A Phase 3 interventional study of OPC-34712 [Brexpiprazole] High Dose and Experimental: OPC-34712 [Brexpiprazole] Middle Dose in Acute Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 60 sites in 9 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 636 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:
Subjects with a current DSM-IV-TR Axis I diagnosis of:
Higher Dose, tablet, once daily, for six weeks
Drug: OPC-34712 [Brexpiprazole] High Dose
Middle Dose, tablet, once daily, for six weeks
Drug: Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Lower Dose, tablet, once daily, for six weeks
Drug: Experimental: OPC-34712 [Brexpiprazole] Low Dose
Placebo, once daily, for six weeks
Drug: Placebo
Higher dose, tablet, once daily, for six weeks
Middle dose, tablet, once daily, for six weeks
Lower dose, tablet, once daily, for six weeks
Placebo, once daily, for six weeks
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or 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 participant.
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time frame: Baseline to Week 1, 2, 3, 4, 5
Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
The severity of illness was rated using the CGI-S. To perform this assessment, the rater or 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 participant.
Time frame: Baseline to Week 1, 2, 3, 4 and 5
Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)
The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, 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 to determine 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 to Week 6
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score
For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score
For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: 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 for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6
The participant's overall improvement was rated using the CGI-I. The rater or study physician rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant's condition at screening/baseline. Response choices were: 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: Week 6
Response Rate at Week 6
Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.
Time frame: Week 6
Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score
The PEC consists of 5 PANSS items (excitement \[P4\], hostility \[P7\], tension \[G4\], uncooperativeness \[G8\], and poor impulse control \[G14\]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Discontinuation Rate for Lack of Efficacy at Week 6
Time frame: Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score
The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions \[P1\], hallucinatory behaviour \[P3\], grandiosity \[P5\], suspiciousness \[P6\], stereotyped thinking \[N7\], somatic concern \[G1\], unusual thought content \[G9\], lack of judgment and insight \[G10\]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score
The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect \[N1\], emotional withdrawal \[N2\], poor rapport \[N3\], passive/apathetic social withdrawal \[N4\], lack of spontaneity and conversation flow \[N6\], motor retardation \[G7\], active social avoidance \[G16\]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score
The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization \[P2\], difficulty in abstract thinking \[N5\], mannerisms and posturing \[G5\], disorientation \[G10\], poor attention \[G11\], disturbance of violation \[G13\], preoccupation \[G15\]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score
The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement \[P4\], hostility \[P7\], uncooperativeness \[G8\], poor impulse control \[G14\]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score
The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety \[G2\], guilt feelings \[G3\], tension \[G4\], depression \[G6\]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Time frame: Baseline to Week 6
The trial was conducted in 636 participants from 65 trial sites in 10 countries.
| Milestone | Brexpiprazole 4 mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Started | 180 | 182 | 90 | 184 |
| Completed | 121 | 124 | 56 | 109 |
| Not completed | 59 | 58 | 34 | 75 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 17 | 15 | 12 | 32 |
| Withdrew: Participant met withdrawal criteria | 1 | 0 | 1 | 0 |
| Withdrew: Physician decision | 1 | 1 | 0 | 3 |
| Withdrew: Withdrawal by subject | 31 | 24 | 13 | 21 |
| Withdrew: Protocol deviation | 2 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 7 | 17 | 7 | 18 |
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2 mg | Brexpiprazole 0.25 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score. | -19.65 ± 1.54 | -20.73 ± 1.55 | -14.90 ± 2.23 | -12.01 ± 1.60 |
The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or 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 participant.
| Units on a scale | Brexpiprazole 4 mg | Brexpiprazole 2 mg | Brexpiprazole 0.25 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score. | -1.20 ± 0.08 | -1.15 ± 0.08 | -0.85 ± 0.12 | -0.82 ± 0.09 |
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Week 1 | -4.38 ± 0.60 | -4.87 ± 0.59 | -2.52 ± 0.83 | -2.87 ± 0.60 |
| Week 2 | -9.51 ± 0.93 | -8.86 ± 0.93 | -3.28 ± 1.32 | -5.11 ± 0.95 |
| Week 3 | -12.78 ± 1.15 | -11.08 ± 1.16 | -5.71 ± 1.65 | -7.64 ± 1.18 |
| Week 4 | -16.50 ± 1.32 | -14.06 ± 1.32 | -8.86 ± 1.90 | -8.89 ± 1.35 |
| Week 5 | -18.61 ± 1.42 | -17.90 ± 1.43 | -11.87 ± 2.05 | -10.75 ± 1.47 |
The severity of illness was rated using the CGI-S. To perform this assessment, the rater or 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 participant.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Week 1 | -0.16 ± 0.04 | -0.16 ± 0.04 | -0.11 ± 0.05 | -0.14 ± 0.04 |
| Week 2 | -0.46 ± 0.05 | -0.43 ± 0.05 | -0.18 ± 0.07 | -0.30 ± 0.05 |
| Week 3 | -0.72 ± 0.06 | -0.60 ± 0.06 | -0.33 ± 0.09 | -0.51 ± 0.07 |
| Week 4 | -0.96 ± 0.07 | -0.73 ± 0.07 | -0.58 ± 0.11 | -0.54 ± 0.08 |
| Week 5 | -1.08 ± 0.08 | -1.03 ± 0.08 | -0.73 ± 0.11 | -0.69 ± 0.08 |
The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, 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 to determine 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 | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) | 12.72 ± 0.93 | 13.15 ± 0.93 | 11.84 ± 1.33 | 10.26 ± 0.98 |
For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score | -6.78 ± 0.51 | -6.57 ± 0.52 | -5.46 ± 0.74 | -4.35 ± 0.54 |
For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: 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 for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score | -3.65 ± 0.36 | -4.02 ± 0.36 | -3.31 ± 0.53 | -2.24 ± 0.38 |
The participant's overall improvement was rated using the CGI-I. The rater or study physician rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant's condition at screening/baseline. Response choices were: 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 | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6 | 2.94 ± 1.29 | 2.94 ± 1.34 | 3.37 ± 1.46 | 3.48 ± 1.47 |
Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.
