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The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-34712 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-34712 | Drug | Phase A: 1-2 mgs/day by mouth, max of 4 wks. Phase B: 1-4 mgs/day by mouth, up to 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 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. | From Baseline up to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
Subjects with a current DSM-IV-TR Axis I diagnosis of:
Subjects presenting with a first episode of schizophrenia
Other protocol specific exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandar Skuban, M.D. | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35226 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35235720 | Derived | Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793. | |
| 34901863 | Derived | Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan. |
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Enrollment was drawn from eligible participants who could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia and included rollover participants from the double-blind, phase-3 efficacy trials (ie, Trial NCT01393613, Trial NCT01396421, and Trial NCT01668797) and de novo participants from select sites.
This trial was conducted in a total of 1072 participants (1044 of whom entered the open-label treatment phase) at 202 trial sites in the following 18 countries: Japan, Korea, Malaysia, Philippines, Taiwan, Croatia, Latvia, Poland, Romania, Russia, Serbia, Turkey, Ukraine, Columbia, Mexico, Canada, Puerto Rico, and United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Prior Brexpiprazole | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 . |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase A |
|
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| From Baseline up to 52 Weeks |
| Mean 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. | From Baseline up to 52 Weeks |
| Mean 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. | From Baseline up to 52 Weeks |
| Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score | 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. | From Baseline up to 52 Weeks |
| Mean Change From Baseline in Personal and Social Performance Scale 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. | From Baseline up to 52 Weeks |
| Mean Clinical Global Impression - Improvement Score | 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. | From Baseline up to 52 Weeks |
| 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. | From Baseline up to 52 Weeks |
| Discontinuation Rate for Lack of Efficacy | Discontinuation rate for the participants who discontinued due to lack of efficacy were examined. | From Baseline up to 52 Weeks |
| Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score | 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). | From Baseline up to 52 Weeks |
| Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome). | From Baseline up to 52 Weeks |
| Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome). | From Baseline up to 52 Weeks |
| Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome). | From Baseline up to 52 Weeks |
| Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome). | From Baseline up to 52 Weeks |
| Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome). | From Baseline up to 52 Weeks |
| Little Rock |
| Arkansas |
| 72201 |
| United States |
| Little Rock | Arkansas | 72205 | United States |
| Springdale | Arkansas | 72764 | United States |
| Anaheim | California | 92805 | United States |
| Cerritos | California | 90703 | United States |
| Escondido | California | 92025 | United States |
| Garden Grove | California | 92845 | United States |
| Glendale | California | 91206 | United States |
| Long Beach | California | 90813 | United States |
| National City | California | 91950 | United States |
| Oakland | California | 94612 | United States |
| Oceanside | California | 92056 | United States |
| Pico Rivera | California | 90660 | United States |
| San Diego | California | 92102 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92123 | United States |
| Torrance | California | 90502 | United States |
| Washington D.C. | District of Columbia | 20016 | United States |
| Bradenton | Florida | 34208 | United States |
| Leesburg | Florida | 34748 | United States |
| Maitland | Florida | 32751 | United States |
| Miami | Florida | 33143 | United States |
| Miami Springs | Florida | 33166 | United States |
| North Miami | Florida | 33162 | United States |
| Tampa | Florida | 33613 | United States |
| Chicago | Illinois | 60611 | United States |
| Hoffman Estates | Illinois | 60169 | United States |
| Joliet | Illinois | 60435 | United States |
| Oak Brook | Illinois | 60523 | United States |
| Overland Park | Kansas | 66212 | United States |
| Lake Charles | Louisiana | 70629 | United States |
| Shreveport | Louisiana | 71104 | United States |
| Flowood | Mississippi | 39232 | United States |
| Saint Charles | Missouri | 63301 | United States |
| St Louis | Missouri | 63109 | United States |
| St Louis | Missouri | 63141 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Buffalo | New York | 14215 | United States |
