A Phase 2 interventional study of OPC-34712 in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 71 sites in 12 countries. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 244 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →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.
Exclusion Criteria:
Drug: OPC-34712
oral administered once daily
Number of Participants With Adverse Events (AEs) During First 6 Weeks.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time frame: From Baseline up to 6 weeks
Number of Participants With AEs in 52-Week Enrollers.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time frame: From Baseline up to 52 weeks
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
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 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
The severity of illness for each participant were 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.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
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.
Time frame: Baseline, Week 1, 2, 6, 26, 52 and Last Visit
Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants 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.
Time frame: Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Change From Baseline in PANSS Positive Subscale Score.
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. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Change From Baseline in PANSS Negative Subscale Score.
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. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Percentage of Participants With a Positive Response Rate.
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.
Time frame: Last Visit
Percentage of Participants Who Discontinued Due to Lack of Efficacy.
Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
Time frame: Last Visit
The protocol was initially approved as a 6-week trial and later extended to a 52-week trial (Amendment 2). The trial enrolled 244 participants at 73 sites in 12 countries. Of the 244 participants, 28 were included in the 52-week enrollment population.
| Milestone | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Started | 179 | 41 | 24 |
| 6-week enrollers | 159 | 35 | 22 |
| 52-week enrollers | 20 | 6 | 2 |
| Completed | 135 | 27 | 15 |
| Not completed | 44 | 14 | 9 |
| Withdrew: Lost to follow-up | 5 | 0 | 3 |
| Withdrew: Adverse event | 7 | 5 | 1 |
| Withdrew: Met withdrawal criteria | 4 | 0 | 0 |
| Withdrew: Physician decision | 8 | 2 | 1 |
| Withdrew: Withdrawal by subject | 15 | 5 | 4 |
| Withdrew: Protocol deviation | 0 | 2 | 0 |
| Withdrew: Lack of efficacy | 5 | 0 | 0 |
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
| Participants | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Participants with AEs | 79 | 19 | 7 |
| Participants with TEAEs | 78 | 19 | 7 |
