchizophreniaPsychiatric disorders0/421/891/901/930/501/95
HypoglycaemiaMetabolism and nutrition disorders0/420/891/900/930/500/95
DizzinessNervous system disorders0/420/891/900/930/500/95
Schizophrenia, paranoid typePsychiatric disorders0/420/891/901/930/500/95
DeathGeneral disorders0/420/890/901/930/500/95
Psychotic disorderPsychiatric disorders0/420/890/901/930/501/95
AnxietyPsychiatric disorders0/420/890/900/930/501/95
Most frequent other events
Showing 10 of 18
Most frequent other events
EventOPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlacebo
InsomniaPsychiatric disorders4/4212/899/909/934/5016/95
AkathisiaNervous system disorders1/426/895/9014/932/504/95
HeadacheNervous system disorders6/428/8913/907/933/5010/95
AnxietyPsychiatric disorders5/427/896/9010/935/5010/95
Weight increasedInvestigations1/426/899/906/933/503/95
AgitationPsychiatric disorders4/424/894/907/935/504/95
DyspepsiaGastrointestinal disorders4/424/893/904/931/507/95
ConstipationGastrointestinal disorders2/424/892/906/931/508/95
DiarrhoeaGastrointestinal disorders3/425/891/904/934/503/95
NauseaGastrointestinal disorders1/424/897/906/931/502/95

Baseline characteristics

Age, Continuous
Age, Continuous(Years)OPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlaceboTotal
Mean40.4 ± 9.139.2 ± 10.337.4 ± 11.139.5 ± 11.140.8 ± 1138.8 ± 11.439.1 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)OPC-34712 0.25 mgOPC-34712 Low-doseOPC-34712 Mid-doseOPC-34712 High-doseAripiprazolePlaceboTotal
Female153630381637172
Male275360553458287
08

Study locations

73 sites
  • Study Site
    Little Rock, Arkansas 72211, United States
  • Study Site
    Escondido, California 92025, United States
  • Study Site
    Garden Grove, California 92645, United States
  • Study Site
    Long Beach, California 90813, United States
  • Study Site
    Oceanside, California 92056, United States
  • Study Site
    Pasadena, California 91107, United States
  • Study Site
    San Diego, California 92102, United States
  • Study Site
    San Diego, California 92123, United States
  • Study Site
    Santa Ana, California 92701, United States
  • Study Site
    Washington, District of Columbia 20016, United States
  • Study Site
    Bradenton, Florida 34208, United States
  • Study Site
    Maitland, Florida 32751, United States
  • Study Site
    St. Louis, Missouri 63118, United States
  • Study Site
    Cedarhurst, New York 11516, United States
  • Study Site
    Philadelphia, Pennsylvania 19139, United States
  • Study Site
    Austin, Texas 78756, United States
  • Study Site
    Burgas, 8000, Bulgaria
  • Study Site
    Kazanlak, 6100, Bulgaria
  • Study Site
    Pazardzhik, 4400, Bulgaria
  • Study Site
    Plovdiv, 4002, Bulgaria
  • Study Site
    Radnevo, 6260, Bulgaria
  • Study Site
    Ruse, 7003, Bulgaria
  • Study Site
    Rijeka, 51000, Croatia
  • Study Site
    Split, 21000, Croatia
  • Study Site
    Zagreb, 10090, Croatia
  • Study Site
    Vijaywada, Andh Prad 520002, India
  • Study Site
    Visakhapatnam, Andh Prad 530017, India
  • Study Site
    Ahmedabad, Gujarat 380015, India
  • Study Site
    Bangalore, Karna 560010, India
  • Study Site
    Mangalore, Karna 575001, India
  • Study Site
    Mangalore, Karna 575018, India
  • Study Site
    Pune, Mahara 411004, India
  • Study Site
    Chennai, Tamilnadu 600003, India
  • Study Site
    Varanasi, Uttar Prad 221005, India
  • Study Site
    Busan, 613-735, Korea, Republic of
  • Study Site
    Chuncheon, 200-704, Korea, Republic of
  • Study Site
    Incheon, 400-711, Korea, Republic of
  • Study Site
    Incheon, 405-760, Korea, Republic of
  • Study Site
    Seoul, 143-711, Korea, Republic of
  • Study Site
    Cebu City 6000, Philippines
  • Study Site
    Mandaluyong City 1553, Philippines
  • Study Site
    Arad, 310022, Romania
  • Study Site
    Bucuresti, 010825, Romania
  • Study Site (1)
    Bucuresti, 041914, Romania
  • Study Site (2)
    Bucuresti, 041914, Romania
  • Study Site (3)
    Bucuresti, 041914, Romania
  • Study Site
    Cluj-Napoca, 400012, Romania
  • Study Site
    Oradea, 410154, Romania
  • Study Site
    Moscow Region, 141371, Russian Federation
  • Study Site
    Moscow, 113152, Russian Federation
  • Study Site
    Moscow, 115522, Russian Federation
  • Study Site
    St. Petersburg, 190121, Russian Federation
  • Study Site
    St. Petersburg, 193167, Russian Federation
  • Study Site
    St. Petersburg, 197341, Russian Federation
  • Study Site (1)
    Belgrade, 11000, Serbia
  • Study Site (2)
    Belgrade, 11000, Serbia
  • Study Site
    Kragujevac, 34000, Serbia
  • Study Site
    Novi Sad, 21000, Serbia
  • Study Site
    Bojnice, 92701, Slovakia
  • Study Site
    Bratislava, 82606, Slovakia
  • Study Site
    Liptovsky Mikulas, 03123, Slovakia
  • Study Site
    Rimavska Sobota, 97912, Slovakia
  • Study Site
    Zilina, 01207, Slovakia
  • Study Site
    Hualien Town, 970, Taiwan
  • Study Site
    Taipei, 249, Taiwan
  • Study Site
    Chernigiv, 14005, Ukraine
  • Study Site
    Dnipropetrovsk, 49005, Ukraine
  • Study Site
    Kherson,Vil. Stepanivka, 73488, Ukraine
  • Study Site
    Kyiv, 02660, Ukraine
  • Study Site
    Kyiv, 04080, Ukraine
  • Study Site
    Kyiv, 04655, Ukraine
  • Study Site
    Simferopol, 95006, Ukraine
  • Study Site
    Vinnitsia, 21018, Ukraine
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00905307
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
May 20, 2009
Start date
Jul 2009
Primary completion
Sep 2010
Completion
Nov 2010
Results posted
Sep 3, 2015
Last update
Oct 20, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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