| Cedarhurst | New York | 11516 | United States |
| Jamaica | New York | 11432 | United States |
| Rochester | New York | 14618 | United States |
| Staten Island | New York | 10305 | United States |
| Staten Island | New York | 10312 | United States |
| Dayton | Ohio | 45417 | United States |
| Allentown | Pennsylvania | 18104 | United States |
| Norristown | Pennsylvania | 19403 | United States |
| Charleston | South Carolina | 29407 | United States |
| Memphis | Tennessee | 38119 | United States |
| Austin | Texas | 78731 | United States |
| Austin | Texas | 78754 | United States |
| Dallas | Texas | 75231 | United States |
| Dallas | Texas | 75243 | United States |
| Houston | Texas | 77007 | United States |
| Richmond | Virginia | 23230 | United States |
| Kirkland | Washington | 98033 | United States |
| Burlington | Ontario | L7R 4E2 | Canada |
| Chatham | Ontario | N7M 5L9 | Canada |
| Barranquilla | 00000 | Colombia |
| Bello | 00000 | Colombia |
| Bogotá | 00000 | Colombia |
| Pereira | 00000 | Colombia |
| Rijeka | 51000 | Croatia |
| Zagreb | 10090 | Croatia |
| Fujisawa-shi | Kanagawa | 251-8530 | Japan |
| Kumamoto | Kumamoto | 861-8002 | Japan |
| Kunigami-gun | Okinawa | 904-1201 | Japan |
| Sakai-shi | Osaka | 590-0018 | Japan |
| Daugavpils | LV-5417 | Latvia |
| Jelgava | LV-3008 | Latvia |
| Liepāja | LV-3401 | Latvia |
| Riga | LV-1005 | Latvia |
| Strenči | LV-4730 | Latvia |
| Kota Bharu | Kelantan | 15586 | Malaysia |
| Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Kajang | Selangor | 43000 | Malaysia |
| Ipoh | 31250 | Malaysia |
| Jalan Greentown | 30450 | Malaysia |
| Sabak Bernam | 88815 | Malaysia |
| Col. Florida | Mexico City | 01030 | Mexico |
| Monterrey | Nuevo León | 64060 | Mexico |
| San Luis Potosí City | San Luis Potos | 78218 | Mexico |
| Cebu City | 6000 | Philippines |
| Davao City | 8000 | Philippines |
| Manila | 1000 | Philippines |
| Choroszcz | 16-070 | Poland |
| Gdansk | 80-282 | Poland |
| Gdansk | 80-952 | Poland |
| Lodz | 91-229 | Poland |
| San Juan | 00918 | Puerto Rico |
| San Juan | 00927 | Puerto Rico |
| Arad | 310022 | Romania |
| Brasov | 500123 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 030442 | Romania |
| Bucharest | 041914 | Romania |
| Cluj-Napoca | 400012 | Romania |
| Craiova | 200473 | Romania |
| Focşani | 620165 | Romania |
| Iași | 700282 | Romania |
| Piteşti | 110069 | Romania |
| Targoviste | 130086 | Romania |
| Arkhangelsk | 163530 | Russia |
| Moscow | 117152 | Russia |
| Moscow | 119435 | Russia |
| Moscow Region | 142601 | Russia |
| Nizhny Novgorod | 603155 | Russia |
| Petrozavodsk | 185000 | Russia |
| Saint Petersburg | 190005 | Russia |
| Saint Petersburg | 190121 | Russia |
| Saint Petersburg | 192019 | Russia |
| Saint Petersburg | 194214 | Russia |
| Saint Petersburg | 197341 | Russia |
| Samara | 443016 | Russia |
| Saratov | 410060 | Russia |
| Tomsk | 634014 | Russia |
| Village Nikolskoe | 188357 | Russia |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Novi Kneževac | 23330 | Serbia |
| Novi Sad | 21000 | Serbia |
| Bratislava | 82606 | Slovakia |
| Michalovce | 07101 | Slovakia |
| Rimavská Sobota | 97912 | Slovakia |
| Rožňava | 04801 | Slovakia |
| Incheon | 400-711 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 136-705 | South Korea |
| Seoul | 137-710 | South Korea |
| Seoul | 143-711 | South Korea |
| Kashsiung | 802 | Taiwan |
| New Taipei City | 249 | Taiwan |
| Taipei | 110 | Taiwan |
| Taoyuan County | 333 | Taiwan |
| Diyarbakır | 21280 | Turkey (Türkiye) |
| Kocaeli | 41380 | Turkey (Türkiye) |
| Chernihiv | 14000 | Ukraine |
| Dnipropetrovsk | 49027 | Ukraine |
| Dnipropetrovsk | 49115 | Ukraine |
| Hlevakha | 08631 | Ukraine |
| Kharkiv | 61068 | Ukraine |
| Kherson, Vil. Stepanivka | 73488 | Ukraine |
| Kyiv | 02660 | Ukraine |
| Kyiv | 04080 | Ukraine |
| Lviv | 79021 | Ukraine |
| Odesa | 65014 | Ukraine |
| Simferopol | 95006 | Ukraine |
| Vinnytsia | 21005 | Ukraine |
| 29985680 | Derived | Newcomer JW, Eriksson H, Zhang P, Weiller E, Weiss C. Changes in metabolic parameters and body weight in brexpiprazole-treated patients with acute schizophrenia: pooled analyses of phase 3 clinical studies. Curr Med Res Opin. 2018 Dec;34(12):2197-2205. doi: 10.1080/03007995.2018.1498779. Epub 2018 Jul 27. |
| 29415258 | Derived | Forbes A, Hobart M, Ouyang J, Shi L, Pfister S, Hakala M. A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia. Int J Neuropsychopharmacol. 2018 May 1;21(5):433-441. doi: 10.1093/ijnp/pyy002. |
| 27188270 | Derived | 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. |
| FG001 |
| Prior Placebo |