| Participants with serious TEAEs | 4 | 6 | 1 |
| Participants with severe TEAEs | 2 | 3 | 2 |
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
| Participants | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Participants with AEs | 15 | 4 | 2 |
| Participants with TEAEs | 15 | 4 | 2 |
| Participants with serious TEAEs | 0 | 0 | 0 |
| Participants with severe TEAEs | 0 | 1 | 0 |
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 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Day 4 (N= 169, 36, 22) | 0.11 ± 5.86 | -1.25 ± 3.97 | -1.50 ± 4.97 |
| Week 1 (N= 167, 40, 23) | -2.03 ± 5.49 | -1.53 ± 7.95 | -1.91 ± 6.22 |
| Week 2 (N= 165, 40, 21) | -2.95 ± 8.80 | -3.43 ± 10.68 | -1.86 ± 6.04 |
| Week 4 (N=148, 34, 18) | -4.65 ± 8.59 | -4.71 ± 12.85 | -5.39 ± 6.30 |
| Week 6 (N= 138, 31, 15) | -7.51 ± 8.82 | -7.87 ± 10.26 | -7.47 ± 7.22 |
| Week 8 (N=20, 6, 2) | -8.80 ± 8.69 | -5.17 ± 7.55 | -10.00 ± 1.41 |
| Week 14 (N=20, 6, 2) | -9.85 ± 8.09 | 6.83 ± 28.29 | -3.50 ± 12.02 |
| Week 20 (N= 20, 5, 2) | -10.20 ± 9.12 | -4.60 ± 10.71 | -6.50 ± 10.61 |
| Week 26 (N= 19, 5, 2) | -12.89 ± 9.34 | -5.80 ± 11.56 | -10.50 ± 7.78 |
| Week 32 (N= 18, 5, 2) | -14.67 ± 10.94 | -3.00 ± 16.90 | -16.00 ± 0.00 |
| Week 38 (N= 17, 3, 2) | -13.24 ± 10.97 | -4.67 ± 10.21 | -13.00 ± 0.00 |
| Week 44 (N= 17, 2, 2) | -16.00 ± 10.28 | -4.50 ± 12.02 | -11.50 ± 2.12 |
| Week 52 (N= 16, 2, 2) | -15.00 ± 10.06 | -5.50 ± 13.44 | -11.00 ± 7.07 |
| Last visit (N= 176, 41, 23) | -5.99 ± 11.25 | -2.32 ± 18.97 | -5.96 ± 8.27 |
The severity of illness for each participant were 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.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Day 4 (N= 169, 36, 22) | 0.02 ± 0.51 | -0.03 ± 0.29 | 0.05 ± 0.38 |
| Week 1 (N= 167, 40, 23) | -0.08 ± 0.47 | -0.05 ± 0.60 | -0.04 ± 0.37 |
| Week 2 (N= 164, 40, 21) | -0.12 ± 0.63 | -0.18 ± 0.71 | 0.00 ± 0.32 |
| Week 4 (N= 148, 34, 18) | -0.25 ± 0.64 | -0.24 ± 0.82 | -0.22 ± 0.43 |
| Week 6 (N= 139, 31, 15) | -0.40 ± 0.66 | -0.35 ± 0.80 | -0.33 ± 0.49 |
| Week 8 (N= 20, 6, 2) | -0.20 ± 0.77 | 0.17 ± 0.41 | 0.00 ± 0.00 |
| Week 14 (N= 20, 6, 2) | -0.40 ± 0.68 | 0.83 ± 1.60 | 0.50 ± 0.71 |
| Week 20 (N= 20, 5, 2) | -0.55 ± 0.76 | 0.20 ± 0.45 | 0.00 ± 0.00 |
| Week 26 (N= 19, 5, 2) | -0.63 ± 0.90 | 0.00 ± 0.71 | 0.00 ± 0.00 |
| Week 32 (N= 18, 5, 2) | -0.78 ± 0.81 | 0.20 ± 1.10 | -0.50 ± 0.71 |
| Week 38 (N= 17, 3, 2) | -0.71 ± 0.85 | 0.00 ± 0.00 | -0.50 ± 0.71 |
| Week 44 (N= 17, 2, 2) | -0.82 ± 0.81 | 0.00 ± 0.00 | -0.50 ± 0.71 |
| Week 52 (N= 16, 2, 2) | -0.88 ± 0.81 | 0.00 ± 0.00 | -0.50 ± 0.71 |
| Last visit (N= 176, 41, 23) | -0.33 ± 0.83 | -0.15 ± 1.20 | -0.30 ± 0.56 |
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.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Week 1 (N= 5, 1, 1) | -2.00 ± 4.82 | -21.00 ± 0 | -5.00 ± 0 |