| Percentage of participants | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Response Rate at Week 6 | 46.07 | 47.78 | 39.08 | 30.34 |
The PEC consists of 5 PANSS items (excitement \[P4\], hostility \[P7\], tension \[G4\], uncooperativeness \[G8\], and poor impulse control \[G14\]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score | -2.75 ± 0.34 | -2.87 ± 0.34 | -1.99 ± 0.49 | -1.64 ± 0.36 |
| Percentage of participants | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Discontinuation Rate for Lack of Efficacy at Week 6 | 3.93 | 9.44 | 8.05 | 10.11 |
The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions \[P1\], hallucinatory behaviour \[P3\], grandiosity \[P5\], suspiciousness \[P6\], stereotyped thinking \[N7\], somatic concern \[G1\], unusual thought content \[G9\], lack of judgment and insight \[G10\]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score | -7.23 ± 0.51 | -7.37 ± 0.51 | -5.78 ± 0.73 | -4.89 ± 0.53 |
The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect \[N1\], emotional withdrawal \[N2\], poor rapport \[N3\], passive/apathetic social withdrawal \[N4\], lack of spontaneity and conversation flow \[N6\], motor retardation \[G7\], active social avoidance \[G16\]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score | -4.10 ± 0.37 | -4.48 ± 0.37 | -3.66 ± 0.54 | -2.80 ± 0.38 |
The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization \[P2\], difficulty in abstract thinking \[N5\], mannerisms and posturing \[G5\], disorientation \[G10\], poor attention \[G11\], disturbance of violation \[G13\], preoccupation \[G15\]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score | -3.72 ± 0.36 | -3.94 ± 0.36 | -2.69 ± 0.52 | -1.97 ± 0.37 |
The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement \[P4\], hostility \[P7\], uncooperativeness \[G8\], poor impulse control \[G14\]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score | -1.90 ± 0.28 | -1.91 ± 0.28 | -1.15 ± 0.41 | -0.82 ± 0.30 |
The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety \[G2\], guilt feelings \[G3\], tension \[G4\], depression \[G6\]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
| Units on a scale | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score | -3.40 ± 0.25 | -3.70 ± 0.25 | -3.27 ± 0.35 | -3.05 ± 0.26 |
Collected over Adverse events were recorded from the time the participant signs the informed consent form, throughout the 6-week treatment period and until 30 days after the last dose of study medication.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole 4mg | — | 2/180 (1.1%) | 64/180 (35.6%) |
| Brexpiprazole 2 mg | — | 4/182 (2.2%) | 53/182 (29.1%) |
| Brexpiprazile 0.25 mg | — | 4/90 (4.4%) | 25/90 (27.8%) |
| Placebo | — | 7/184 (3.8%) | 65/184 (35.3%) |
| Event | Brexpiprazole 4mg | Brexpiprazole 2 mg | Brexpiprazile 0.25 mg | Placebo |
|---|---|---|---|---|
| SchizophreniaPsychiatric disorders | 2/180 | 2/182 | 2/90 | 2/184 |
| Acute myocardial infarctionCardiac disorders | 0/180 | 0/182 | 1/90 | 0/184 |
| Psychotic disorderPsychiatric disorders | 0/180 | 1/182 | 1/90 | 2/184 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/180 | 1/182 | 0/90 | 0/184 |
| Gastric ulcerGastrointestinal disorders | 0/180 | 0/182 | 0/90 | 1/184 |
| Grand mal convulsionNervous system disorders | 0/180 | 0/182 | 0/90 | 1/184 |
| Schizophrenia, paranoid typePsychiatric disorders | 0/180 | 0/182 | 0/90 | 1/184 |
| Event | Brexpiprazole 4mg | Brexpiprazole 2 mg | Brexpiprazile 0.25 mg | Placebo |
|---|---|---|---|---|
| HeadacheNervous system disorders | 22/180 | 17/182 | 9/90 | 15/184 |
| AgitationPsychiatric disorders | 13/180 | 11/182 | 4/90 | 19/184 |
| InsomniaPsychiatric disorders | 15/180 | 16/182 | 8/90 | 18/184 |
| SchizophreniaPsychiatric disorders | 10/180 | 7/182 | 6/90 | 18/184 |
| AkathisiaNervous system disorders | 13/180 | 8/182 | 0/90 | 4/184 |
| DiarrhoeaGastrointestinal disorders | 7/180 | 3/182 | 5/90 | 3/184 |
| NauseaGastrointestinal disorders | 6/180 | 10/182 | 1/90 | 8/184 |
| Age, Continuous(Years) | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 40.8 ± 11.0 | 39.6 ± 10.2 | 40.5 ± 11.4 | 39.7 ± 10.8 | 40.1 ± 10.8 |
| Sex: Female, Male(Participants) | Brexpiprazole 4mg | Brexpiprazole 2mg | Brexpiprazole 0.25 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 69 | 71 | 29 | 66 | 235 |
| Male | 111 | 111 | 61 | 118 | 401 |
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