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| FG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase B |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prior Brexpiprazole | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| BG001 | Prior Placebo | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| BG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) | 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. | Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score. | Posted | Number | percentage of participants | From Baseline up to 52 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score | 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. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean 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 Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean 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 Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score | 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. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Personal and Social Performance Scale 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. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Clinical Global Impression - Improvement Score | 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. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Number | percentage of participants | From Baseline up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Discontinuation Rate for Lack of Efficacy | Discontinuation rate for the participants who discontinued due to lack of efficacy were examined. | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Number | percentage of participants | From Baseline up to 52 Weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score | 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). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
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| Secondary | Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
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| Secondary | Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
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| Secondary | Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
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| Secondary | Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
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| Secondary | Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score | Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome). | The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline up to 52 Weeks |
|
The trial required that participants be actively monitored for AEs up to 30 (+2) days after the last dose of study drug, up to 52 weeks.
An adverse event (AE) was defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. Serious adverse event (SAE) includes any AE that meets the either one or more seriousness criteria mentioned in the study protocol. An immediately Reportable Event (IRE) was defined as any SAE, AE/pregnancy cases that necessitates discontinuation of IMP/potential Hy's Law cases. Included participants who received at least 1 dose of open-label IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | De Novo (Phase A) | Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase. NOTE: 12 participants from the trial P33110232 were excluded in this analysis. | 4 | 226 | 0 | 226 | ||
| EG001 | Prior Brexpiprazole (Phase B) | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: Six participants from the trial P33110231 were excluded in this analysis. | 90 | 605 | 166 | 605 | ||
| EG002 | Prior Placebo (Phase B) | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis. | 18 | 202 | 53 | 202 | ||
| EG003 | De Novo (Phase B) | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase. NOTE: Five participants from Phase B - Denovo were excluded in this analysis. | 25 | 224 | 95 | 256 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MEDDRA v18.0. | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MEDDRA v18.0. | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MEDDRA v18.0. | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MEDDRA v18.0. | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA v18.0. | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MEDDRA v18.0. | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Schizophrenia, Paranoid type | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA v18.0. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | MEDDRA v18.0. | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA v18.0. | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA v18.0. | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Subject Met Withdrawal Criteria |
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| Physician Decision |
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| Withdrawal by Subject |
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| Protocol Deviation |
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| Lack of Efficacy |
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| Male |
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| With TEAEs |
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| With SAEs |
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| OG001 | Prior Placebo | Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
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| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
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| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
|
| OG002 | De Novo | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
| OG003 | Total | Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. |
|
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