| Week 2 (N= 163, 40, 21) | 1.00 ± 7.11 | 1.50 ± 8.16 | 0.00 ± 0.00 |
| Week 6 (N= 139, 31, 15) | 5.00 ± 9.34 | 6.00 ± 10.86 | 1.00 ± 5.96 |
| Week 26 (N= 19, 5, 2) | 6.00 ± 5.35 | 12.00 ± 8.07 | 2.50 ± 3.54 |
| Week 52 (N= 16, 2, 2) | 13.00 ± 7.31 | 13.00 ± 1.41 | 0.50 ± 0.71 |
| Last visit (N= 171, 41, 22) | 4.00 ± 10.28 | 5.00 ± 15.10 | 1.00 ± 5.32 |
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants 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.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Day 4 (N= 169, 36, 22) | 3.70 ± 0.87 | 3.56 ± 0.88 | 3.23 ± 1.15 |
| Week 1 (N= 167, 40, 23) | 3.51 ± 0.89 | 3.73 ± 0.93 | 3.13 ± 1.14 |
| Week 2 (N= 164, 40, 21) | 3.41 ± 1.10 | 3.45 ± 1.28 | 3.38 ± 1.28 |
| Week 4 (N= 148, 34, 18) | 3.14 ± 1.04 | 3.26 ± 1.21 | 2.94 ± 1.21 |
| Week 6 (N= 139, 31, 15) | 2.86 ± 0.99 | 3.03 ± 1.28 | 2.60 ± 1.18 |
| Week 8 (N= 20, 6, 2) | 2.80 ± 0.95 | 3.50 ± 1.22 | 3.00 ± 1.41 |
| Week 14 (N= 20, 6, 2) | 2.75 ± 0.85 | 3.83 ± 1.60 | 4.50 ± 0.71 |
| Week 20 (N= 20, 5, 2) | 2.70 ± 1.03 | 3.20 ± 1.30 | 4.00 ± 0.00 |
| Week 26 (N= 19, 5, 2) | 2.74 ± 0.93 | 3.00 ± 1.41 | 4.00 ± 0.00 |
| Week 32 (N= 18, 5, 2) | 2.56 ± 0.78 | 3.20 ± 1.79 | 3.00 ± 1.41 |
| Week 38 (N= 17, 3, 2) | 2.53 ± 0.87 | 2.67 ± 1.15 | 3.00 ± 1.41 |
| Week 44 (N= 17, 2, 2) | 2.35 ± 0.79 | 3.00 ± 1.41 | 3.00 ± 1.41 |
| Week 52 (N= 16, 2, 2) | 2.31 ± 0.79 | 3.00 ± 1.41 | 3.00 ± 1.41 |
| Last visit (N= 176, 41, 23) | 3.04 ± 1.14 | 3.32 ± 1.52 | 2.83 ± 1.19 |
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. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Day 4 (N= 169, 36, 22) | -0.04 ± 2.06 | -0.50 ± 1.36 | 0.09 ± 2.24 |
| Week 1 (N= 167, 40, 23) | -0.66 ± 1.91 | -0.25 ± 2.72 | -0.78 ± 2.76 |
| Week 2 (N= 165, 40, 21) | -1.09 ± 2.92 | -0.70 ± 3.75 | -0.05 ± 2.84 |
| Week 4 (N= 148, 34, 18) | -1.53 ± 2.96 | -1.06 ± 3.95 | -1.11 ± 2.08 |
| Week 6 (N= 138, 31, 15) | -2.36 ± 3.21 | -2.03 ± 3.06 | -1.87 ± 2.39 |
| Week 8 (N= 20, 6, 2) | -2.10 ± 3.02 | -1.67 ± 2.34 | -2.50 ± 2.12 |
| Week 14 (20, 6, 2) | -2.80 ± 2.65 | 2.17 ± 9.04 | 1.00 ± 4.24 |
| Week 20 (20, 5, 2) | -2.60 ± 3.49 | -1.80 ± 2.39 | 0.00 ± 4.24 |
| Week 26 (N= 19, 5, 2) | -3.42 ± 2.99 | -2.60 ± 2.61 | -3.00 ± 1.41 |
| Week 32 (N= 18, 5, 2) | -3.83 ± 3.54 | -1.00 ± 4.85 | -5.00 ± 1.41 |
| Week 38 (N= 17, 3, 2) | -3.71 ± 4.10 | -2.67 ± 2.52 | -3.00 ± 0.00 |
| Week 44 (N= 17, 2, 2) | -4.24 ± 3.53 | -1.50 ± 2.12 | -4.00 ± 1.41 |
| Week 52 (N= 16, 2, 2) | -3.63 ± 3.74 | -1.50 ± 2.12 | -4.50 ± 3.54 |
| Last visit (N= 176, 41, 23) | -1.74 ± 3.86 | -0.22 ± 6.04 | -1.43 ± 2.87 |
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. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
| Units on a scale | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Day 4 (N= 169, 36, 22) | -0.01 ± 1.99 | -0.25 ± 1.00 | -0.86 ± 2.12 |
| Week 1 (N= 167, 40, 23) | -0.47 ± 2.15 | -0.40 ± 2.58 | -0.87 ± 2.44 |
| Week 2 (N= 165, 40, 21) | -0.68 ± 2.61 | -0.83 ± 2.32 | -1.19 ± 2.52 |
| Week 4 (N= 148, 34, 18) | -1.03 ± 2.99 | -1.35 ± 3.02 | -1.94 ± 2.48 |
| Week 6 (N= 138, 31, 15) | -1.70 ± 3.04 | -1.97 ± 2.70 | -2.40 ± 2.61 |
| Week 8 (N= 20, 6, 2) | -2.55 ± 2.68 | -1.00 ± 2.00 | -1.00 ± 1.41 |
| Week 14 (N= 20, 6, 2) | -2.85 ± 3.15 | 1.17 ± 7.05 | -1.50 ± 2.12 |
| Week 20 (N= 20, 5, 2) | -3.00 ± 3.04 | -0.60 ± 1.14 | -2.00 ± 2.83 |
| Week 26 (N= 19, 5, 2) | -3.74 ± 3.43 | -1.20 ± 1.48 | -2.50 ± 2.12 |
| Week 32 (N= 18, 5, 2) | -4.00 ± 4.41 | -1.00 ± 1.87 | -2.50 ± 3.54 |
| Week 38 (N= 17, 3, 2) | -3.94 ± 3.93 | -0.67 ± 2.08 | -2.50 ± 3.54 |
| Week 44 (N= 17, 2, 2) | -4.18 ± 3.61 | -1.00 ± 2.83 | -2.50 ± 3.54 |
| Week 52 (N= 16, 2, 2) | -4.00 ± 3.58 | -1.00 ± 2.83 | -2.00 ± 1.41 |
| Last visit (N= 176, 41, 23) | -1.53 ± 3.28 | -1.10 ± 3.85 | -2.09 ± 2.59 |
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.
| Percentage of participants | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Percentage of Participants With a Positive Response Rate. | 33.5 | 36.6 | 45.8 |
Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
| Percentage of participants. | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| Percentage of Participants Who Discontinued Due to Lack of Efficacy. | 2.8 | 0.0 | 0.0 |
Collected over AEs were recorded from Screening (ICF was signed) to Follow-up 30 (± 2) days, up to 52 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior Brexpiprazole | — | 4/178 (2.2%) | 31/178 (17.4%) |
| Prior Placebo | — | 6/41 (14.6%) | 10/41 (24.4%) |
| Prior Aripiprazole | — | 1/23 (4.3%) | 4/23 (17.4%) |
| Event | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| SchizophreniaPsychiatric disorders | 2/178 | 3/41 | 0/23 |
| Psychotic disorderPsychiatric disorders | 2/178 | 1/41 | 1/23 |
| BronchitisInfections and infestations | 0/178 | 1/41 | 0/23 |
| InfluenzaInfections and infestations | 0/178 | 1/41 | 0/23 |
| ConvulsionNervous system disorders | 0/178 | 1/41 | 0/23 |
| Event | Prior Brexpiprazole | Prior Placebo | Prior Aripiprazole |
|---|---|---|---|
| HeadacheNervous system disorders | 6/178 | 5/41 | 0/23 |
| Extrapyramidal disorderNervous system disorders | 2/178 | 1/41 | 2/23 |
| AnxietyPsychiatric disorders | 5/178 | 0/41 | 2/23 |
| InsomniaPsychiatric disorders | 10/178 | 3/41 | 0/23 |
| TremorNervous system disorders | 9/178 | 1/41 | 0/23 |
| Age, Continuous(Years) | Prior Brexiprazole | Prior Placebo | Prior Apripiprazole | Total |
|---|---|---|---|---|
| Mean | 39.1 ± 10.1 | 41.4 ± 11.2 | 41.2 ± 12 | 39.7 ± 10.5 |
| Sex: Female, Male(Participants) | Prior Brexiprazole | Prior Placebo | Prior Apripiprazole | Total |
|---|---|---|---|---|
| Female | 69 | 17 | 5 | 91 |
| Male | 110 | 24 | 19 | 153 |
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